Abstract
India has a huge burden of head and neck cancer and specifically oral cancer. Supportive oral care is not a standard of care in our population and is often neglected. Currently, there are no specific guidelines for such care in India which could be followed. The aim of this study is to validate a novel institutional supportive oral care protocol (SOCP) for head and neck cancer patients. This protocol is specific to our population developed for head and neck/dental oncology experts working in cancer centres to provide comprehensive care. This is a cross-sectional validity study. Fifteen dental oncology experts working in cancer centres/hospitals across India and six oncology experts from our centre were enrolled. All experts provided their inputs on 41 points of the SOCP. The data was analysed for item validity, content validity index and inter-rater agreement. The statistical analyses used were kappa measure for inter-rater agreement and content validity index for item-wise agreement. Out of 861 responses from all the reviewers, 91% agreed, 8.4% agreed with modification and 0.6% disagreed. The content validity index and agreement between reviewers ranged from 0.9 to 1 for kappa measure. The SOCP of our institution was shown to be a valid protocol. SOCP addresses oral and dental supportive care and rehabilitation as part of overall comprehensive care for head and neck cancer patients in our population.
Keywords: Head and neck cancer, Oral cancer, Radiotherapy, Supportive oral care, Dental oncology
Introduction
As per the Global Cancer Observatory (GLOBACAN), India’s incidence of oral cancer is 11.4%. More than one lakh individuals were diagnosed with oral cancer in India in 2018 [1, 2]. Apart from primary cancer treatment, supportive care for head and neck cancer is the standard of care in developed countries, but in India, supportive oral care is neglected. This is due to lack of integration of dental expert in supportive care team of oncology professionals. Patients are not aware of the oral health supportive care needs during the cancer treatment and become aware only when the complications arise. Inclusion of oral supportive care increases quality of life in oral cancer patients [3, 4].
To the best of our knowledge, there are no published guidelines available for our population regarding standard of oral care in head and neck cancer patients. In the context of cancer care and treatment, now is the time of ‘Not just adding years in life, but adding life in the years’.
In this context, India requires population-specific guidelines tailored as per our population needs. Based upon our experience and training, we have develop an institutional supportive oral care protocol (SOCP), for resource-limited setting like ours, which we are following in our centre from the past few years. We aim to standardise and validate our institutional SOCP and document it as a standard of oral care for cancer patients in resource-limited setting like ours.
Subjects and Methods
The present study was a cross-sectional survey with the intent to standardised and validate supportive oral care protocol (SOCP) for dentists working at cancer centres for head and neck cancer patients in our population (Annexure). The study was approved by the ethics committee of our university (vide letter no. SRHU/HIMS/ETHICS/2019/115).
A PubMed search with MeSH keywords ‘Oral care protocol’ and ‘Head & neck cancer’ was done. A total of 131 searches were identified; taking into account publications for Indian population, only two publications were found; on further analysis, these two articles were not related to standardised supportive oral care protocol for dentists working in head and neck cancer patients. Hence, no publication in this context was found. To the best of our knowledge, there are only few review articles on oral care in head and neck radiation, but a structural protocol is nonexisting for our population [5–7]. List of supportive care dental experts was formulated from various cancer centres/hospitals in India. Criteria such as (a) publication in cancer supportive care, (b) working in cancer care setting and (c) part of cancer research group were used to formulate the list. Most of the reviewers could only qualify as per criteria of working in cancer care setting.
Out of 24 regional cancer centres in India, as per information available on their respective official websites, only ten centres had designated dentists mentioned as an integral part of cancer team. With the help of convenient sampling method, snowball referral and the aforementioned criteria, a total of 24 reviewers were identified; these included dental reviewers from regional cancer centres (ten), Government/Trust-aided cancer centres (four), medical institutions offering cancer treatment from our state (five), dental colleges from India fulfilling the aforementioned criteria (three) and international dental supportive care experts of reputed national government cancer centres in Tokyo, Japan (two).
All identified dental experts were contacted via telephone/email, and only those who expressed interest in review process were invited via email for a written approval and consent with view of intent to review the documents (18 reviewers). Only those who sent the review sheets complete in all aspects (15 reviewers) were included in the study. From a total of 24, only 15 reviewers qualified to be part of the study; reasons for exclusion were as follows: (a) did not responded to the invitation, (b) did not returned the protocol in time or (c) returned incompletely filled review sheets.
The reviewers represented various regions/sates of India, including Thiruvananthapuram (Kerala), Kolkata, Haryana, Gujarat, Manipal (Karnataka), Uttar Pradesh and Uttarakhand, thus giving wide inputs from various populations across India. Inputs from international reviewers (Tokyo, Japan) where supportive oral care for cancer patients is the standard of care in cancer patients were also taken.
Academic qualification of the dental reviewers ranged from under-graduation (1), post-graduation (12) and PhD (2) with experience ranging from 2 to 15 years. The dental experts were designated as DE1, DE2, DE3… to DE15. Medical experts were also included in the review comprising 2 surgical oncologists, 2 radiation oncologists, 1 hemato-oncologists and 1 medical oncologist from our centre. Theses medical experts were designated as ME1, ME2, ME3, ME4, ME5 and M6. All medical reviewers were with post-graduate qualification with clinical experience ranging from 7 to 30 years.
The study was conducted from 25 January to 28 February 2020. One-month time was given for submission of response, before closing the documents. Microsoft Excel program and IBM SPSS Statistics for Windows, Version 22.0. IBM Corp., Armonk, NY, were used to calculate agreement. All the responses were recorded and content validity index of more than 0.78 was considered as valid for agreement [8]. This is the widely accepted method of validation in health care. Content validity index (IVC) and item-wise agreement were calculated for both dental and medical experts.
Results
Fifteen supportive care dental experts and six oncology experts participated in the validation process. The SOCP had 41 items to be reviewed with options such as (a) either agree (A), (b) agree with modification (AM) or (c) do not agree (DA).
Out of the total 861 responses from dental and medical experts, 91% of responses were of ‘agree’ and only 0.6% responses were of ‘do not agree’ (Table 1). Each item was assessed for every reviewer to reach its validity and agreement (IVC). SOCP was assessed for definition and level wise (Annexure).
Table 1.
Level of agreement amongst dental experts and medical experts on 41 items
| Decision | Dental experts, N (%) | Oncology experts, N (%) | Combined, N (%) |
|---|---|---|---|
| 1. Agree (A) | 561 (91%) | 225 (91.5%) | 786 (91%) |
| 2.Agree with modification (AM) | 50 (8%) | 21 (8.5%) | 71 (8%) |
| 3. Do not agree (DA) | 4 (0.6%) | 0 | 4 (0.6%) |
| 615 | 246 | 861 |
Amongst dental reviewers, there was disagreement on dental disease burden and x-ray investigation, use of chlorhexidine and dental x-ray need. All other dental reviewers either agreed or agreed with modification to all the steps of SOCP. All medical reviewers agreed or agreed with modification to all the steps of SOCP (Tables 1, 2, 3, and 4).
Table 2.
Item-wise agreement for level I care amongst reviewers and their respective content validity index (CVI) values
| Definition of level I care | A/AM/DA dental experts (15) | CVI-A; CVI-(A+AM) | A/AM/DA medical experts (6) | CVI-A; CVI-(A+AM) |
|---|---|---|---|---|
| Definition | 9/6/0 | 0.6/1 | 6/0/0 | 1/1 |
| Step 1 Initial referral and assessment phase | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| Step 2 Preparation and assessment phase | ||||
| a) Rationale of oral care | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| b) Dental disease burden | 13/1/1 | 0.8/0.9 | 5/1/0 | 0.8/1 |
| c) Oral hygiene status | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| d) Trismus assessment | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| e) Plan for dental prosthesis | 15/0/0 | 1/1 | 5/1/0 | 0.8/1 |
| f) Plan for obturator if needed | 13/2/0 | 0.8/1 | 6/0/0 | 1/1 |
| g) Plan for radiation sparing appliances if needed | 14/1/0 | 0.9/1 | 5/1/0 | 0.8/1 |
| h) Dental guard for protection during surgery if needed | 14/1/0 | 0.9/1 | 5/1/0 | 0.8/1 |
| i) Edentulous patients assessment | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| j) Neo-adjuvant chemo-dental assessment | 13/2/0 | 0.8/1 | 5/1/0 | 0.8/1 |
| k) Palliative intent assessment | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| l) Osteoradionecrosis risk awareness | 12/3/0 | 0.8/1 | 5/1/0 | 0.8/1 |
| Step 3 Dental treatment phase | ||||
| a) Oral prophylaxis | 14/1/0 | 0.9/1 | 6/0/0 | 1/1 |
| b) Extraction schedule | 9/6/0 | 0.6/1 | 5/1/0 | 0.8/1 |
| c) Fluoride | 13/2/0 | 0.8/1 | 6/0/0 | 1/1 |
| d) Oral hygiene techniques plan, diet modification and tobacco cessation | 14/1/0 | 0.9/1 | 6/0/0 | |
| Step 4 Referral to radiotherapy | ||||
| a) Assessment of oral tissue healing | 14/1/0 | 0.9/1 | 6/0/0 | 1/1 |
| b) Reinforcement in oral hygiene plan | 15/0/0 | 1/1 | 5/1/0 | 0.8/1 |
A agree, AM agree with modification, DA do not agree, CVI-A validity index for agree, CVI-(A+AM) validity index for agree + agree with modification
Table 3.
Item-wise agreement for level II care amongst reviewers and their respective content validity index (CVI) values
| Level II care | A/AM/DA dental experts (15) | CVI-A; CVI-(A+AM) | A/AM/DA medical experts (6) | CVI-A; CVI-(A+AM) |
|---|---|---|---|---|
| Step 1 Preparation for cancer therapy | ||||
| a) Patient evaluation and level II duration | 14/1/0 | 0.9/1 | 4/2/0 | 0.6/1 |
| b) Provision of parallel entry | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| Step 2 Oral hygiene assessment during cancer therapy | ||||
| a) Weekly assessment | 14/1/0 | 0.9/1 | 4/2/0 | 0.6/1 |
| b) Brushing and oral care during radiotherapy | 12/3/0 | 0.8/1 | 6/0/0 | 1/1 |
| c) Use of rinses sodium bicarbonate and chlorhexidine | 11/3/1 | 0.7/0.9 | 5/1/0 | 0.8/1 |
| d) Oral care in nasogastric tube | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| e) Oral care in oral-antral communication | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| f) Dentures care | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| Step 3 Management of acute symptoms during radiotherapy and oral hygiene | ||||
| a) Use of various oral care adjutant for acute side effects | 15/0/0 | 1/1 | 5/1/0 | 0.8/1 |
| b) Assessment time at end of level II | 12/3/0 | 0.8/1 | 3/3/0 | 0.5/1 |
A agree, AM agree with modification, DA do not agree, CVI-A validity index for agree, CVI-(A+AM) validity index for agree + agree with modification
Table 4.
Item-wise agreement for level III care amongst reviewers and their respective content validity index (CVI) values
| Level III care | A/AM/DA | CVI-A; CVI-(A+AM) | A/AM/DA medical experts (6) | CVI-A; CVI-(A+AM) |
|---|---|---|---|---|
| Step 1 Oral assessment and treatment phase | ||||
| a) Care in level III | 15/0/0/ | 1/1 | 6/0/0 | 1/1 |
| b) Parallel entry provision | 14/1/0 | 0.9/1 | 6/0/0 | 1/1 |
| c) Late side effect evaluation | 11/3/1 | 0.7/0.9 | 6/0/0 | 1/1 |
| d) Risk of necrosis of jaw bone | 12/3/0 | 0.8/1 | 6/0/0 | 1/1 |
| e) Reinforcement and follow-up | 14/1/0 | 0.9/1 | 5/1/0 | 0.8/1 |
| f) Dental x-ray, treatment and plan for rehabilitation | 11/3/1 | 0.7/0.9 | 5/1/0 | 0.8/1 |
| Step 2 Reinforcement and care | ||||
| a) Risk of radiation decay reinforced | 14/1/0 | 0.9/1 | 6/0/0 | 1/1 |
| b) Fluoride application | 13/2/0 | 0.8/1 | 6/0/0 | 1/1 |
| c) Follow-up classification | 15/0/0 | 1/1 | 5/1/0 | 0.8/1 |
| d) Diet modification reinforcement | 15/0/0 | 1/1 | 6/0/0 | 1/1 |
| e) Reinforcement for tobacco cessation and counselling | 13/2/0 | 0.8/1 | 6/0/0 | 1/1 |
A agree, AM agree with modification, DA do not agree, CVI-A validity index for agree, CVI-(A+AM) validity index for agree + agree with modification
For dental supportive care experts, the inter-rater agreement (IVC) was in the range of 0.9–1 for kappa measure Table 5. The medical experts presented with an agreement of 1 for kappa measure.
Table 5.
Inter-rater validity agreement (IVC) amongst dental experts and their respective kappa measure
| IVC | DE1 | DE2 | DE3 | DE4 | DE5 | DE6 | DE7 | DE8 | DE9 | DE10 | DE11 | DE12 | DE13 | DE14 | DE15 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DE1 | 0.9 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0.9 | 1 | 1 | 1 | 0.9 | |
| DE2 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | ||
| DE3 | 0.9 | 1 | 1 | 1 | 1 | 1 | 1 | 0.9 | 1 | 1 | 1 | 1 | |||
| DE4 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | ||||
| DE5 | 1 | 1 | 1 | 1 | 1 | 0.9 | 1 | 1 | 1 | 1 | |||||
| DE6 | 1 | 1 | 1 | 1 | 0.9 | 1 | 1 | 1 | 1 | ||||||
| DE7 | 1 | 1 | 1 | 0.9 | 1 | 1 | 1 | 1 | |||||||
| DE8 | 1 | 1 | 0.9 | 1 | 1 | 1 | 1 | ||||||||
| DE9 | 1 | 0.9 | 1 | 1 | 1 | 1 | |||||||||
| DE10 | 0.9 | 1 | 1 | 1 | 1 | ||||||||||
| DE11 | 1 | 1 | 1 | 1 | |||||||||||
| DE12 | 1 | 1 | 1 | ||||||||||||
| DE13 | 1 | 1 | |||||||||||||
| DE14 | 1 | ||||||||||||||
| DE15 |
Discussion
The study was designed to address two key outcomes; the first was to assess the validity of SOCP with supportive care dental oncology experts working in cancer hospitals/centres. The second outcome was to assess the validation of SOCP with primary oncology professionals at our centre for integration of SOCP in treatment for comprehensive care.
International guidelines are not fully applicable to our setting due to difference in patient burden, available resources, economic constraints and treatment option opted [9]. There are also higher dental diseases burden at baseline and lack of government insurance for dental rehabilitation under major national health schemes.
National guidelines do not emphasise oral dental care integration in detail [10–12]. Hence, a supportive oral care protocol is essential for addressing this essential aspect of cancer care in head and neck cancer patients.
For definition, keywords such as preventive, hygienic, focus of infection, oral distress, pain and suffering were suggested. To make the definition more inclusive, some key such as hygienic, prevention, distress and oral foci of infection was included in the definition.
In level I care, all reviewers agreed with initial assessment and referral. This step emphasises on the need of clear and documented referral with all necessary clinical information to be shared with the supportive care dentist by the treating oncologist. This allows the dentist to formulate effective and inclusive oral dental care and rehabilitation plan.
The second step of level I is about preparation and assessment phase for dental disease burden and x-ray investigation. DE2 does not agree with the need of orthopantomogram x-ray and suggested to rely on clinical judgement. This suggestion was not accepted as only clinical examination fails to rule out any pathology associated in periapical area of teeth and any remaining root stumps.
All dental reviewers agreed for oral hygiene status, trismus assessment and plan for dental prosthesis. This phase is very essential and requires a detailed understanding of patient’s needs and viable option available for oral rehabilitation and oral health maintenance.
For osteoradionecrosis (ORN) awareness, DE4 suggests that the risk of ORN is lifelong. DE9 suggested a period of 15 months post radiotherapy to wait before any extractions. Similar information is communicated with the patients in SOCP. Emphasis is made about the risk of ORN being high for first-year post radiotherapy due to xerostomia leading to radiation decay. Xerostomia gradually recovers over time; thus, the risk of ORN is high in the first few years post radiotherapy but continues lifelong [13, 14]. To make it more descriptive, a text was added in the point. Avoiding extractions in the field of radiation, doing root canal treatment (RCT) and de-crowning of tooth to retain root stumps are advisable. In cases where extraction is a must, it is done following all principles of minimal trauma and primary closure and under consent for risk of ORN.
In step three of level I, single root canals with no periapical abscess are obturated in two visit time in this level. In teeth with periapical pathology, pulpectomy is done in this phase and obturation is completed post radiotherapy in level III.
For the extraction schedule, dental experts suggested extractions of patients to best scheduled at the same time of surgery. Others suggest to wait 2–4 weeks after extraction before starting radiotherapy. SOCP allows a minimal of 7–10 days of healing post extraction as a minimal criterion to start radiotherapy; this is followed in patients who are at the advanced stage of cancer and cancer treatment is to be initiated at a priority. In patients with initial stages of cancer, an adequate healing time of 2–3 weeks is given depending on the number and kind of dental extraction done [15–18].
In regard to fluoride enrolment in level I care, DE11 agreed with modification and suggested to also prescribe sodium fluoride 1.1% tooth paste. In SOCP, fluorinated toothpastes of 1000 ppm are advised lifelong, along with professionally applied fluoride varnish and gels ranging from 22,000 to 28,000 ppm of fluoride and 200 ppm fluorinated mouthwash as per schedule [19–22].
Medical experts agreed with all points of step III; ME5 agreed with modification with extraction schedule and suggested to plan for extraction of teeth (healthy) which would cause trauma in postoperative/treatment period. The modification was accepted as teeth which do not have any dental ailment, but which continue to give trauma to surgical site, result in ulceration and increase chance of reoccurrence.
Level II care is designed for patients who are scheduled to receive radiotherapy and chemotherapy with provision of parallel entry. For brushing and oral care, DE3, DE6 and DE7 agreed with modification and suggested not to stop brushing during radiotherapy and suggested the use of soft brush and bland toothpaste. The patients in our setting mostly receive conventional radiotherapy and these patients have more incidence of oral mucositis with higher grades. This makes it difficult to brush even with a soft head and kid size brushes; in such patients, soft sponges/gauzes are used to maintain oral hygiene [23]. For patients who do not develop painful ulceration, oral hygiene is continued with soft small head brushes soaked in antimicrobial rinse such as chlorhexidine [24].
For use of chlorhexidine during radiotherapy, DE4 and DE8 agreed with modification, DE4 suggested on not using chlorhexidine often and DE8 suggested to stop chlorhexidine once the oral mucositis appears, and start after 2 weeks after resolution of oral mucositis. DE2 and DE11 did not agree with the use of chlorhexidine during radiotherapy. DE2 mentioned chlorhexidine as contraindication, while DE11 suggested not to use chlorhexidine until 2 months post radiotherapy until oral mucositis is resolved. There is lack of studies to arrive at consensus on the role of chlorhexidine in oral mucositis [25]. In our experience, use of chlorhexidine is very essential for good oral hygiene during radiotherapy, as most of the patients are not able to brush during the complete duration of radiotherapy. It is further emphasised that chlorhexidine has no role in oral mucositis management but has an active role in oral hygiene management. All medical experts agreed on the use of chlorhexidine.
For assessment time at the end of level II, DE1 suggested recall also for post chemotherapy patients, while DE4 and DE11 suggested recall at 8 weeks and 6 weeks post radiotherapy respectively. Recall is very essential for minimising known complications of cancer therapies.
ME3 agreed with modification to acute side effect adjuvants and suggested a joint clinic should be available to provide a comprehensive care comprising radiation oncologist and dental expert. In SOCP, all side effects of radiotherapy are primarily assessed by the radiation oncologist and the dentist provides supportive care for oral cavity and oral rehabilitation.
For late side effect prevention, DE1 suggested also to include post-surgery side effects, and DE2 suggested to emphasise on xerostomia as its most prevalent symptom. In SOCP, all side effects due to surgery, chemotherapy and radiotherapy are addressed. Xerostomia is a prevalent symptom and xerostomia aids such as artificial saliva spray/rinses, pilocarpine and natural oil lip balm as per indication are used [25, 26]. All medical reviewers agreed.
Regarding the risk of osteonecrosis, DE6 and DE7 suggested it be lifelong. SOCP addresses the risk of osteoradionecrosis as it is considered to be lifelong [15, 16]. Also to make the care more inclusive, a broad term of osteonecrosis is used which included necrosis of bone, due to both chemotherapeutic agents and radiotherapy. In our protocol, extractions are avoided for the first-year post radiotherapy; no tooth is extracted even when indicated. This is done as there is maximum risk of ORN at this point. In these patients, pulpectomy followed by de-coronation of tooth is done. The roots are retained for this period and the patient is relieved of the pain. If the patient is able to maintain as such, these roots are retained, and if not, then extractions are done and the risk of ORN is explained. The risk of ORN does not decrease with time; hence, extractions are only done when absolutely necessary [13, 14].
For reinforcement and follow-up schedule, DE1 agreed with modification and suggested a 3 monthly follow-up for first-year post radiotherapy and 6 monthly thereafter for lifelong. ME3 suggested a joint clinic for better assessment. SOCP emphasises on the need of close follow-up, as dental disease burden pre-cancer treatment in our population is very high due to poor oral hygiene and oral care awareness. Also, the major modality of radiotherapy used in our patients is conventional radiotherapy which has higher post-treatment oral toxicities. Hence, a close follow-up is essential for oral care reinforcement and adequate quality of life.
In SOCP, there is a bi-annual x-ray for patients at high risk of osteonecrosis. Bite wings are very necessary to identify suspected proximal decay as this will not be seen in intraoral peri-apical x-rays. ME3 agreed with modification and suggested this could be patient specific. In SOCP, all x-rays are planned as per patient specific criteria and indication.
For radiation caries and prosthetic plan, DE11 agreed with modification and suggested fabrication of prosthesis 6 months post radiotherapy. In SOCP, prosthesis fabrication is done after sufficient soft tissue healing and resolution of xerostomia mostly which is around 6 months post radiotherapy. Interim obturators are fabricated as per standard protocol 1 to 2 months post radiotherapy and final obturator is given after completion of 6 months of tissue healing. A well-formulated final oral and maxillofacial prosthesis is essential for adequate aesthetics and function of the patient oral cavity.
Regarding fluoride regime, DE1 and DE11 agreed with modification, DE1 and DE11 suggested 6 monthly fluoride. In SOCP, professional fluoride application (~ 27,000 ppm) is done with fluoride varnish/gel once a month/3 months for a period of 1 year after completion of radiotherapy followed by 3 to 6 monthly application lifelong as per patient clinical status. Along with this is the use twice daily of fluorinated toothpaste (1000 ppm) and fluorinated mouthwash (200 ppm) as per need and assessment [19, 27]. This is done as part of fluoride program.
Limitation
Supportive care dentists who are involved as integral part of care in cancer patients at a cancer centre/hospital are limited in number. One of the challenges of the study was the small sample size of these professionals. There is lack of published organised oral protocol, scientific publications and data for our population. This leaves an uncharted area, which is a problem for supportive care dentist to follow. There is a need of an organised structure for supportive oral care for head and neck cancer patients. With this objective under consideration, the present study was undertaken with the intent to share a validated supportive oral care protocol with all the dentists involved in supportive care of cancer patients. The present protocol as a part of our study is currently being longitudinally observed for efficiency and clinical relevance for scientific documentation.
Conclusion
Our institutional supportive oral care protocol (SOCP) for head and neck cancer designed for dental experts working in a cancer care setting was proven valid. This protocol in our experience has improve quality of life in patients with head and neck cancer by decreasing the oral–dental side effects of cancer therapies.
We recommend this protocol to dentists involved in supportive care in head and neck cancer patient. We recommend a dedicated dental expert to be an integral part of cancer care team for providing a holistic and comprehensive treatment to head and neck cancer patients.
ANNEXURE :
Definition:
Supportive oral care: an umbrella term, which encompasses variety of procedures and interventions, needed to maintain a hygienic, functional and aesthetic oral cavity. It is for prevention, restoration and maintenance of distress caused by cancer therapies to oral soft tissues and hard tissues (oral mucosa, teeth and jaw bone). It is any oro-dental-related measure deemed necessary to reduce oral foci of infection. It aims at alleviating oral pain, decreasing acute and late-onset oral side effects of cancer therapies, providing oro-dental rehabilitation, addressing palliative dental pain management and improving quality of life in head and neck cancer patients.
| Level I care (starts at diagnosis of cancer) | |
|
Step 1. Initial referral and assessment |
This is the ideal stage for patient enrolment. All head and neck cancer patients receive a written referral by the treating oncologist for dental evaluation to supportive care dentist. Patients are assessed along with all necessary information including staging of tumour, surgical plan, plan of radiotherapy and/or chemotherapy. |
|
Step 2. Preparation and assessment phase |
a) Need and rationale for oral care is emphasised, information in regard to side effect of cancer therapies is explained. |
| b) Orthopantomogram x-ray taken for every patient; along with selected intraoral periapical x-rays. Assessment of dental disease burden is done by identifying teeth for filling (F), extraction (E) and root canal (R). | |
| c) Clinical assessment of gingival health, periodontal status and oral hygiene is made | |
| d). Assessment for mouth opening along with plan to manage trismus by jaw exercises is discussed if needed. | |
| e) Dental and oral prosthesis rehabilitation plan is discussed (e.g. for maxillectomy and hemimandibulectomy and others). | |
| f) Plan for surgical stent/obturators is made in case of carcinoma of maxilla, if needed. | |
| g) Plan for impression for radiation sparing oral appliance is made, if needed. | |
| h) Impression for mouth guard is made to prevent trauma to dental tissues during surgery, if needed. | |
| i) Completely edentulous patients are also enrolled for care of oral structures and future dental rehabilitation. | |
| j) Patients on neo-adjunct chemotherapy are assessed and assisted at every cycle for oral care. | |
| k) Patients who receive cancer therapies with palliative intent; only minimal dental intervention is done. All dental interventions are thereafter aimed to reduce microbial burden only. | |
| l) Patients are informed that extraction will not be done after completion of radiotherapy for a minimum duration of 1 to 1 and a half year due to increased risk of jaw necrosis, along with instructed for lifelong risk of osteo-radio necrosis. | |
|
Step 3. Dental treatment phase for patients receiving radiotherapy |
a) Oral prophylaxis (supragingival and subgingival), root planning, curettage, dental restorations and root canal treatment are completed. |
|
b) Extractions are done at least 7–10 days prior to radiotherapy. For patients with early stage of cancer 2–3 weeks of healing with minimal trauma and primary closure to promote faster healing. *For patients receiving only surgery as primary treatment, they are planned for all necessary dental treatments, either before, during or after oncosurgery. Most preferred for extraction is during the oncosurgery. These patients then directly enter into oral care maintenance phase with 3–6 monthly dental recall lifelong. *After healing of extracted sites, all the necessary impressions for obturators/ teeth guard/appliances as planned are done at this phase | |
| c) First appointment for Professional Fluoride application (varnish/gel) is done. Patient is informed about role and need of fluoride and gets enrolled in fluoride program. (sodium fluoride neutral gel, sustained-released sodium fluoride varnish.) | |
| d) Oral hygiene techniques (brushing and oral care) are shown to patients and then patients demonstrate it back to dental professional. | |
|
Step 4. Referring to radiotherapy |
a) After removal of all surgical sutures, adequate healing in oral cavity is assessed. (Enrolment in level I until completion of level I care is done within duration in 10 days; for patients in early stage of cancer, a period of 2–3 weeks is desired depending on patient profile.) |
| b) Patients reinforced with oral care techniques are referred back to radiation oncology to start radiation therapy. These patients now enter in level II care. | |
| Level II care (during chemo-radiotherapy)/parallel patient entry if not enrolled in level I | |
|
Step 1. Preparation for cancer therapy |
a) All necessary dental treatments are already done and patients are sent for radiation and/or chemotherapy treatment by supportive care dentist. This level starts from first day of radiation treatment and continues until 2 weeks after completion of radiation treatment. |
| b) Provision of parallel entry directly to level II care for patients who did not enrolled at level I care due to any reason whatsoever. | |
|
Step 2. Oral hygiene assessment during cancer therapy. |
a) All patients are seen once a week for the entire duration of radiation therapy. They are assessed for oral hygiene, oral mucositis, halitosis, candidiasis, xerostomia, change in saliva consistency and flow, trismus, burning sensation, swallowing difficulty and angular cheilitis. This assessment is done together with radiation oncologist weekly assessment during radiation treatment at joint clinic. |
| b) Patients are educated on how to brush during radiation treatment and maintenance of a good oral health. Use of an ultra-soft brush/sponge with small head (kid size) is advised. Patients are instructed to stop brushing when the ulceration/discomfort starts in oral cavity. For those who do not experience severe oral mucositis, continue brushing throughout the radiotherapy as per their comfort. | |
| c) Importance of use of antimicrobial rinse such as chlorhexidine is emphasised along with bland rinses such as sodium bicarbonate and salt. Importance of reducing oral microbial load and clearing of cell debris (desquamated epithelial cells) is emphasised. | |
| d) Oral care in patients with nasogastric tube is explained. | |
| e) Oral care in patients with oral-antral communication is explained. | |
| f) Care of denture is explained. | |
|
Step 3. Management of acute symptoms during radiation treatment and oral hygiene. |
a) Depending on the oral clinical findings, patient is advised proper oral care adjuncts. Topical analgesics (gel, ointment, viscous liquid, spray); antifungal ointments/tablets; anti-inflammatory agents (benzydamine); topical corticosteroids; xerostomia aids (spray, gargles); antimicrobial agents (chlorhexidine); bland rinses (salt and sodium bicarbonate); natural oil based lip care products. This phase is primarily done by radiation oncologist; supportive dentist is part of joint assessment and focuses on oral care and hygiene maintenance in this phase. |
| b) After 2–4-week visit post radiation treatment, patients are assessed and now patient enter into level III care. | |
| Level III care (after radiotherapy)/parallel patient entry for palliative care | |
|
Step 1. Oral assessment |
a) This is the tertiary level, which is the longest and deals with post-treatment rehabilitation and restoration of oral cavity functions. This lasts lifelong for patient. |
| b) Provision of parallel entry directly to level III care for patients who did not enrolled at level I and level II care due to any reason whatsoever. | |
| c) This phase deals with late side effects of chemotherapy and/or radiotherapy, including radiation decay, oral lesions, osteoradionecrosis (radiation/medicine induced), xerostomia and trismus | |
| d) Reinforcement for not undergoing extractions for a period of 1 to 1 and a half year post radiation is emphasised, explaining risk of jaw bone necrosis | |
| e) This starts soon after the completion of radiotherapy; patient is motivated and reinforced on oral care at every visit. This phase lasts for 1 year on monthly follow-up, and then 3–6 monthly lifelong follow-up, as per case. | |
| f) This level includes biannual OPG x-ray and selected IOPA x-ray along with bite wing x-ray, supra- and subgingival scaling, professional fluoride application (radiation caries), restoration of incipient lesion, xerostomia management, trismus management, osteoradionecrosis management and dental prosthetics and rehabilitation. | |
|
Step 2. Reinforcement and care |
a) Risk of radiation decay, jaw bone necrosis (radiation and medicine induced), is explained at every visit and reinforcement for oral care is done. This time is utilised to fabricate and deliver oral and dental prosthesis for patients as per prosthesis plan discussed in level I. |
| b) Professional fluoride application (~ 27,000 ppm) is done with fluoride varnish once a month/3 months for a period of 1 year after completion of radiotherapy followed by 3–6 monthly application lifelong, along with twice daily use of fluorinated toothpaste (1000 ppm) and fluorinated mouthwash (200 ppm) as per need and assessment. This is done as part of fluoride program. | |
| c) At the end of the first year of follow-up, patient is accessed and classified as good follow-up/poor follow-up and then is scheduled for 6 monthly/3 monthly oral check-up for lifelong (as per need). | |
| d) Patient is counselled about diet modification in respect to radiation caries (low sugar, high protein and fibre diet) | |
| e) Regular counselling and reinforcement is continued for tobacco and related product cessation. | |
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
Footnotes
Publisher’s Note
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