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. 2020 May 4;10(3):266–275. doi: 10.1016/j.jobcr.2020.04.009

Retrospective study of treatment outcomes with implant retained auricular prostheses at a tertiary referral care centre

Gunjan Pruthi 1,1, Kirti Bansal 1,2, Veena Jain 1,∗, Dheeraj Kumar Koli 1
PMCID: PMC7264717  PMID: 32509517

Abstract

Purpose

To discuss the indications, technical steps for fabrication of implant retained auricular prosthesis (IRAP), and treatment outcome at various follow up visits.

Materials and methods

We performed retrospective data collection of all consecutively treated patients referred to us for auricular reconstruction from 2006 till 2018. Each case was analysed for: feasibility of autogenous reconstruction vs IRAP, surgical procedure, type of anaesthesia, type of implants, soft tissue response, implant success and survival rate, prosthetic attachment, aesthetic outcome, complications and patient acceptance. Procedure for fabrication of IRAP has also been written in detail to benefit readers.

Results

IRAP was considered feasible and performed in eight out of 27 patients referred for auricular reconstruction. 20 implants were placed and total 10 prostheses were fabricated. Implant success rate and survival rate was 90% and 100% respectively till last follow-up of each patient. Bar and clip attachments were used in 60% and stud attachments in 40% of prostheses. After stage II surgery, grade I soft tissue inflammation was reported around two implants (10%), and grade III around one implant (5%). Implant with grade III inflammation showed features of recurrent infection and thus was left buried under soft tissues. These prostheses were aesthetically pleasing in all cases in the early post-operative period.

Conclusions

A systematic, step wise procedure with multi-disciplinary approach is a key to success for the fabrication of implant retained auricular prosthesis.

Keywords: Craniofacial implant, Auricular prosthesis, Quality of life, Silicone

1. Introduction

Auricular defects can be congenital or acquired in origin. Congenital deformity of external ear is termed as Microtia.1 Patients with various syndromes or isolated genetic anomaly may present with unilateral or bilateral microtia. Studies on difference populations have documented higher prevalence of unilateral presentation of microtia over bilateral and male predominance over females.2,3 Acquired auricular defects may occur during child birth by forceps application, some rare but fulminant fungal infections, neoplasms, trauma or burns.4

Microtia can be rehabilitated either via autogenous reconstruction or by osseointegrated prosthetic reconstruction. Autogenous reconstruction using patient's own body part has the main advantage of having feeling of self-body part and requires little or no post treatment maintenance. However, there are certain limitations of autogenous reconstruction such as, non-availability of donor tissue, involvement of multiple surgeries, chances of recurrence in case of neoplasms, unhealthy underlying tissues, and contraction of tissues secondary to burn injury.5 Also, the final reconstructed ear may not be exactly similar to the anatomy of the contralateral ear.

Prosthetically reconstructed ear has better aesthetics as sculpting and colour matching is done in accordance with rest of the facial tissues. Total treatment duration is also lesser with this modality as it is generally a two staged procedure (with a gap of 3–6 months between stage 1 and stage 2 surgery) while multiple surgeries are required to achieve desired results with autogenous reconstruction. But the main drawback is that the prosthesis needs to be removed during night or water sports activity, requires daily cleaning of implant site and there occurs the need of re-fabrication of prosthesis after 1.5–2 years due to discoloration or loss of marginal adaptation with time.6

With the advent of medical grade silicones and osseointegrated implants, there has been an increase in the aesthetic and functional value of these prostheses in the recent years Historically, several materials were used to fabricate these prostheses like silver mask, vulcanite rubber, latex, acrylic resin, polyurethane, polysiloxane etc.7 Heat cure acrylic resin and room temperature vulcanization (RTV) silicone are being used most commonly these days. Main advantage of heat cure acrylic resin is its easy availability, low cost and good tear and marginal strength. Major limitations are its monotonous appearance and difficulty in reproduction of ultra-thin margins.8 On the other hand, RTV silicone provides a more lifelike appearance, and margins of the prostheses can be made ultra-thin.

Different types of retentive aids are being used to retain extraoral facial prosthesis. Earlier spectacle or adhesives9,10 were used very commonly but spectacles do not serve well in the cases of missing auricle. Adhesives also do not provide effective retention due to presence of the sebaceous glands in auricular region and movement of soft tissue along with mandibular movements. Other problems encountered with adhesive is difficulty in orientation of the prosthesis due to unpredictable landmarks over altered facial contour and risk of marginal tear with repeated application and removal of adhesive.11, 12, 13 Osseointegrated implants can be used to anchor auricular prosthesis with the help of various attachments like bar and clip, magnets, ball attachments etc. In comparison to other retentive modes, IRAP provides several advantages i.e. convenience of orientation, consistent retention, positioning, and maintenance of marginal integrity and longevity.14, 15, 16, 17

No Indian data on IRAP could be found in recent literature with long term follow up. So, the aim of this article is to discuss the various clinical steps followed during fabrication of implant retained auricular prosthesis (IRAP) on case to case basis; to discuss the implant survival/success rate and complications encountered on the basis of our clinical experience from year 2006 till 2018.

2. Methodology

2.1. Patients’ distribution

This clinical evaluation included 27 patients (14 males and 13 females) with auricular defects who reported to our tertiary care centre between years 2006–2018 for rehabilitation. All the patients were explained in detail about the procedure, benefits and limitations of surgical versus prosthetic reconstruction of the ear. Out of these 27 patients, eight patients were rehabilitated via prosthetic approach while rest 19 patients opted for autogeneous reconstruction and were referred to concerned department for further management (Flowchart 1).

Out of 8 patients who received implant retained auricular prosthesis, two patients had bilateral microtia and remaining six patients had unilateral microtia; so, total 10 IRAP were fabricated after using 18 out of 20 implants placed. Details are presented in Table 1.

Table 1.

Patients’ details.

Patient No. Age/Gender Aetiology Clinical presentation No of implants inserted No of implants used Implant system
Used		 Type of Attachment used Total Follow up (years)
1 a18/M Congenital Bilateral 4 4 Endopore Hader Bar and clip 1
2 20/M Congenital Bilateral defect 4 4 Endopore (Innova, Ontario, Canada) Hader Bar and clip 11
3 24/M Congenital Unilateral 2 1 Endopore Dellabona 10
4 22/F Congenital Unilateral 2 1 Endopore Dellabona attachment 10
5 28/M Congenital Unilateral 2 2 Leader Tixos, Italy Bar and clip 7
6 23/F Congenital Unilateral 2 2 Leader, Tixos, Italy Ball attachments 7
7 27/M Trauma Unilateral 2 2 Leader, Tixos, Italy Bar and clip 6
8 22/F Trauma Unilateral 2 2 Osstem, Korea Ball attachments 5
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Total number of implants inserted = 20.

Total number of implants used = 18.

a

He discontinued using prosthesis after one year of use and reported to get the bar removed. Implants were left submerged under tissue.

2.2. Diagnosis and treatment planning (flow chart 2)

Clinical examination of bone and associated soft tissue was followed by fabrication of facial moulage (following landmarks given by Tolleth18) for the diagnostic wax up to evaluate the 3D orientation of the prosthesis (Fig. 1a, Fig. 1ba and b). Wax prototype was duplicated in self cure acrylic resin (DPI RR, cold cure, India) and two radio opaque markers were placed at the proposed implant locations to obtain a radiographic stent. Keeping this stent in position, CT (computed tomography) scan was performed. Later on, these radiographic stents were converted into surgical stents by drilling holes at the place of radio opaque markers or adjacent to markers if any change in position was required.

Fig. 1a.

Fig. 1a

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Landmarks marked on patients face before impression.

Fig. 1b.

Fig. 1b

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Diagnostic models with landmarks transferred.

In one patient (Patient 8), auricular pattern generation was done using “mimics” image processing software and mirror image of contralateral ear. It was 3D printed in Acrylonitrile Butadiene Styrene (ABS) and subsequently a mould was formed using putty consistency of addition silicone. Molten wax poured in it to get the wax pattern which was tried on the patient's face (Fig. 2a–c).

Fig. 2.

Fig. 2

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a–2c: Duplication of 3D printed pattern to fabricate wax pattern.

2.3. Surgical considerations

The main characteristic of facial bones is that they are thin and broad. Thus, for craniofacial prosthesis, Sir Branemark designed shorter (2–4 mm in length) and wider (4–5 mm) diameter screw titanium implants.19 We used implants available for intraoral rehabilitation for fabrication of auricular prosthesis (Table 2).

Table 2.

Implant characteristics.

Implant (company) Total number of implants inserted Hex design Surface texture Collar Size Insertion technique
EndoporeR 12 External hex - 4
Internal hex - 8		 Porous sintered Polished 5*5 mm Tapping
Leader (Tixos short) 6 Internal hex Biological organic acid treatment Polished 5*5 Self-screw in
Osstem (TS III SA ultrawide) 2 Internal hex SLA Coated 5*6 Self-screw in
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Total of 20 implants (two implants per ear) were placed in collaboration with Otorhinolaryngologist using standard surgical procedure under general anaesthesia in initial two cases, while in later cases local anaesthesia was used.

During surgery, surgical stent was placed in position and a bio-compatible skin penetrating dye was injected in the holes so as to transfer the virtual implant positions on the bone surface. Full thickness flap was reflected in the vicinity of dye marks. Implant drill tools were used according to the type and size of implant (Fig. 3a). Primary stability was achieved and implants were left submerged during healing phase. Removal of remnant tissue, flap debulking or soft tissue thinning was also performed in most of the cases at the time of implant placement. All the patients were kept on systemic antibiotics and analgesics for seven days.

Fig. 3a.

Fig. 3a

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Post Implant placement.

3. Second stage surgery

Lateral cephalogram or anteroposterior (A-P) view of face was taken 5–6 months after first stage surgery to assess the osseointegration of implants (Fig. 3b). Second stage surgery was accomplished under local anaesthesia in all the cases and implant/abutment level secondary healing screws were tightened (Fig. 3c).

Fig. 3b.

Fig. 3b

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Post implant radiograph.

Fig. 3c.

Fig. 3c

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Implants exposed and secondary healing caps placed.

4. Prosthetic considerations

4.1. Abutment selection

Multi-unit abutments (UMA - universal modified abutment) were used in most of the cases. UMA has transmucosal attachment (TMA) in titanium. This trans-mucosal attachment serves as part of implant. Therefore, repetitive trauma to soft tissue during the insertion and removal of the abutment can be avoided. Height and angulation of the transmucosal part was chosen according to the thickness of the soft tissue and angulations of the implants. Its height was selected so that TMA remains slightly above or at the level of skin. Instead of UMA, UCLA abutment can also be used for the casting of bar framework in titanium.

4.2. Attachment selection

For the retention of auricular prosthesis, splinted (Bar with clips) or non-splinted attachments (Ball/Dallabona) were used. Selection of type of attachment was based on number, position and angulation of the implants.

4.3. Prosthetic procedure

4.3.1. Fabrication of sub structure/acrylic conformer

Standard procedure for recording the impression and fabrication of model with implant analogues was followed (Fig. 4a, Fig. 4ba and b). For cases where locator or ball attachments were selected to retain the prosthesis, attachments were directly engaged on the implant/abutment analogues over model and acrylic sub structure for auricular prosthesis was fabricated.

Fig. 4a.

Fig. 4a

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Splinting of impression posts.

Fig. 4b.

Fig. 4b

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Final impression.

Pattern for bar and clip was made on working model and it was casted in titanium (Fig. 5a, Fig. 5ba and b). After trial on patient's face, model with casted bar was duplicated in dental stone. Relief wax was adapted around the implants/abutment analogues before duplication of model to provide space under the sub structure and to maintain the air flow and health of underlying tissue. Clips were positioned over the bar; area under the bar and on the side of the clips were blocked out using undercut blockout wax except the most terminal areas (0.5–1mm) of the bar where it acted as anti-rotational feature for future acrylic conformer. Later on, these clips were removed from the bar. This cast was duplicated using irreversible hydrocolloid (Imprint, DPI, India). Clips were seated over the duplicated bar and wax up was done for the fabrication of acrylic conformer (Fig. 6a, Fig. 6ba and b). Holes were made in the conformer to aid in the mechanical retention of silicone material.

Fig. 5a.

Fig. 5a

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Pattern for Hader bar and clip attachment.

Fig. 5b.

Fig. 5b

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Trial of bar and clips on patient's face.

Fig. 6a.

Fig. 6a

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Pattern for fabrication of acrylic conformer.

Fig. 6b.

Fig. 6b

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Trial of conformer on patient's face.

Pattern for the auricle was sculpted in wax over this acrylic conformer and checked onto patient's face for its dimensions, fit, aesthetics and position.

4.3.2. Functional impression

Functional impression was made to decrease the chances of marginal discrepancy at border areas. Patient was seated in upright position and the intaglio surface of wax trial prosthesis was scraped at the borders to make space for impression material. Ultra-light body addition silicone impression material (Aquasil ultra-light body, Dentsply India Ltd) was flown over the border areas of the pattern and it was placed in position over the attachments. Patient was instructed to make various facial movements like swallowing, opening and closing of the mouth. Impression was retrieved and altered cast technique was used to pour the functional impression and final model was obtained in type III Gypsum.

4.3.3. Marginal adaptation and texturing of the pattern

Impression material was removed and model was scored at the border areas of wax prototype to enhance marginal adaptation. Texturing of the pattern was performed using warm gauze piece to simulate the skin creases.

4.3.4. Lab procedure and delivery of final prosthesis

A 3-piece mould was made in Gypsum and de-waxing was done (Fig. 7). RTV silicone (factor II, INC, USA) was mixed in small mixtures to match its variability as per skin tone of the ear. Primer was applied on acrylic conformer to enhance the bond between acrylic and silicone. After curing of silicone, prosthesis was retrieved carefully and moulds were preserved. Final prosthesis was checked on each patent's face for any need of extrinsic staining. Required modifications were made and final prosthesis was delivered to the patient. (Fig. 8a–d). Patients were educated to handle the prosthesis gently with clean hands, to clean the prosthesis with normal soap solution regularly and to remove it during bed time, bathing and water sports.

Fig. 7.

Fig. 7

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3-piece mould.

Fig. 8.

Fig. 8

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a–8d: Final prostheses.

4.4. Follow ups

Patients were recalled on day 3, 7 and subsequently at 6 months and yearly follow up. At each follow up, patients were assessed for soft tissue response (Holger's et al.9 criteria), implant health, any prosthetic complications e.g. acrylic sub structure fracture; screw loosening; screw fracture; retentive component replacement, marginal adaptation/tear of the prosthesis; silicone discoloration and clinical acceptance of the prosthesis (Table 3).

Table 3.

Soft tissue response (Holger's criteria).

Patient
Number		 Holger's grade of Inflammation (After second stage) Intervention Holger's grade of Inflammation (After prosthesis delivery) Intervention Holger's grade of Inflammation
On Subsequent follow ups
Pt. 1 0 – 0 – 0
Pt. 2 1 Ointment Betadine local application wait and watch
Good prognosis		 0 – 0
Pt 3 3 Curettage and wait and watch.
Good prognosis		 3 Curettage, wait and watch
Poor prognosis
One implant was not used later on.		 0
Pt 4 0 – 0 – 0
Pt 5 0 – 0 – 0
Pt 6 2 Local application of Betadine ointment, wait and watch
Good prognosis		 0 – 0
Pt 7 0 – 0 – 0
Pt 8 0 – 0 – 0
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Holger's crietaria5 of soft tissue inflammation.

Grade 0- no irritation, Grade 1- slight redness; Grade 2- red and slight moist; Grade 3- granulation tissue and red moist; Grade 4- infection.

5. Observations

Out of 27 patients who reported to us for auricular reconstruction, 19 (70.37%) opted for autogenous reconstruction while only eight (29.63%) patients opted for implant retained auricular prosthesis. Out of these eight patients, in 6 (75%) cases, autogenous reconstruction was not feasible due to severe tissue contracture secondary to canaloplasty or trauma while two patients themselves opted for prosthetic reconstruction because of the fear of undergoing multiple surgeries required for autogenous reconstruction.

Six patients (75%) were young males with an average age of 23 years. Six patients (75%) had history of congenitally missing auricle out of which one case had diagnosed Pierre robin syndrome and 2 patients had (25%) had history of trauma, both of them were females (Table 1, Table 2).

Splinted attachments (Hader bar and clip) were used to retain six prostheses; Dallabona attachments were used to retain 2 prostheses in which single implant could be used while ball attachments were used to retain 2 prostheses. Various clinical findings noted were as follows:

5.1. Surgical complication

All surgeries were uneventful except in one case where drill inadvertently slipped inside the air cells during osteotomy and thus, that site was abandoned and left sealed with bone wax. Another site was chosen at the same time and implant was placed (Patient 2/Fig. 9).

Fig. 9.

Fig. 9

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Sequential steps for patient with surgical complication and prosthesis fabrication using single implant.

5.2. Implant survival/success rate

Total 20 implants were placed in the mastoid region with 100% survival rate at minimum 5 years and maximum up to 12 years follow up in different patients. Implant survival rate was not influenced by implant design i.e. surface design, hex design, collar design, and implant size. The success rate was 90% as only 18 implants could be actually used for fabrication of prosthesis over them (table no 1). One caudal implant was placed at location far from planned dimensions of prosthesis and one implant in another case showed persistent soft tissue inflammation. So, these were left as sleeping implants.

5.3. Soft tissue inflammation

As per Holger's criterion, Grade 1 soft tissue inflammation was noted around transmucosal abutments over two implants and grade III inflammation was noted around transmucosal abutment of one implant after stage II surgery (Table 3). Grade –I inflammation subsided after betadine ointment application; grade 3 inflammation subsided after curettage and betadine ointment application. Later on, the implant with grade 3 inflammation around abutment showed recurrence of infection. Hence, it was left buried under soft tissues (Fig. 10a and b). In all cases, inflammation was associated with caudal implants but no specific reason could be made out for this.

Fig. 10.

Fig. 10

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a: Inflammation around caudal abutment. b: Caudal implant left buried under soft tissue. 10cConformer over single attachment. d: Final prosthesis using single implant/attachment.

5.4. Clinical outcome

During the observation period, none of the patients reported with implant or prosthetic failures like bar fracture, screw loosening, fracture of acrylic sub structure or bond failure between acrylic sub structure and silicone. Clip loosening was reported in patients with bar and clip type of attachment. Clips were tightened/replaced as and when required. (Table 4).

Table 4.

Complications at Follow up visits.

Follow up visits No. Of reported cases
1. Implant failure 0
2. Bar fracture 0
3. Sub structure fracture 0
4. Bond failure between sub structure and silicone 0
5. Poor compliance 1
6. Discoloration of prosthesis 7
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Prosthesis replacement was done in 7 patients showing average life span of 2.5 years (i.e. repacking of silicon in preserved mould) because of discoloration of silicone or due to discoloration along with loss of marginal adaptation. Clinical acceptance was found to be 87.5%. Despite of varied clinical outcome, patient's compliance was good for the prosthesis.

6. Discussion

This retrospective analysis was done to evaluate long term clinical performance of implant retained auricular prosthesis.

One of the main considerations in planning a case of missing auricle is to choose between autogenous vs prosthetic reconstruction. We have to take into consideration various factors like age of patient, feasibility of achieving good aesthetic outcome, patient's compliance and availability for follow up. In our experience only 29.62% patients opted for prosthetic reconstruction and in most of these cases, autogenous reconstruction was not possible. In one case, patient himself preferred the prosthetic reconstruction over autogenous reconstruction, but later on even after good aesthetic results, he did not accept the prosthesis because he was unable to perceive it as his own body part. Therefore, younger patients should always be encouraged for autogenous reconstruction and prosthetic approach should only be used when the former is not feasible or is not able to produce desired results.

Analysis of the treated cases emphasizes the importance of using diagnostic aids and detailed treatment planning to achieve the desired position and angulation of implants and hence good aesthetic results. We have used both conventional and manual methods for fabrication of auricular prosthesis at all steps except in one case where 3D pattern was generated using “mimics” software. Many authors have reported the use of different digital softwares, 3D printers and materials for data acquisition and pattern generation.20, 21, 22, 23, 24 Spectromatch colour system was also used by few clinicians to produce better colour match.20,22 Use of advanced digital technology is a promising step ahead and definitely is the future, as it saves time and gives improved aesthetic outcome; factors like restricted accessibility, expertise, availability of software, and the cost involved still offer a hindrance for using them in each and every case.

As per our experience, 100% survival rate of the implants was observed irrespective of patient and implant characteristics. At our centre implants available for intraoral use were used for placement in mastoid region also because of lesser availability and high cost of extra oral implants. Visser et al.6 had recommended intraoral implants for fabrication of auricular prosthesis as extraoral implants are machined and they lack special surface treatment. Intraoral implants were used by Karakoca et al. in nasal region.24

A high survival rate of implants placed in mastoid region has also been reported by other authors.25, 26, 27, 28, 29 Mastoid region consists of a highly dense cortical bone.30,31 Availability of bone height is less in this region due to the presence of mastoid air cells and sigmoid sinus. Therefore, shorter length implants with wider diameter were used to compensate for its functional surface area. Implants are subjected to approximately 0.1–1 N of static forces due to the weight of auricular prosthesis (as compared to intraoral implants which are subjected to 50–200 N).32 So, shorter implants can be placed in mastoid region.

Placement of implants can be done under general or local anaesthesia depending upon general systemic health of the patient, compliance of patient; extent of soft tissue modification requirement, patient's consent and availability for hospitalization or added cost and operator's choice. We performed two surgeries under general anaesthesia as in first patient lot of remnant tissue had to be removed and second patient had to undergo palatoplasty simultaneously. It was observed that procedures performed under local anaesthesia provided faster post-operative recovery.

Selection of an appropriate attachment is also one of the key factors for overall success of the prosthesis. Bar and clips provide uniform distribution of stresses while in case of isolated attachments, each implant may be subjected to increased amount of stresses during placement and removal of the prosthesis.24,33 However, hygiene maintenance around and beneath the bar requires little more efforts as compared to isolated attachments to prevent any peri implantitis. In our experience, cases where only single implant with Dallabona attachment was used to retain the prosthesis, showed no problem so far with respect to implant failure or prosthesis retention. However, as per literature two implants should be placed in mastoid region for implant retained auricular prosthesis.32

Soft tissue inflammation was noted either after stage II surgery or at the time of delivery of final prosthesis. Soft tissue inflammation in these cases may be attributed to excessive soft tissue thickness, sebaceous glands in adjacent area or lack of local hygiene. Other reasons like implant design or the technique of its insertion etc. were ruled out because inflammation was present around one implant only. Few other authors have described hygiene as the most important factor in maintaining peri implant tissue health.9,34 Abu-Serriah et al. reported that the skin reactions tended to occur due to penetrating alloplastic material in the first 2 years following completion of implant-retained prosthetic rehabilitation.35

Most of the patients underwent silicone discoloration with time. Visser et al.6 observed discoloration as cause of fabrication of new auricular prosthesis in 31.2% of cases. This may be because of the colour degradation in silicone in temperate climates, artificial aging, and ultraviolet light exposure.36, 37, 38, 39 Moreover, extraoral prostheses are exposed to mucosa and skin secretions; subsequently, multilayer biofilm formation can occur on the silicone surfaces. Biofilm layers can harbour microorganisms within the pores of silicone; these microorganisms cannot be removed by washing the prostheses. Problems such as black stains on the surface of prostheses, offensive odours, and tissue infection can arise from microbial colonization.6,35

7. Conclusions

Implants provide successful rehabilitation of patients with missing auricle. Implant retained auricular prosthesis should only be considered where surgical reconstruction is not possible. Systematic step wise procedure with multi-disciplinary approach is a key to success for the fabrication of implant retained auricular prosthesis.

8. Limitations

This article has reported data of only 8 patients, based on observations at one tertiary care centre. Multicentre studies are recommended to obtain more scientific analysis of success and survival rates of implants placed in mastoid region and associated complications.

Declaration of competing interest

The authors have none to declare.

Acknowledgements

Authors acknowledge the resident doctors of Dept. of Prosthodontics, CDER, AIIMS, who worked hard for fabrication of implant retained auricular prostheses and patients who were compliant enough for their frequent visits from distant places.

Contributor Information

Gunjan Pruthi, Email: gunjan_prostho@yahoo.co.in.

Kirti Bansal, Email: kirtisays2u@gmail.com.

Veena Jain, Email: jainveena1@gmail.com.

Dheeraj Kumar Koli, Email: dr.dheerajkoli@gmail.com.

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