López‐Jornet 2014.
Methods |
Trial design: parallel (2 arms) Location: Department of Oral Medicine, Murcia University Dental School, Murcia, Spain Number of centres: 1 Study duration: 8‐week follow‐up of patients attending during 2009 and 2010 |
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Participants |
Participants: patients with hyposalivation attending the Department of Oral Medicine Inclusion criteria: "..patients complaining of dry mouth as assessed by a response of 30 mm or greater on at least 1 of 8 Dry Mouth Visual Analogue Scale (VAS) questions; subjects with an unstimulated whole salivary flow rate of less than 1.5 mL/15 minutes; patients who had never received periodontal treatment or been taught the brushing technique; and patients who were considered sufficiently fit in terms of physical capacity to implement hygiene measures" Exclusion criteria: "..patients younger than 18 years; patients with insufficient manual dexterity; edentulous patients; and subjects with an uncontrolled medical condition that might require changes in medication during the course of the study" Age (years): 56.7 ± 15.4 (range, 31 years to 84 years old) Gender: overall: female: 48 (80%), male: 12 (20%); intervention group: 22 (73%) females and 8 (27%) males; control group: 26 (87%) females and 4 (13%) males Number randomised: 60 (intervention group: 30; control group: 30) Number evaluated: 60 (intervention group: 30; control group: 30) |
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Interventions | Quote: "In both groups, oral hygiene instruction was given once every 15 days with a total of 4 sessions over the 8‐week period" Intervention: advice on conventional hygiene procedures using a motivational–behavioural skills protocol designed following principles of self‐efficacy theory, which required a longer time. This was a systematic method, consisting of 6 steps designed to help patients make effective lifestyle changes and to identify and resolve problems. It consisted of the following steps: step 1: creating confidence and commitment; step 2: increasing self‐awareness of behaviour; step 3: developing and implementing an action plan; step 4: evaluating the plan; step 5: maintaining change; and step 6: preventing relapse (Kakudate 2009) Control: instruction in conventional hygiene procedures for 20 minutes based on the Bass method of oral health education (Quigley 1962) Prophylaxis provided: not reported Member of dental team delivering intervention: dental care professional Frequency of intervention: intervention group: 4 visits with OHA; intervention group: 4 visits with OHA Intensity of intervention (length of time): intervention group: quote "which required a longer time;" control group: 20 minutes Setting: secondary care Disease level: dry mouth with no history of periodontal treatment |
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Outcomes | Quotes: "On the first visit, patient data were registered (age, gender, medical history, disease process, drug history, family history and clinical signs and symptoms), and then plaque extension index, bleeding index and CPITN were measured," "the periodontal health of all patients was assessed on the first visit and at the end of the oral hygiene instruction programme," "all patients were subjected to a periodontal clinical examination performed at 6 sites per tooth (excluding third molars) to determine the plaque extension index (PEI) following plaque disclosure using a 2% aqueous erythrosine solution. A cotton swab was submerged in the solution for 10 seconds and was then applied to the tooth surfaces. After rinsing once with water, plaque deposits were assessed using the Quigley and Hein index, modified by Turesky et al, with scores from 0 to 5. Periodontal condition was assessed by means of the World Health Organization (WHO) Community Periodontal Index of Treatment Needs (CPITN), using the specially designed WHO periodontal probe (23/CP11, Hu‐Friedy, Leimen, Germany) with a sensing force of no more than 20 g. Each patient's mouth was divided into sextants, and each sextant was examined providing that there were ≥ 2 teeth present and that these were not indicated for extraction. The teeth examined were 1.7, 1.6, 1.1, 2.1, 2.6, 2.7, 4.7, 4.6, 4.1, 3.1, 3.6, and 3.7. The highest index found in each sextant was recorded according to the following scores: 0 = good periodontal health; 1 = gingival bleeding; 2 = calculus detected during probing; 3 = pocket 4 mm to 5 mm in depth; and 4 = pocket ≥ 6 mm in depth. The periodontal condition of each patient was reported as the worst sextant CPITN score" | |
Notes |
Funding: not reported Sample size calculation: not reported Adverse effects: not reported Declarations/conflicts of interest: not reported Additional information from author correspondence: "..intervention was provided in a dental clinic setting....The advice were (made) by dental care professional" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned to 2 groups – control group and intervention group – by a single researcher using a random numbers table" |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "In both groups, oral hygiene instruction was given once every 15 days with a total of 4 sessions over the 8‐week period" Comment: blinding of participants was not possible; it is unclear the influence this would have on the risk of bias for this domain |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The same examiner (CRA), blinded to group assignment, performed all clinical measurements throughout the study" Comment: the examiner did not know which group the participants they were assessing had been assigned to |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing outcome data, all participants followed‐up |
Selective reporting (reporting bias) | Low risk | All outcomes in methods section were reported |
Other bias | Low risk | No apparent other bias |