Jönsson 2006.
Methods |
Trial design: parallel (2 arms) Location: Department of Periodontology, the County Council of Uppsala, Sweden Number of centres: 1 Study Duration: 3‐month follow‐up |
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Participants |
Participants: patients of the Department of Periodontology who demonstrated progress of disease and insufficient compliance at 1 year to 2 years review following initial periodontal therapy Inclusion criteria: individuals 20 years to 80 years of age with insufficient compliance (i.e. individuals who reported interdental cleaning (tooth picks or interdental brushes) less than 5 times a week combined with a dental plaque score > 0.20 according to Silness and Löe (Silness 1964)). To avoid missing the individuals who over‐reported their interdental cleaning, patients who reported interdental cleaning 5 times or more a week but nevertheless showed a dental plaque score > 0.40, were also included Exclusion criteria: not reported Age at baseline (years): intervention group: 54.8 ± 11.7 (25–74); control group: 58.1 ± 9.9 (41–78) Gender: intervention group: female/male, 9/10; control group: female/male, 8/8 Number randomised: 37 Number evaluated: 35 (intervention group: 19; control group: 16) |
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Interventions |
Intervention: Client Self‐Care Commitment Model (CSCCM) ‐ Visit 1. The first visit started with the initiation phase. The patient presented their own explanatory model of self‐care methods and disease processes, experiences of earlier treatments, and their beliefs about the reasons for disease progress. Thereafter, the last periodontal status was demonstrated, discussed, and compared with previous status. In the assessment phase, the dental hygienist (DH) used interview strategies with the help of an interview guide to disclose patient's perceptions of self‐care behaviours, knowledge of biomedical facts, and illness experiences. As an additional component of the commitment process, the DH provided the patient with the explanatory model of periodontitis. Depending on the patient responses, the DH provided further information if necessary. The negotiation phase started with the DH exploring the patients present oral hygiene status by using an Erytrosin‐based colouring disclosure agent (Rondell Red; Nordenta, Enköping, Sweden) after which appropriate dental cleaning aids were introduced. Thereafter, the DH and the patient discussed and negotiated with the purpose to achieve an improvement in oral hygiene. The DH assisted the patient to establish self‐selected goals in the commitment phase. A goal was established from the patient's individual requirements for toothbrush frequencies (i.e. how often and when during the day), interdental cleaning frequencies (i.e. how often and when during the week), and tooth surfaces of particular importance for cleaning. The patient made the decisions with the assisting of the DH. The result of the decision was documented in a written commitment containing: type of cleaning aid, frequencies and special areas. If there was enough time available at the first visit, scaling was performed ‐ Visit 2. At the next visit (after 1 week to 2 weeks) the client reported their compliance with the established self‐care commitment (evaluation phase). The oral hygiene status was checked by using an Erytrosin‐based colouring disclosure agent (Rondell Red; Nordenta, Enköping, Sweden) and new instructions and adjustments of technique were discussed if necessary. If the clients had new requirements for the commitment, adjustments were made. Necessary scaling and polishing were provided ‐ Visit 3. Approximately 4 weeks after baseline and the written commitment. The aim with the visit was to check if the patients had found the self‐selected goals realistic and if any changes were necessary. No other treatment was performed ‐ Visit 4. The final evaluation was performed 12 weeks to 14 weeks after the first visit. The patients were given the second questionnaire.The same dentist performed the same clinical assessments as at baseline. The data from the clinical assessments were analysed and discussed with the patient. The commitment was also evaluated and adjusted if necessary. Finally, the recall intervals were discussed and established Control: ‐ Visit 1. The latest periodontal status was demonstrated, discussed and compared with previous status. New information about the periodontal disease was given if necessary. The oral hygiene instructions was performed, controlled and adjusted if necessary, by using a colouring disclosure agent (diaplaque Oral Pharma). Necessary scaling and polishing were provided ‐ Visit 2. At the next visit (after 1 week to 2 weeks), the oral hygiene status was checked by using a colouring disclosure agent (diaplaque Oral Pharma) and new instructions and adjustments of technique were discussed if necessary. Necessary scaling and polishing were provided ‐ Visit 3. The final evaluation was performed 12 weeks to 14 weeks after the first visit. The patients were given the second questionnaire. The same dentist performed the same clinical assessments as at baseline. The data from the clinical assessments were analysed and discussed with the patient. Finally, the recall intervals were discussed and established Prophylaxis provided: necessary scaling and polishing were provided at the first visit for the control group and where time allowed for the intervention group, and for both groups at the second visit Member of dental team delivering intervention: hygienist Frequency of intervention: intervention group: 4 visits total, 3 visits with OHA; control group: 3 visits, with 2 visits with OHA Intensity of intervention (length of time): intervention group: not reported; control group: not reported Setting: secondary care Disease level: patients of the Department of Periodontology who demonstrated progress of disease and insufficient compliance at 1 year to 2 years review following initial periodontal therapy |
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Outcomes |
The clinical examination: consisted of plaque index (PI) according to Löe 1967, gingival index (GI) according to Löe 1967, probing pocket depth (PD) measuring 6 sites (mesio‐, mid‐, disto‐buccal, and mesio‐, mid‐, disto‐lingual) per tooth, and bleeding on probing recorded on 4 sites as absent or present and summarized as a percentage index for all teeth Participant reported: all participants were given a questionnaire at baseline and at the end of the study. The questionnaire covered oral self‐care habits such as frequency of toothbrushing and interdental cleaning, type of interdental cleaning aid, time spent and reasons for cleaning the teeth and finally demographic data. At the end of the study, there were additional questions regarding possible change in their oral self‐care |
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Notes |
Funding: not reported Sample size calculation: not reported Adverse effects: not reported Declarations/conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomization was organized by giving the 10 individuals a number. By using a lottery, the first 5 numbers were included to the intervention group and the rest to the control group" |
Allocation concealment (selection bias) | Unclear risk | Quote: "The randomization was organized by giving the 10 individuals a number. By using a lottery, the first 5 numbers were included to the intervention group and the rest to the control group" Comment: insufficient information on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "37 individuals, were included in a randomized single‐blind control trial to test an intervention based on the CSCCM" Comment: study reported as single‐blind trial and that the outcome assessor was blinded to allocation. 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 clinical assessments were performed at baseline and at the final evaluation by the same examiner, an experienced periodontist (NO) who was blind to the group allocation" Comment: study reported as single‐blind trial and that the outcome assessor was blinded to allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "2 of the patients dropped out; 1 became ill, and 1 declined treatment at the clinic for Periodontology" Comment: unclear which group these dropped out from. Given low numbers unlikely to introduce bias |
Selective reporting (reporting bias) | Unclear risk | Quote: "All participants were given a questionnaire at baseline and at the end of the study. The questionnaire covered oral self‐care habits such as frequency of toothbrushing and interdental cleaning, type of interdental cleaning aid, time spent and reasons for cleaning the teeth and finally demographic data. At the end of the study, there were additional questions regarding possible change in their oral self‐care. For the intervention group, the questionnaire also included questions if the written commitment had any influence on their oral self‐care habits" Comment: not all questionnaire data presented |
Other bias | Low risk | No apparent other bias |