Oral health Oral Health
Conditions
Interventions
Interventions as of 25/09/2018:
In total, 2,288 participants will be recruited in order to retain 1,735 at 4 years.
This is a 4-year, multi-centre, parallel-group, ran
Sponsors
University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients 18 years of age or older who are dentate, have visited their dentist in the previous 2 years, and receive all or part of their dental care as an NHS patient.
Exclusion criteria
Exclusion criteria: Patients for whom periodontal probing is contraindicated or who have a medical condition indicating increased risk of bleeding (e.g., history of bacterial endocarditis, bleeding disorder, immuno-compromised).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures as of 25/09/2018: 1. Health related quality of life measured using an annual, self-administered patient questionnaire. Questionnaire will include a global assessment of quality of life using short form Oral Health Impact Profile, a standardised measure of health outcome (EQ-5D). After discussion and consideration a specially developed measure was not required. Removal of relevant text not done due to a clerical error. 2. Periodontal disease assessed by gingival inflammation/bleeding measured according to the Gingival Index of Loe. All clinical outcomes are measured at 4 years by trained examiners who are blinded to allocation. Current primary outcome measures as of 29/09/2011: 1. Health related quality of life measured using an annual, self-administered patient questionnaire. Questionnaire will include a global assessment of quality of life using short form Oral Health Impact Profile, a standardised measure of health outcome (EQ-5D) and a specially developed, context-specific, health related quality of life measure. 2. Periodontal disease assessed by gingival inflammation/bleeding measured according to the Gingival Index of Loe. All clinical outcomes are measured at 4 years by trained examiners who are blinded to allocation. Previous primary outcome measures included both current outcome measures plus the following point: 2. Caries experience assessed at both the enamel and dentine thresholds using the validated International Caries Detection and Assessment System (ICDAS). The ICDAS criteria measure both early and more advanced stages of caries. For early caries, ICDAS measures the surface changes and potential histological depth of carious lesions by relying on surface characteristics related to the optical properties of sound and demineralised enamel prior to cavitation. All surfaces of all tee | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 25/09/2018: 1. Caries experience assessed at both the enamel and dentine thresholds using the validated International Caries Detection and Assessment System (ICDAS). The ICDAS criteria measure both early and more advanced stages of caries. For early caries, ICDAS measures the surface changes and potential histological depth of carious lesions by relying on surface characteristics related to the optical properties of sound and demineralised enamel prior to cavitation. All surfaces of all teeth included will be examined and the status of each recorded in terms of caries. This system allows the recording of both preventive and operative care needs. 2. Plaque measured according to the Silness and Loe Plaque Index, calculus measured according to the Ramfjord Calculus Index and a colour-coded UNC periodontal probe will be used to measure periodontal pocket depth and clinical attachment level. The assessments will be made at 4 years by trained examiners who are blinded to allocation. After discussion it was decided that calculus would be recorded as present or not and that plaque and clinical attachment level would not be measured. This is reflected in the approved main trial protocol. 3. Patient-centred outcomes including dental anxiety, oral health related knowledge, attitudes, and behaviours, use of and reason for use of dental services (including symptoms and pain), and satisfaction with care measured using annual, self-administered questionnaire. Total duration of follow-up: 4 years. 4. Dentist attitude towards the different recall strategies measured using a self-administered questionnaire at month 0 and at 4 years Current secondary outcome measures as of 27/09/2011: 1. Caries experience assessed at both the enamel and dentine thresholds using the validated International Caries Detection and Assessment System (ICDAS). The ICDAS criteria m | — |
Countries
United Kingdom
Outcome results
None listed