About this trial
Periodontitis is a chronic inflammatory disease in which long-term treatment success depends greatly on patients' adherence to oral hygiene practices and periodontal therapy. Psychological factors such as oral hygiene-related self-efficacy and illness perception may influence patients' motivation and ability to maintain effective plaque control and attend follow-up visits. However, limited evidence exists regarding the impact of behavioural interventions on adherence and clinical outcomes in periodontal therapy.
This randomized controlled trial aims to evaluate the effect of an behavioural intervention on treatment adherence and clinical periodontal outcomes in patients with Stage I-III periodontitis having low oral hygiene-related self-efficacy. A total of 78 participants will be randomized into test and control groups. Both groups will receive Step 1 and 2 periodontal therapy, including professional mechanical plaque removal and risk factor control. The test group will additionally receive a self-efficacy-based behavioural intervention while the control group will receive conventional oral hygiene instructions.
Clinical periodontal parameters including Turesky modification of Quigley-Hein Plaque Index (TQHI), Full Mouth Bleeding Score (FMBS), probing pocket depth (PPD), and clinical attachment level (CAL) will be assessed at baseline, 8 weeks, and 6 months. Oral hygiene self-efficacy and illness perception will also be evaluated using validated questionnaires. The primary outcomes will be treatment adherence and treatment response at 6 months. The study aims to determine whether a self-efficacy-based behavioural approach can improve adherence and enhance periodontal treatment outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Inclusion criteria at the patient level, age ≥ 18 years
According to the 2017 EFP/AAP classification, patients with periodontitis stage I-III, with low self-efficacy will be included
According to American Society of Anaesthesiologists Physical Status classification P1 and P2 will be included.
Disqualifiers
Patients will be excluded from the study if they have any of the following characteristics
According to American Society of Anesthesiologists Physical Status classification P3 and P4 will be excluded.
Use of antibiotics within 6 months prior to the study
Xerostomia
Trial design
Parallel
Treatments tested in this trial
Behavioural intervention
BehavioralBehavioural intervention based on Bandura's self-efficacy theory aimed at improving oral hygiene adherence and periodontal treatment outcomes through patient motivation and reinforcement strategies.
Conventional oral hygiene instructions
BehavioralRoutine oral hygiene education and instructions provided during non-surgical periodontal therapy.
Treatment groups
Trial outcomes
Primary outcomes
TREATMENT ADHERENCE SCORE
Treatment adherence- defined on the basis of reduction in plaque score and dental visits attended
Secondary outcomes
PLAQUE INDEX
Turesky modification of Quigley-Hein Index (TQHI) Will be used to assess plaque score. Score range is 0 to 5. Lesser Score means better outcome and higher score means worst outcome
Full mouth bleeding score (FMBS)
FMBS is expressed as a percentage of bleeding sites: FMBS (%) = (Bleeding sites/Total sites)\*100 0% → No bleeding (excellent gingival health) 100% → Bleeding at all sites (severe inflammation)
PERCENTAGE RESIDUAL POCKETS
Treatment response- defined as the percentage sites with residual probing depth less than or equal to 4 mm without bleeding on probing at 6 months
Pocket Probing Depth
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: