Evaluation of Behaviour Intervention on Adherence and Periodontal Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Behavioural intervention, Conventional oral hygiene instructions.
- Who it may be relevant to
- Registry conditions: Periodontitis With Low Oral Hygiene-related Self-efficacy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
"Evaluation of an Individual-centric Self-efficacy Based Behavioural Intervention on Adherence and Clinical Outcomes of Periodontal Therapy-A Randomised Controlled Trial"
Overview
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.
Interventions
- Behavioral Behavioural intervention
Behavioural intervention based on Bandura's self-efficacy theory aimed at improving oral hygiene adherence and periodontal treatment outcomes through patient motivation and reinforcement strategies. - Behavioral Conventional oral hygiene instructions
Routine oral hygiene education and instructions provided during non-surgical periodontal therapy.
Primary outcome measures
- TREATMENT ADHERENCE SCORE [Time frame: 6 months]
Secondary outcome measures (7)
- PLAQUE INDEX [Time frame: 6 months]
- Full mouth bleeding score (FMBS) [Time frame: 6 months]
- PERCENTAGE RESIDUAL POCKETS [Time frame: 6 months]
- Pocket Probing Depth [Time frame: 6 months]
- Clinical Attachment level [Time frame: 6 months]
- Changes in oral hygiene related self efficacy score [Time frame: 6 months]
- Changes in brief Illness perception questionnaire score [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Physical inability to perform oral hygiene procedures
- Use of drugs influencing gingival hyperplasia or bleeding.
- Presence of an acute condition requiring emergency dental treatment
- Any periodontal treatment in the past 1 year
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
India · 1 center
- Postgraduate institute of dental sciences — Rohtak
Identifiers
NCT: NCT07614737 · Ankit Kumar