Evaluation of Behaviour Intervention on Adherence and Periodontal Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPostgraduate Institute of Dental Sciences Rohtak

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Behavioural intervention

    Behavioral

    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.

  • Conventional oral hygiene instructions

    Behavioral

    Routine oral hygiene education and instructions provided during non-surgical periodontal therapy.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

TREATMENT ADHERENCE SCORE

Treatment adherence- defined on the basis of reduction in plaque score and dental visits attended

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months
2

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)

Time frame
6 months
3

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

Time frame
6 months
4

Pocket Probing Depth

Time frame
6 months

Other outcomes

Sponsors and contacts

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