Evaluation of Behaviour Intervention on Adherence and Periodontal Outcomes

NCT07614737 | Not Yet Recruiting

• 1 other identifier: Ankit Kumar
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis With Low Oral Hygiene-related Self-efficacy

Outcome Measures

Primary Outcomes (1)

• TREATMENT ADHERENCE SCORE

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

  6 months

Secondary Outcomes (7)

• PLAQUE INDEX

  6 months

• Full mouth bleeding score (FMBS)

  6 months

• PERCENTAGE RESIDUAL POCKETS

  6 months

• Pocket Probing Depth

  6 months

• Clinical Attachment level

  6 months

Study Arms (2)

Test Group

EXPERIMENTAL

Participants will receive Step 1 and 2 periodontal therapy along with an individual-centric self-efficacy-based behavioural intervention including verbal persuasion, mastery experience, vicarious experience, and emotional reinforcement in addition to conventional oral hygiene instructions.

Behavioral: Behavioural intervention

Control Group

ACTIVE COMPARATOR

Participants will receive Step 1 and 2 periodontal therapy along with routine conventional oral hygiene instructions.

Behavioral: Conventional oral hygiene instructions

Interventions

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.

Test Group

Conventional oral hygiene instructions BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Postgraduate institute of dental sciences

Rohtak, Haryana, 124001, India

Location

Central Study Contacts

Ankit Kumar

CONTACT

+917027808084; ankit7027808084@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)