Evaluation of Behaviour Intervention on Adherence and Periodontal Outcomes

"Evaluation of an Individual-centric Self-efficacy Based Behavioural Intervention on Adherence and Clinical Outcomes of Periodontal Therapy-A Randomised Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis With Low Oral Hygiene-related Self-efficacy
• Intervention / Treatment: Behavioral: Behavioural intervention; Behavioral: Conventional oral hygiene instructions

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ankit Kumar; Phone Number: +917027808084; Email: ankit7027808084@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Postgraduate institute of dental sciences
      • Contact: Dr. Ritika Arora; Phone Number: +917027818084; Email: drritika44@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Inclusion criteria at the patient level, age ≥ 18 years
2. According to the 2017 EFP/AAP classification, patients with periodontitis stage I-III, with low self-efficacy will be included
3. 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

  1. According to American Society of Anesthesiologists Physical Status classification P3 and P4 will be excluded.
  2. Use of antibiotics within 6 months prior to the study
  3. Xerostomia
  4. Physical inability to perform oral hygiene procedures
  5. Use of drugs influencing gingival hyperplasia or bleeding.
  6. Presence of an acute condition requiring emergency dental treatment
  7. Any periodontal treatment in the past 1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; 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; 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.
Active Comparator: Control Group; Participants will receive Step 1 and 2 periodontal therapy along with routine conventional oral hygiene instructions.	Behavioral: Conventional oral hygiene instructions; Routine oral hygiene education and instructions provided during non-surgical periodontal therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TREATMENT ADHERENCE SCORE	Treatment adherence- defined on the basis of reduction in plaque score and dental visits attended	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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)	6 months
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	6 months
Pocket Probing Depth		6 months
Clinical Attachment level		6 months
Changes in oral hygiene related self efficacy score	Score ranges from 19 to 76.lesser score means low self efficacy and higher score means high self efficacy related to oral hygiene.	6 months
Changes in brief Illness perception questionnaire score	Score ranges 0 to 80. Higher scores generally indicate a more threatening or negative perception of illness.	6 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Ankit Kumar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No