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NCT Number: NCT07614737

Evaluation of Behaviour Intervention on Adherence and Periodontal Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. TREATMENT ADHERENCE SCORE

    Time frame: 6 months

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

Secondary outcomes

  1. PLAQUE INDEX

    Time frame: 6 months

    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

  2. Full mouth bleeding score (FMBS)

    Time frame: 6 months

    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)

  3. PERCENTAGE RESIDUAL POCKETS

    Time frame: 6 months

    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

  4. Pocket Probing Depth

    Time frame: 6 months

  5. Clinical Attachment level

    Time frame: 6 months

  6. Changes in oral hygiene related self efficacy score

    Time frame: 6 months

    Score ranges from 19 to 76.lesser score means low self efficacy and higher score means high self efficacy related to oral hygiene.

  7. Changes in brief Illness perception questionnaire score

    Time frame: 6 months

    Score ranges 0 to 80. Higher scores generally indicate a more threatening or negative perception of illness.

Study contacts

Contact information is provided by the study sponsor or research team.

Ankit Kumar

CONTACT

[email protected]

+917027808084

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.