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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"

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07614737
Enrollment
78
Registered
2026-05-29
Start date
2026-06-01
Completion date
2027-09-30
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis With Low Oral Hygiene-related Self-efficacy

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.

Interventions

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.

BEHAVIORALConventional oral hygiene instructions

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

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
TREATMENT ADHERENCE SCORE6 monthsTreatment adherence- defined on the basis of reduction in plaque score and dental visits attended

Secondary

MeasureTime frameDescription
PLAQUE INDEX6 monthsTuresky 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
Full mouth bleeding score (FMBS)6 monthsFMBS 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)
PERCENTAGE RESIDUAL POCKETS6 monthsTreatment response- defined as the percentage sites with residual probing depth less than or equal to 4 mm without bleeding on probing at 6 months
Pocket Probing Depth6 months
Clinical Attachment level6 months
Changes in oral hygiene related self efficacy score6 monthsScore ranges from 19 to 76.lesser score means low self efficacy and higher score means high self efficacy related to oral hygiene.
Changes in brief Illness perception questionnaire score6 monthsScore ranges 0 to 80. Higher scores generally indicate a more threatening or negative perception of illness.

Countries

India

Contacts

CONTACTAnkit Kumar
ankit7027808084@gmail.com+917027808084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026