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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ankit Kumar
- 전화번호: +917027808084
- 이메일: ankit7027808084@gmail.com
연구 장소
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Haryana
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Rohtak, Haryana, 인도, 124001
- Postgraduate institute of dental sciences
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연락하다:
- Dr. Ritika Arora
- 전화번호: +917027818084
- 이메일: drritika44@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: Control Group
Participants will receive Step 1 and 2 periodontal therapy along with routine conventional oral hygiene instructions.
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Routine oral hygiene education and instructions provided during non-surgical periodontal therapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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TREATMENT ADHERENCE SCORE
기간: 6 months
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Treatment adherence- defined on the basis of reduction in plaque score and dental visits attended
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PLAQUE INDEX
기간: 6 months
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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
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6 months
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Full mouth bleeding score (FMBS)
기간: 6 months
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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
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PERCENTAGE RESIDUAL POCKETS
기간: 6 months
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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
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6 months
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Pocket Probing Depth
기간: 6 months
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6 months
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Clinical Attachment level
기간: 6 months
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6 months
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Changes in oral hygiene related self efficacy score
기간: 6 months
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Score ranges from 19 to 76.lesser score means low self efficacy and higher score means high self efficacy related to oral hygiene.
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6 months
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Changes in brief Illness perception questionnaire score
기간: 6 months
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Score ranges 0 to 80. Higher scores generally indicate a more threatening or negative perception of illness.
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6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Ankit Kumar
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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