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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"

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.

研究概览

研究类型

介入性

注册 (估计的)

78

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Haryana
      • Rohtak、Haryana、印度、124001
        • Postgraduate institute of dental sciences
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
有源比较器:Control Group
Participants will receive Step 1 and 2 periodontal therapy along with routine conventional oral hygiene instructions.
Routine oral hygiene education and instructions provided during non-surgical periodontal therapy.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
TREATMENT ADHERENCE SCORE
大体时间:6 months
Treatment adherence- defined on the basis of reduction in plaque score and dental visits attended
6 months

次要结果测量

结果测量
措施说明
大体时间
PLAQUE INDEX
大体时间: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
6 months
Full mouth bleeding score (FMBS)
大体时间: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)

6 months
PERCENTAGE RESIDUAL POCKETS
大体时间: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
6 months
Pocket Probing Depth
大体时间:6 months
6 months
Clinical Attachment level
大体时间:6 months
6 months
Changes in oral hygiene related self efficacy score
大体时间: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.
6 months
Changes in brief Illness perception questionnaire score
大体时间:6 months
Score ranges 0 to 80. Higher scores generally indicate a more threatening or negative perception of illness.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • Ankit Kumar

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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