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Набор скоро начнётся NCT07614737

Evaluation of Behaviour Intervention on Adherence and Periodontal Outcomes

Без фазы С лечением Periodontitis With Low Oral Hygiene-related Self-efficacy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Behavioural intervention, Conventional oral hygiene instructions.
Кому может быть актуально
Состояния в реестре: Periodontitis With Low Oral Hygiene-related Self-efficacy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

  • TREATMENT ADHERENCE SCORE [Срок оценки: 6 months]
Вторичные конечные точки (7)
  • PLAQUE INDEX [Срок оценки: 6 months]
  • Full mouth bleeding score (FMBS) [Срок оценки: 6 months]
  • PERCENTAGE RESIDUAL POCKETS [Срок оценки: 6 months]
  • Pocket Probing Depth [Срок оценки: 6 months]
  • Clinical Attachment level [Срок оценки: 6 months]
  • Changes in oral hygiene related self efficacy score [Срок оценки: 6 months]
  • Changes in brief Illness perception questionnaire score [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Индия · 1 центр
  • Postgraduate institute of dental sciences — Rohtak

Идентификаторы

NCT: NCT07614737 · Ankit Kumar

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗