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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ankit Kumar
- Numéro de téléphone: +917027808084
- E-mail: ankit7027808084@gmail.com
Lieux d'étude
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Haryana
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Rohtak, Haryana, Inde, 124001
- Postgraduate institute of dental sciences
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Contact:
- Dr. Ritika Arora
- Numéro de téléphone: +917027818084
- E-mail: drritika44@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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TREATMENT ADHERENCE SCORE
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PLAQUE INDEX
Délai: 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)
Délai: 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
Délai: 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
Délai: 6 months
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6 months
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Clinical Attachment level
Délai: 6 months
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6 months
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Changes in oral hygiene related self efficacy score
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Ankit Kumar
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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