Behavioral Intervention Program Based on Motivational Interview

Not Applicable

Active, not recruiting

• Conditions: Periodontal Diseases; Motivational Interviewing; Periodontitis
• Interventions: Procedure: Conventional treatment group (CTG); Behavioral: Motivational Interview Group (MIG)

• Registration Number: NCT05948722
• Lead Sponsor: Universidade Federal de Santa Maria

Brief Summary

The best way for dental professionals act using dialogue methods and individual approaches in daily clinical practice to change behavioral is still inconclusive. Thus, the objective will be evaluate the effect of using motivational interviewing as part of the treatment of periodontitis in order to increase the adherence of adults to adequate oral health behavior.

Detailed Description

Patient-related approaches may show better results in treatment of periodontal diseases. The best way for the dental surgeon to act using these methods is still inconclusive. The aim of this study is to evaluate the effectiveness of using motivational interviewing as part of the treatment of periodontitis in order to increase adult adherence to adequate oral health behavior. A randomized clinical trial, with a sample size of at least 72 subjects, \>18 years of age and with at least 18 teeth, will be investigated. Individuals in the test group will receive a collaborative communicative approach, inspired by the motivational interview, while the control group will receive the information/instructions in a conventional approach. The efficacy variables for evaluating the pattern of self-control of periodontal infection will be the bleeding on probing (BoP), gingival index (GI, primary efficacy variable), the plaque index (PI) and patient-based outcomes will be assessed using quality of life questionnaires. Additionally, questionnaires will be applied to obtain sociodemographic, behavioral and self-perception of oral health data. Univariate and multivariate analyzes will be performed and conducted in the Statistical Products Service Solutions software (SPSS, version 25). Thus, it will be possible to assess whether brief oral health education interventions centered on the individual can be used by dental surgeons in order to effectively improve oral hygiene behaviors in adults, obtaining better clinical results and a better quality of life for patients.

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-17
• Primary Completion: 2024-09-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Adults, over 18-year-old;
• BoP (Bleeding on probing) in at least 30% of sites;
• Diagnosed periodontitis.

Exclusion Criteria

• Smoking;
• Diabetes;
• Pregnancy (or the planning of pregnancy);
• Immunosuppressive illness or a medication, hepatitis, HIV, a bleeding illness or a anticoagulant;
• A need for the antibiotic prophylaxis;
• Hyposalivation or use of medications that cause hyposalivation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment group (CTG)	Conventional treatment group (CTG)	Participants assigned to this arm will receive the conventional treatment
Motivational Interview Group (MIG)	Motivational Interview Group (MIG)	Participants assigned to this arm will complete three to five MI sessions

Primary Outcome Measures

Name	Time	Method
The change in Bleeding on Probing to evaluate the improvement in hygiene behavior	baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year	BoP - Dichotomic response after probing the gingival sulcus. High values mean worst condition.
The change in Gingival index to evaluate the improvement in hygiene behavior	baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year	GI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.
The change in Plaque Index to evaluate the improvement in hygiene behavior	baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year	PI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.
Patient satisfaction assessed by the change in Quality of Life questionnaire	baseline, 60 days after subgingival treatment and through study completion, an average of 1 year	Quality of life - % of patients with better scores (lowest values) of quality of life. It can vary from 0 to 56.
Patient perception assessed by the change in autoperception of oral health questionnaire	baseline, 60 days after subgingival treatment and through study completion, an average of 1 year	Autoperception of oral health - rate of patients with better condition of oral health perception. The answer options are: Great; Good; Regular; Bad; Terrible. 0-4 (lower scores mean better self-perception).

Secondary Outcome Measures

Name	Time	Method
Oral hygiene-related self-efficacy assessed by the oral hygiene-related selfefficacy (OHSE) questionnaire	60 days after subgingival treatment and six months later	Oral hygiene-related self-efficacy: % of patients with higher scores of self-efficacy. It ranges from 19 to 76, higher scores mean better self-efficacy.

Trial Locations

Locations (1)

Carlos Heitor Moreira; 🇧🇷 Santa Maria, RS, Brazil