Behavioral Intervention Program Based on Motivational Interview

NCT ID: NCT05948722

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2025-12-01

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.

Conditions

Periodontitis; Periodontal Diseases; Motivational Interviewing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Motivational Interview Group (MIG)

Participants assigned to this arm will complete three to five MI sessions

Group Type: EXPERIMENTAL

Motivational Interview Group (MIG)

Intervention Type: BEHAVIORAL

Brief MI intervention with the conventional treatment

Conventional treatment group (CTG)

Participants assigned to this arm will receive the conventional treatment

Group Type: ACTIVE_COMPARATOR

Conventional treatment group (CTG)

Intervention Type: PROCEDURE

Conventional treatment

Interventions

Motivational Interview Group (MIG)

Brief MI intervention with the conventional treatment

Intervention Type: BEHAVIORAL

Conventional treatment group (CTG)

Conventional treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Carlos Heitor Cunha Moreira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Carlos Heitor Moreira

Santa Maria, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

059082

Identifier Type: -

Identifier Source: org_study_id