Behavioral Intervention Program Based on Motivational Interview

NCT05948722 | Active Not Recruiting

• 1 other identifier: 059082
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Periodontal Diseases; Motivational Interviewing

Outcome Measures

Primary Outcomes (5)

• The change in Bleeding on Probing to evaluate the improvement in hygiene behavior

  BoP - Dichotomic response after probing the gingival sulcus. High values mean worst condition.

  baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year

• The change in Plaque Index to evaluate the improvement in hygiene behavior

  PI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.

  baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year

• The change in Gingival index to evaluate the improvement in hygiene behavior

  GI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.

  baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year

• Patient satisfaction assessed by the change in Quality of Life questionnaire

  Quality of life - % of patients with better scores (lowest values) of quality of life. It can vary from 0 to 56.

  baseline, 60 days after subgingival treatment and through study completion, an average of 1 year

• Patient perception assessed by the change in autoperception of oral health questionnaire

  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).

  baseline, 60 days after subgingival treatment and through study completion, an average of 1 year

Secondary Outcomes (1)

• Oral hygiene-related self-efficacy assessed by the oral hygiene-related selfefficacy (OHSE) questionnaire

  60 days after subgingival treatment and six months later

Study Arms (2)

Motivational Interview Group (MIG)

EXPERIMENTAL

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

Behavioral: Motivational Interview Group (MIG)

Conventional treatment group (CTG)

ACTIVE COMPARATOR

Participants assigned to this arm will receive the conventional treatment

Procedure: Conventional treatment group (CTG)

Interventions

Motivational Interview Group (MIG) BEHAVIORAL

Brief MI intervention with the conventional treatment

Motivational Interview Group (MIG)

Conventional treatment group (CTG) PROCEDURE

Conventional treatment

Conventional treatment group (CTG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Carlos Heitor Moreira

Santa Maria, Rio Grande do Sul, 97015-900, Brazil

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: July 17, 2023
• Study Start: May 2, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)