Behavioral Intervention Program Based on Motivational Interview

Sponsor
Universidade Federal de Santa Maria (Other)
Overall Status
Recruiting
CT.gov ID
NCT05948722
Collaborator
(none)
72
1
2
16
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational Interview Group (MIG)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Behavioral Intervention Program Based on Motivational Interview to Improve Oral Hygiene in Adults - A Randomized Clinical Trial
Actual Study Start Date :
May 2, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Motivational Interview Group (MIG)

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

Behavioral: Motivational Interview Group (MIG)
Behavioral intervention program based on motivational interview beyond conventional treatment

Active Comparator: Conventional treatment group (CTG)

Participants assigned to this arm will receive the conventional treatment

Behavioral: Motivational Interview Group (MIG)
Behavioral intervention program based on motivational interview beyond conventional treatment

Outcome Measures

Primary Outcome Measures

  1. The change in Bleeding on Probing (BoP) 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

  2. The change in Plaque Index (PI) 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

  3. The change in Gingival index (GI) 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

  4. Patient satisfaction assessed by the change in Quality of Life (QoL) questionnaire [baseline, 60 days after subgingival treatment and through study completion, an average of 1 year]

    Quality of life - % of patients with better scores of QoL

  5. 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 higher scores of oral health perception (ordinal score)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Carlos Heitor Moreira Santa Maria RS Brazil 97015-900

Sponsors and Collaborators

  • Universidade Federal de Santa Maria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carlos Heitor Cunha Moreira, Principal Investigator, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier:
NCT05948722
Other Study ID Numbers:
  • 059082
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 17, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2023