Behavioral Intervention Program Based on Motivational Interview
Primary Purpose
Periodontitis, Periodontal Diseases, Motivational Interviewing
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Motivational Interview Group (MIG)
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
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
Sites / Locations
- Carlos Heitor MoreiraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational Interview Group (MIG)
Conventional treatment group (CTG)
Arm Description
Participants assigned to this arm will complete three to five MI sessions
Participants assigned to this arm will receive the conventional treatment
Outcomes
Primary Outcome Measures
The change in Bleeding on Probing (BoP) to evaluate the improvement in hygiene behavior
BoP - Dichotomic response after probing the gingival sulcus
The change in Plaque Index (PI) to evaluate the improvement in hygiene behavior
PI - Each of the 6 sites of the tooth is given a score from 0 to 3
The change in Gingival index (GI) to evaluate the improvement in hygiene behavior
GI - Each of the 6 sites of the tooth is given a score from 0 to 3
Patient satisfaction assessed by the change in Quality of Life (QoL) questionnaire
Quality of life - % of patients with better scores of QoL
Patient perception assessed by the change in autoperception of oral health questionnaire
Autoperception of oral health - rate of patients with higher scores of oral health perception (ordinal score)
Secondary Outcome Measures
Full Information
NCT ID
NCT05948722
First Posted
May 2, 2023
Last Updated
July 12, 2023
Sponsor
Universidade Federal de Santa Maria
1. Study Identification
Unique Protocol Identification Number
NCT05948722
Brief Title
Behavioral Intervention Program Based on Motivational Interview
Official Title
Behavioral Intervention Program Based on Motivational Interview to Improve Oral Hygiene in Adults - A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Diseases, Motivational Interviewing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interview Group (MIG)
Arm Type
Experimental
Arm Description
Participants assigned to this arm will complete three to five MI sessions
Arm Title
Conventional treatment group (CTG)
Arm Type
Active Comparator
Arm Description
Participants assigned to this arm will receive the conventional treatment
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview Group (MIG)
Intervention Description
Behavioral intervention program based on motivational interview beyond conventional treatment
Primary Outcome Measure Information:
Title
The change in Bleeding on Probing (BoP) to evaluate the improvement in hygiene behavior
Description
BoP - Dichotomic response after probing the gingival sulcus
Time Frame
baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
Title
The change in Plaque Index (PI) to evaluate the improvement in hygiene behavior
Description
PI - Each of the 6 sites of the tooth is given a score from 0 to 3
Time Frame
baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
Title
The change in Gingival index (GI) to evaluate the improvement in hygiene behavior
Description
GI - Each of the 6 sites of the tooth is given a score from 0 to 3
Time Frame
baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
Title
Patient satisfaction assessed by the change in Quality of Life (QoL) questionnaire
Description
Quality of life - % of patients with better scores of QoL
Time Frame
baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
Title
Patient perception assessed by the change in autoperception of oral health questionnaire
Description
Autoperception of oral health - rate of patients with higher scores of oral health perception (ordinal score)
Time Frame
baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Heitor Cunha Moreira, phd
Phone
55+ (55) 3220-8000
Email
carlos.moreira@ufsm.br
Facility Information:
Facility Name
Carlos Heitor Moreira
City
Santa Maria
State/Province
RS
ZIP/Postal Code
97015-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Moreira, phd
Phone
55+5532208000
Email
carlosheitormoreira@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Behavioral Intervention Program Based on Motivational Interview
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