Behavioral Intervention Program Based on Motivational Interview

Study Overview
=================
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.

Official Title
-----------------
Behavioral Intervention Program Based on Motivational Interview to Improve Oral Hygiene in Adults - A Randomized Clinical Trial

Conditions
-----------------
Periodontitis, Periodontal Diseases, Motivational Interviewing

Intervention / Treatment
-----------------
* Behavioral: Motivational Interview Group (MIG)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interview Group (MIG)<br>Participants assigned to this arm will complete three to five MI sessions | Behavioral: Motivational Interview Group (MIG)<br>* Behavioral intervention program based on motivational interview beyond conventional treatment<br>|
| Active Comparator: Conventional treatment group (CTG)<br>Participants assigned to this arm will receive the conventional treatment | Behavioral: Motivational Interview Group (MIG)<br>* Behavioral intervention program based on motivational interview beyond conventional treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Bleeding on Probing (BoP) to evaluate the improvement in hygiene behavior | BoP - Dichotomic response after probing the gingival sulcus | 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 (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 | 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 (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 | 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 (QoL) questionnaire | Quality of life - % of patients with better scores of QoL | 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 higher scores of oral health perception (ordinal score) | baseline, 60 days after subgingival treatment and through study completion, an average of 1 year |