Clinical trial NCT05948722: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontitis
Periodontal Diseases
Motivational Interviewing
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in Bleeding on Probing to evaluate the improvement in hygiene behavior
timeFrame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
measure: The change in Plaque Index to evaluate the improvement in hygiene behavior
timeFrame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
measure: The change in Gingival index to evaluate the improvement in hygiene behavior
timeFrame: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
measure: Patient satisfaction assessed by the change in Quality of Life questionnaire
timeFrame: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
measure: Patient perception assessed by the change in autoperception of oral health questionnaire
timeFrame: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
Secondary outcomes:
measure: Oral hygiene-related self-efficacy assessed by the oral hygiene-related selfefficacy (OHSE) questionnaire
timeFrame: 60 days after subgingival treatment and six months later
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Carlos Heitor Moreira
state: RS
Study officials:
References: