Behavioral Intervention Program Based on Motivational Interview

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948722
• Other study ID #: 059082
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Universidade Federal de Santa Maria
• Contact: Carlos Heitor Cunha Moreira, phd
• Phone: 55+ (55) 3220-8000
• Email: carlos.moreira[@]ufsm.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Motivational Interviewing
• Periodontal Diseases
• Periodontitis

Intervention

Behavioral:
• Motivational Interview Group (MIG)
Brief MI intervention with the conventional treatment

Procedure:
• Conventional treatment group (CTG)
Conventional treatment

Locations

Country	Name	City	State
Brazil	Carlos Heitor Moreira	Santa Maria	RS

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Oral hygiene-related self-efficacy assessed by the oral hygiene-related selfefficacy (OHSE) questionnaire	Oral hygiene-related self-efficacy: % of patients with higher scores of self-efficacy. It ranges from 19 to 76, higher scores mean better self-efficacy.	60 days after subgingival treatment and six months later