Clinical trial NCT04871373: Motivational Interview and Orthodontic Patients
Official title: The Effect of Motivational Interviewing on Oral Hygiene Behavior in Patients With Fixed Orthodontic Appliances: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivational Interviewing
Oral Hygiene
Orthodontic Appliance Complication
Keywords: Motivational interviewing
Oral hygiene
Fixed orthodontic appliances
Treatment adherence
Lead sponsor: Universidad Iberoamericana
Sponsor class: OTHER
Collaborators: name: Laboratorios Collado
First posted: 2021-05-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Orthodontic patients were recruited to be divided into a control group (that received oral hygiene instructions) and an experimental group (that received oral hygiene instructions and motivational interviewing sessions).
Primary purpose: PREVENTION

Brief summary: A parallel-group randomized clinical trial was conducted with 45 patients of the Orthodontic Clinic of Universidad Iberoamericana's (UNIBE) Postgraduate Unit. The study hypothesis was that motivational interview plus oral hygiene instructions would be more effective in maintaining long-term oral hygiene in comparison with conventional oral hygiene instructions alone.

A computer-generated list of numbers created with Statistical Package for the Social Sciences (SPSS) V21.0 was used to random allocate participants into the experimental or the control group. Monthly oral hygiene instructions and a G.U.M. kit were given to the sample. Additionally, the experimental group received motivational interviewing sessions by a trained periodontist. Simplified Oral Hygiene Index, Gingival Index, Periodontal Probing Depth and Bleeding on Probing were recorded at baseline, three and six months after the beginning of the study. Repeated-measures analysis of variance and chi-squared test were conducted.

Detailed description: Sample calculation A power analysis was carried out to determine the number of subjects needed to achieve a Simplified Oral Hygiene Index (SOHI) significant interaction with the study groups when applying repeated measures ANOVA. The total number of completed subjects needed to achieve power of 0.90 with an alpha (α) of 0.05, an effect size (f) of at least .25 was determined to be 36; taking into consideration a possible 10% attrition rate, 45 subjects were recruited, consented and randomized to either the experimental or control group.

Due to the matter that repeated measures ANOVA treats each measurement as a separate variable, and it's preferable to use listwise deletion, if one measurement is missing, the whole case gets dropped. For this reason and therefore the incontrovertible fact that the trial suffers attrition, the sample for the three measurements was reduced to 32 subjects.

Randomization A simple randomization procedure was executed by the principal investigator to allocate the participants into one of the study groups. A computer-generated list of numbers was created using the software SPSS V21.0, with a 1:1.25 allocation ratio.

Two dentists enrolled and allocated the participants according to the order of arrival and following the list of random numbers. A coding system was used as a concealment mechanism, which consisted of colored labels attached to the participants' file. Thus, the participant and the evaluator (the periodontist who recorded the data) were masked.

Study intervention An interviewer was in charge of providing oral hygiene instructions for both groups. All the participants received a G.U.M. kit with special orthodontic hygiene tools. Then, the patients of the experimental group received a motivational interviewing session.

Afterward, the clinical parameters were measured by another periodontist. Monthly follow-up appointments were scheduled for the orthodontic check-ups to deliver a new G.U.M. kit, to reinforce the OHI and MI, and to register the periodontal parameters. The important data for this research was the one recorded at baseline, three and six months after the intervention.

Statistical analysis Mean Simplify oral hygiene index (SOHI), gingival index (GI), periodontal probing depth (PPD), and bleeding on probing (BoP) scores were compared between groups across three-time points using repeated-measures mixed-model analysis of variance. Tests for equality of variances and sphericity to check for homoscedasticity were performed due to the problem of sample attrition. Nevertheless, it was not found any violation to these assumptions in any of the variables included in the analysis. SPSS software was used for all calculations (IBM SPSS 25th version). Due to the nominal level of measurement of the variable BoP, it was performed a chi-squared test for each three time points to check if there were any differences between the two experimental conditions.

Eligibility criteria: Inclusion Criteria:

* Patients with 18-40 years old, systemically healthy, without active dental caries lesions or periodontal diseases, who were candidates for fixed orthodontic appliances.

Exclusion Criteria:

* Smokers and pregnant patients.
* Participants were discarded if they decided voluntarily to abandon the study of the orthodontic treatment or if they didn't attend to the periodical check-ups.

Primary outcomes:
measure: Simplified Oral Hygiene Index
timeFrame: Base line.
measure: Simplified Oral Hygiene Index
timeFrame: 3rd month
measure: Simplified Oral Hygiene Index
timeFrame: 6th month
Secondary outcomes:
measure: Gingival Index
timeFrame: Base line, 3 and 6 months after the intervention.
measure: Periodontal Probing Depth
timeFrame: Base line, 3 and 6 months after the intervention.
measure: Bleeding on Probing
timeFrame: Base line, 3 and 6 months after the intervention.
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Universidad Iberoamericana UNIBE
state: Distrito Nacional
Study officials:
affiliation: Universidad Iberoamericana
name: Henry A Adames, MsC
role: PRINCIPAL_INVESTIGATOR
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