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Motivational Interview and Orthodontic Patients

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ClinicalTrials.gov Identifier: NCT04871373
Recruitment Status : Completed
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Collaborator:
Laboratorios Collado
Information provided by (Responsible Party):
Universidad Iberoamericana

Study Description
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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.


Condition or disease Intervention/treatment Phase
Motivational Interviewing Oral Hygiene Orthodontic Appliance Complication Behavioral: Motivational interviewing Behavioral: Oral Hygiene Instructions Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Two dentists were in charge of the study logistic. They 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. This system was only known by the logistics managers and the interviewer (the periodontist who provided the OHI and the MI). Thus, the participant and the evaluator (the periodontist who recorded the data) were masked.
Primary Purpose: Prevention
Official Title: The Effect of Motivational Interviewing on Oral Hygiene Behavior in Patients With Fixed Orthodontic Appliances: A Randomised Clinical Trial
Actual Study Start Date : June 16, 2017
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
A trained periodontist delivered oral hygiene instructions and motivational interviewing sessions. All the participants received a G.U.M. kit with special orthodontic hygiene tools.
 Behavioral: Motivational interviewing
A periodontist was trained and evaluated by two expert psychologists in MI, who also supervised the interviewer to ensure that the intervention was properly applied. The periodontist conducted sessions of motivational interviewing monthly to the participants of the experimental group.
Other Name: Motivational interview

Behavioral: Oral Hygiene Instructions
A periodontist delivered OHI to all the participants of both studied groups. Also, every single patient received a G.U.M. kit with special orthodontic hygiene tools.
Other Name: OHI
Active Comparator: Control group
A trained periodontist delivered only oral hygiene instructions. All the participants received a G.U.M. kit with special orthodontic hygiene tools.
 Behavioral: Oral Hygiene Instructions
A periodontist delivered OHI to all the participants of both studied groups. Also, every single patient received a G.U.M. kit with special orthodontic hygiene tools.
Other Name: OHI


Outcome Measures
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Primary Outcome Measures :
  1. Simplified Oral Hygiene Index [ Time Frame: Base line. ]
    six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.

  2. Simplified Oral Hygiene Index [ Time Frame: 3rd month ]
    six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.

  3. Simplified Oral Hygiene Index [ Time Frame: 6th month ]
    six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.


Secondary Outcome Measures :
  1. Gingival Index [ Time Frame: Base line, 3 and 6 months after the intervention. ]
    Each of the four gingival areas of the tooth is given a score from 0 to 3; this is the gingival índex for the area.

  2. Periodontal Probing Depth [ Time Frame: Base line, 3 and 6 months after the intervention. ]
    One tooth per sextant was chosen and the average was calculated.

  3. Bleeding on Probing [ Time Frame: Base line, 3 and 6 months after the intervention. ]
    Dichotomic response after probing the gingival sulcus.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871373


Locations
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Dominican Republic
Universidad Iberoamericana UNIBE
Santo Domingo, Distrito Nacional, Dominican Republic, 22333
Sponsors and Collaborators
Universidad Iberoamericana
Laboratorios Collado
Investigators
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Principal Investigator: Henry A Adames, MsC Universidad Iberoamericana
  Study Documents (Full-Text)

Documents provided by Universidad Iberoamericana:
Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2021

More Information
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Publications of Results:

Other Publications:
Rollnick S, Miller WR, Butler C. Motivational Interviewing in Health Care. Helping Patients Change Behavior. New York, NY, USA: Guilford Press; 2008
Miller WR, Rollnick S. Motivational interviewing: Helping people change. 3rd ed. New York: Guilford Press; 2013
Miller RW, Rollnick S. Motivational Interviewing: Preparing People for Change. New York: Guilford Press; 2002.
Miller WR. A small study of training in motivational interviewing: does one workshop change clinician and client behavior? Behav Cogn Psychother 2001;29:457-71.

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Responsible Party: Universidad Iberoamericana
ClinicalTrials.gov Identifier: NCT04871373    
Other Study ID Numbers: CEI2017-06
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Iberoamericana:
Motivational interviewing
Oral hygiene
Fixed orthodontic appliances
Treatment adherence