Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871373
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2021-04-23
Brief Title:
Motivational Interview and Orthodontic Patients
Sponsor:
Universidad Iberoamericana
Organization:
Universidad Iberoamericana
Study Overview
Official Title:
The Effect of Motivational Interviewing on Oral Hygiene Behavior in Patients With Fixed Orthodontic Appliances A Randomised Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A parallel-group randomized clinical trial was conducted with 45 patients of the Orthodontic Clinic of Universidad Iberoamericanas 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 V210 was used to random allocate participants into the experimental or the control group Monthly oral hygiene instructions and a GUM 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
A computer-generated list of numbers created with Statistical Package for the Social Sciences SPSS V210 was used to random allocate participants into the experimental or the control group Monthly oral hygiene instructions and a GUM 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 090 with an alpha α of 005 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 its 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 V210 with a 1125 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 GUM 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 GUM 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
Due to the matter that repeated measures ANOVA treats each measurement as a separate variable and its 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 V210 with a 1125 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 GUM 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 GUM 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None