Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
45 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-06-16
Study Completion Date
2018-11-12
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Motivational Interviewing
Oral Hygiene
Orthodontic Appliance Complication
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
Motivational interviewing
Intervention Type
BEHAVIORAL
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.
Oral Hygiene Instructions
Intervention Type
BEHAVIORAL
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.
Control group
A trained periodontist delivered only oral hygiene instructions. All the participants received a G.U.M. kit with special orthodontic hygiene tools.
Group Type
ACTIVE_COMPARATOR
Oral Hygiene Instructions
Intervention Type
BEHAVIORAL
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Motivational interview
OHI
Eligibility Criteria
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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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Laboratorios Collado
UNKNOWN
Sponsor Role
collaborator
Universidad Iberoamericana
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Henry A Adames, MsC
Role: PRINCIPAL_INVESTIGATOR
Universidad Iberoamericana
Locations
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Universidad Iberoamericana UNIBE
Santo Domingo, Nacional, Dominican Republic
Site Status
Countries
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Dominican Republic
References
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Yavan MA, Kocahan S, Ozdemir S, Sokucu O. The Effects of Using Plaque-Disclosing Tablets on the Removal of Plaque and Gingival Status of Orthodontic Patients. Turk J Orthod. 2019 Dec 1;32(4):207-214. doi: 10.5152/TurkJOrthod.2019.18084. eCollection 2019 Dec.
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Petrauskiene S, Wanczewska N, Slabsinskiene E, Zemgulyte G. Self-Reported Changes in Oral Hygiene Habits among Adolescents Receiving Orthodontic Treatment. Dent J (Basel). 2019 Oct 1;7(4):96. doi: 10.3390/dj7040096.
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Arici S, Alkan A, Arici N. Comparison of different toothbrushing protocols in poor-toothbrushing orthodontic patients. Eur J Orthod. 2007 Oct;29(5):488-92. doi: 10.1093/ejo/cjm038.
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Moshkelgosha V, Mehrvarz S, Saki M, Golkari A. Computer-Based Oral Hygiene Instruction versus Verbal Method in Fixed Orthodontic Patients. J Dent Biomater. 2017 Mar;4(1):353-360.
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BACKGROUND
Huang J, Yao Y, Jiang J, Li C. Effects of motivational methods on oral hygiene of orthodontic patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Nov;97(47):e13182. doi: 10.1097/MD.0000000000013182.
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Skidmore KJ, Brook KJ, Thomson WM, Harding WJ. Factors influencing treatment time in orthodontic patients. Am J Orthod Dentofacial Orthop. 2006 Feb;129(2):230-8. doi: 10.1016/j.ajodo.2005.10.003.
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Kay E, Locker D. A systematic review of the effectiveness of health promotion aimed at improving oral health. Community Dent Health. 1998 Sep;15(3):132-44.
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Rollnick S, Miller WR, Butler C. Motivational Interviewing in Health Care. Helping Patients Change Behavior. New York, NY, USA: Guilford Press; 2008
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BACKGROUND
Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother. 2009 Mar;37(2):129-40. doi: 10.1017/S1352465809005128.
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Gao X, Lo EC, McGrath C, Ho SM. Face-to-face individual counseling and online group motivational interviewing in improving oral health: study protocol for a randomized controlled trial. Trials. 2015 Sep 18;16:416. doi: 10.1186/s13063-015-0946-0.
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BACKGROUND
Miller WR, Rollnick S. Motivational interviewing: Helping people change. 3rd ed. New York: Guilford Press; 2013
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Miller RW, Rollnick S. Motivational Interviewing: Preparing People for Change. New York: Guilford Press; 2002.
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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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Chen SM, Creedy D, Lin HS, Wollin J. Effects of motivational interviewing intervention on self-management, psychological and glycemic outcomes in type 2 diabetes: a randomized controlled trial. Int J Nurs Stud. 2012 Jun;49(6):637-44. doi: 10.1016/j.ijnurstu.2011.11.011. Epub 2011 Dec 30.
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Koerber A, Crawford J, O'Connell K. The effects of teaching dental students brief motivational interviewing for smoking-cessation counseling: a pilot study. J Dent Educ. 2003 Apr;67(4):439-47.
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Spirito A, Sindelar-Manning H, Colby SM, Barnett NP, Lewander W, Rohsenow DJ, Monti PM. Individual and family motivational interventions for alcohol-positive adolescents treated in an emergency department: results of a randomized clinical trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):269-74. doi: 10.1001/archpediatrics.2010.296.
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Tripp SB, Perry JT, Romney S, Blood-Siegfried J. Providers as weight coaches: using practice guides and motivational interview to treat obesity in the pediatric office. J Pediatr Nurs. 2011 Oct;26(5):474-9. doi: 10.1016/j.pedn.2011.07.009.
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Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol. 2009 Sep;64(6):527-37. doi: 10.1037/a0016830.
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Tonetti MS, Eickholz P, Loos BG, Papapanou P, van der Velden U, Armitage G, Bouchard P, Deinzer R, Dietrich T, Hughes F, Kocher T, Lang NP, Lopez R, Needleman I, Newton T, Nibali L, Pretzl B, Ramseier C, Sanz-Sanchez I, Schlagenhauf U, Suvan JE. Principles in prevention of periodontal diseases: Consensus report of group 1 of the 11th European Workshop on Periodontology on effective prevention of periodontal and peri-implant diseases. J Clin Periodontol. 2015 Apr;42 Suppl 16:S5-11. doi: 10.1111/jcpe.12368.
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World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
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Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.
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RESULT
Madariaga ACP, Bucci R, Rongo R, Simeon V, D'Anto V, Valletta R. Impact of Fixed Orthodontic Appliance and Clear Aligners on the Periodontal Health: A Prospective Clinical Study. Dent J (Basel). 2020 Jan 2;8(1):4. doi: 10.3390/dj8010004.
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RESULT
Gao X, Lo EC, Kot SC, Chan KC. Motivational interviewing in improving oral health: a systematic review of randomized controlled trials. J Periodontol. 2014 Mar;85(3):426-37. doi: 10.1902/jop.2013.130205. Epub 2013 Jun 27.
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RESULT
McGrath C. Behavioral Sciences in the Promotion of Oral Health. J Dent Res. 2019 Dec;98(13):1418-1424. doi: 10.1177/0022034519873842.
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RESULT
Renz A, Ide M, Newton T, Robinson PG, Smith D. Psychological interventions to improve adherence to oral hygiene instructions in adults with periodontal diseases. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD005097. doi: 10.1002/14651858.CD005097.pub2.
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RESULT
Brand VS, Bray KK, MacNeill S, Catley D, Williams K. Impact of single-session motivational interviewing on clinical outcomes following periodontal maintenance therapy. Int J Dent Hyg. 2013 May;11(2):134-41. doi: 10.1111/idh.12012. Epub 2012 Dec 24.
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RESULT
Kay EJ, Vascott D, Hocking A, Nield H. Motivational interviewing in general dental practice: A review of the evidence. Br Dent J. 2016 Dec 16;221(12):785-791. doi: 10.1038/sj.bdj.2016.952.
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RESULT
Cascaes AM, Bielemann RM, Clark VL, Barros AJ. Effectiveness of motivational interviewing at improving oral health: a systematic review. Rev Saude Publica. 2014 Feb;48(1):142-53. doi: 10.1590/s0034-8910.2014048004616.
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RESULT
Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
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GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
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RESULT
Raju PK, Vasanti D, Kumar JR, Niranjani K, Kumar MS. Oral Hygiene Levels in Children of Tribal Population of Eastern Ghats: An Epidemiological Study. J Int Oral Health. 2015 Jul;7(7):108-10.
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RESULT
Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
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RESULT
Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S74-S84. doi: 10.1002/JPER.17-0719.
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RESULT
Discepoli N, Mirra R, Marruganti C, Beneforti C, Doldo T. Efficacy of Behaviour Change Techniques to improve oral hygiene control of individuals undergoing orthodontic therapy. A systematic review. Int J Dent Hyg. 2021 Feb;19(1):3-17. doi: 10.1111/idh.12468. Epub 2020 Oct 15.
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RESULT
Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
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RESULT
Borrelli B, Tooley EM, Scott-Sheldon LA. Motivational Interviewing for Parent-child Health Interventions: A Systematic Review and Meta-Analysis. Pediatr Dent. 2015 May-Jun;37(3):254-65.
Reference Type
RESULT
Stenman J, Wennstrom JL, Abrahamsson KH. A brief motivational interviewing as an adjunct to periodontal therapy-A potential tool to reduce relapse in oral hygiene behaviours. A three-year study. Int J Dent Hyg. 2018 May;16(2):298-304. doi: 10.1111/idh.12308. Epub 2017 Aug 24.
Reference Type
RESULT
Faustino-Silva DD, Meyer E, Hugo FN, Hilgert JB. Effectiveness of Motivational Interviewing Training for Primary Care Dentists and Dental Health Technicians: Results from a Community Clinical Trial. J Dent Educ. 2019 May;83(5):585-594. doi: 10.21815/JDE.019.063. Epub 2019 Mar 11.
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RESULT
Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck JM. The Motivational Interviewing Treatment Integrity Code (MITI 4): Rationale, Preliminary Reliability and Validity. J Subst Abuse Treat. 2016 Jun;65:36-42. doi: 10.1016/j.jsat.2016.01.001. Epub 2016 Jan 13.
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RESULT
Lundahl B, Burke BL. The effectiveness and applicability of motivational interviewing: a practice-friendly review of four meta-analyses. J Clin Psychol. 2009 Nov;65(11):1232-45. doi: 10.1002/jclp.20638.
Reference Type
RESULT
Lundahl B, Droubay BA, Burke B, Butters RP, Nelford K, Hardy C, Keovongsa K, Bowles M. Motivational interviewing adherence tools: A scoping review investigating content validity. Patient Educ Couns. 2019 Dec;102(12):2145-2155. doi: 10.1016/j.pec.2019.07.003. Epub 2019 Jul 25.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CEI2017-06
Identifier Type: -
Identifier Source: org_study_id
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