Effectiveness of Educational Interventions in the Prevention of Caries in Patients With Orthodontics

Dental Caries Clinical Trial

Official title:

Effectiveness of Motivational Interviewing and Conventional Interventions in the Prevention of Vestibular Caries in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05979805
• Other study ID #: ECA 103-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: April 20, 2025

Study information

• Verified date: August 2023
• Source: Universidad Nacional de Colombia
• Contact: Adriana Forero Niño, DDs
• Phone: (571) 3102416420
• Email: apforeron[@]unal.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dental caries is classified by the World Health Organization (WHO) as an important public health problem due to its high prevalence and incidence worldwide despite the development of public policies to combat it. It is a chronic disease that has a severe impact in terms of pain and suffering, impairment of function and effect on quality of life. During orthodontic treatments, the most common adverse event is the appearance of dental caries lesions due to increased retention, change of dental biofilm composition or difficulty of removal with conventional oral hygiene techniques. Efforts to implement various conventional preventive interventions of self-care and education have not decreased its incidence, so it is necessary to implement motivational interventions to help adolescents and young adults to make positive changes in their oral health habits, which are constant and lasting and prevent and control caries.

Description:

Dental caries is a multifactorial disease but the only necessary factor, although insufficient for its development, is bacterial biofilm; brackets significantly increase its retention and limit self- cleaning mechanisms, representing a challenge in clinical practice. Motivational interventions in oral health could be an alternative to generate behavioral changes in oral health and daily self-care routines that are more sustainable over time compared to conventional education models in patients with fixed orthodontic appliances.

A controlled, randomized, parallel and pragmatic clinical study is proposed for the evaluation of the effect of conventional educational intervention and motivational interviewing in comparison with conventional educational interventions in the prevention of dental caries lesions. A sample size of 94 patients in total is proposed, distributed 47 in each arm of the study, with a follow-up of the cohort for six months. The baseline risk will be established before the placement of fixed appliances (T0), and a follow-up will be carried out during six months, with assessments in one (T1), three(T2) and six months (T3) after cementation, where the presence of caries and changes in risk variables, adverse events and adherence to conventional and motivational interventions, will be measured.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: April 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 28 Years

Eligibility

Inclusion Criteria:

• Patients enrolled in the different orthodontic postgraduate clinics of the National University of Colombia who requires treatment with fixed orthodontic appliances

• 13 years old up to 44 years of age.

Exclusion Criteria:

• Patients with untreated caries lesions

• Patients with periodontal diseases

• Previous orthodontics treatments

• Severe fluorosis or enamel abnormalities.

• Medical compromise

• Medical treatments generating hyposalivation or gingival enlargement,

• Craniomaxillary anomalies

• Cognitive or motor disability

• Pregnancy.

Related Conditions & MeSH terms

• Dental Caries
• Tooth Demineralization

Intervention

Other:
• Conventional Educational interventions
Conventional educational methods can be verbal, written or visual and can be combined for greater understanding and effectiveness in oral health and dietary routines. The education are imparted in the first appointment of the appliances cementation by a video and oral health instruction booklet and each patient receive an oral hygiene kit. This education is repeated in month 1 and 3 after appliances cementation.

Behavioral:
• Motivational intervention
In addition to the conventional educational method, a motivational interviewing (MI) by Miller and Rollnick of 30 minutes will be used, with an initial script according to the stage of change in each patient in T0. The reinforcements of motivational interviewing are in month one and three after the installation of the braces, they will have the same methodology but will be focused on the aspects that in the previous session or in the clinical assessment were detected as the most important deficiencies or risk factors for the patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Colombia

References & Publications (19)

Acharya S, Goyal A, Utreja AK, Mohanty U. Effect of three different motivational techniques on oral hygiene and gingival health of patients undergoing multibracketed orthodontics. Angle Orthod. 2011 Sep;81(5):884-8. doi: 10.2319/112210-680.1. Epub 2011 May 25. — View Citation

Aljabaa A, McDonald F, Newton JT. A systematic review of randomized controlled trials of interventions to improve adherence among orthodontic patients aged 12 to 18. Angle Orthod. 2015 Mar;85(2):305-13. doi: 10.2319/031214-184.1. Epub 2014 Jul 21. — View Citation

Chapman JA, Roberts WE, Eckert GJ, Kula KS, Gonzalez-Cabezas C. Risk factors for incidence and severity of white spot lesions during treatment with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):188-94. doi: 10.1016/j.ajodo.2008.10.019. — View Citation

Ekstrand KR, Gimenez T, Ferreira FR, Mendes FM, Braga MM. The International Caries Detection and Assessment System - ICDAS: A Systematic Review. Caries Res. 2018;52(5):406-419. doi: 10.1159/000486429. Epub 2018 Mar 8. — View Citation

Enaia M, Bock N, Ruf S. White-spot lesions during multibracket appliance treatment: A challenge for clinical excellence. Am J Orthod Dentofacial Orthop. 2011 Jul;140(1):e17-24. doi: 10.1016/j.ajodo.2010.12.016. — View Citation

Fejerskov O. Concepts of dental caries and their consequences for understanding the disease. Community Dent Oral Epidemiol. 1997 Feb;25(1):5-12. doi: 10.1111/j.1600-0528.1997.tb00894.x. — View Citation

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. — View Citation

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. — View Citation

Guarnizo-Herreno CC, Watt RG, Garzon-Orjuela N, Suarez-Zuniga E, Tsakos G. Health insurance and education: major contributors to oral health inequalities in Colombia. J Epidemiol Community Health. 2019 Aug;73(8):737-744. doi: 10.1136/jech-2018-212049. Epub 2019 May 16. — View Citation

Marinho VC, Higgins JP, Sheiham A, Logan S. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2003;2003(1):CD002278. doi: 10.1002/14651858.CD002278. — View Citation

Martignon S, Ekstrand KR, Lemos MI, Lozano MP, Higuera C. Plaque, caries level and oral hygiene habits in young patients receiving orthodontic treatment. Community Dent Health. 2010 Sep;27(3):133-8. — View Citation

Ogaard B, Rolla G, Arends J. Orthodontic appliances and enamel demineralization. Part 1. Lesion development. Am J Orthod Dentofacial Orthop. 1988 Jul;94(1):68-73. doi: 10.1016/0889-5406(88)90453-2. — View Citation

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. — View Citation

Scheerman JFM, van Empelen P, van Loveren C, Pakpour AH, van Meijel B, Gholami M, Mierzaie Z, van den Braak MCT, Verrips GHW. An application of the Health Action Process Approach model to oral hygiene behaviour and dental plaque in adolescents with fixed orthodontic appliances. Int J Paediatr Dent. 2017 Nov;27(6):486-495. doi: 10.1111/ipd.12287. Epub 2017 Feb 7. — View Citation

Scheerman JFM, van Meijel B, van Empelen P, Kramer GJC, Verrips GHW, Pakpour AH, Van den Braak MCT, van Loveren C. Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances. BMC Oral Health. 2018 Feb 7;18(1):19. doi: 10.1186/s12903-018-0475-9. — View Citation

Shimpo Y, Nomura Y, Sekiya T, Arai C, Okada A, Sogabe K, Hanada N, Tomonari H. Effects of the Dental Caries Preventive Procedure on the White Spot Lesions during Orthodontic Treatment-An Open Label Randomized Controlled Trial. J Clin Med. 2022 Feb 6;11(3):854. doi: 10.3390/jcm11030854. — View Citation

Sundararaj D, Venkatachalapathy S, Tandon A, Pereira A. Critical evaluation of incidence and prevalence of white spot lesions during fixed orthodontic appliance treatment: A meta-analysis. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):433-9. doi: 10.4103/2231-0762.167719. — View Citation

Talic NF. Adverse effects of orthodontic treatment: A clinical perspective. Saudi Dent J. 2011 Apr;23(2):55-9. doi: 10.1016/j.sdentj.2011.01.003. Epub 2011 Jan 28. — View Citation

Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Measurement of possible adverse events during educational interventional at T0 (baseline), T1 (one month), T2 (three months) and T3 (six months) after the start of orthodontic treatment with fixed appliances.	6 months
Primary	Changes in ICDAS score of the caries	Change in incidence of caries on the vestibular surface by ICDAS in T0 (baseline),T1 (1 month),T2 (3 months) and T3 (6 months) will be censured when the patient presents the outcome, the study period ends (six months) or when the follow-up period finishes for a reason other than the event of interest being studied.	6 months
Secondary	Change of Plaque index	Changes in modification of the Silness and Löe index described by Williams at T0 (baseline), T1 (one month), T2 (three months) and T3 (six months) after the start of orthodontic treatment with fixed appliances.	6 months