Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05764187
Other study ID # JUST20220107
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 28, 2021
Est. completion date March 2023

Study information

Verified date March 2023
Source Jordan University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (WSLs) compared to that associated with conventional metal brackets.


Description:

Objectives : The main objective of this study was to investigate the relation between ceramic brackets and the development of WSL compared to that associated with conventional metal brackets. Study design: Randomized 2-parallel arm clinical trial. Materials and methods: Quantitative light induced fluorescence (QLF) images were taken for the two randomly allocated groups (Ceramic group, n=26; Metal group, n=25) of patients at T0: before the start of treatment; T1: after 2 months and T2: at 4 months after treatment). The QLF images were analyzed; Primary outcome measures: The lesion area (Pixels) and Mean amount of fluorescence loss (∆F)% and the number of newly developed lesions. Secondary outcome: Maximum fluorescence loss (∆F-Max)% and plaque surface area (∆R 30)%. Means and standard deviations for all the measured parameters at T0, T1 and T2 were calculated. Split plot analysis of variance (SPANOVA) test was used to determine the changes within each group at the different time intervals, and between the two groups. Chi square was used to compare between the two groups regarding the number of new lesions during the treatment. P value was set at 0.05 level.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 51
Est. completion date March 2023
Est. primary completion date July 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Healthy subjects seeking orthodontic treatment with mild-to-moderate crowding (not exceeding 5 mm) - No previous orthodontic treatment - Optimum oral hygiene - Maximum of 3 restored teeth - Absence of defective enamel formation in the form of hypocalcification or hypoplasia. Exclusion Criteria: - Subjects with poor oral hygiene - Defective enamel - Patients with syndromes and Oro-facial anomalies or salivary glands diseases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Orthodontic fixed appliance therapy
Follow up of white spot lesion development using quantitative light induced fluorescence in patients bonded with ceramic brackets versus patients bonded with conventional metal brackets

Locations

Country Name City State
Jordan Postgraduate Teaching Dental Clinics/JUST Irbid

Sponsors (1)

Lead Sponsor Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (31)

Abu Alhaija ES, Al-Khateeb SN, Al-Nimri KS. Prevalence of malocclusion in 13-15 year-old North Jordanian school children. Community Dent Health. 2005 Dec;22(4):266-71. — View Citation

Al-Anezi SA, Harradine NW. Quantifying plaque during orthodontic treatment: Angle Orthod. 2012 Jul;82(4):748-53. doi: 10.2319/050111-312.1. Epub 2011 Nov 1. — View Citation

Al-Khateeb S, Forsberg CM, de Josselin de Jong E, Angmar-Mansson B. A longitudinal laser fluorescence study of white spot lesions in orthodontic patients. Am J Orthod Dentofacial Orthop. 1998 Jun;113(6):595-602. doi: 10.1016/s0889-5406(98)70218-5. — View Citation

al-Khateeb S, Oliveby A, de Josselin de Jong E, Angmar-Mansson B. Laser fluorescence quantification of remineralisation in situ of incipient enamel lesions: influence of fluoride supplements. Caries Res. 1997;31(2):132-40. doi: 10.1159/000262388. — View Citation

Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004. — View Citation

Almosa NA, Sibai BS, Rejjal OA, Alqahtani N. Enamel demineralization around metal and ceramic brackets: an in vitro study. Clin Cosmet Investig Dent. 2019 Feb 28;11:37-43. doi: 10.2147/CCIDE.S190893. eCollection 2019. — View Citation

Beberhold K, Sachse-Kulp A, Schwestka-Polly R, Hornecker E, Ziebolz D. The Orthodontic Plaque Index: an oral hygiene index for patients with multibracket appliances. Orthodontics (Chic.). 2012;13(1):94-9. — View Citation

Benson PE, Parkin N, Millett DT, Dyer FE, Vine S, Shah A. Fluorides for the prevention of white spots on teeth during fixed brace treatment. Cochrane Database Syst Rev. 2004;(3):CD003809. doi: 10.1002/14651858.CD003809.pub2. — View Citation

Birnie D. Ceramic brackets. Br J Orthod. 1990 Feb;17(1):71-4. doi: 10.1179/bjo.17.1.71. — View Citation

Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655. — View Citation

Chalmers JM. Minimal intervention dentistry: part 1. Strategies for addressing the new caries challenge in older patients. J Can Dent Assoc. 2006 Jun;72(5):427-33. — 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

Fournier A, Payant L, Bouclin R. Adherence of Streptococcus mutans to orthodontic brackets. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):414-7. doi: 10.1016/s0889-5406(98)70186-6. — View Citation

Freitas AO, Marquezan M, Nojima Mda C, Alviano DS, Maia LC. The influence of orthodontic fixed appliances on the oral microbiota: a systematic review. Dental Press J Orthod. 2014 Mar-Apr;19(2):46-55. doi: 10.1590/2176-9451.19.2.046-055.oar. — View Citation

Holmen L, Thylstrup A, Artun J. Surface changes during the arrest of active enamel carious lesions in vivo. A scanning electron microscope study. Acta Odontol Scand. 1987 Dec;45(6):383-90. doi: 10.3109/00016358709096362. — View Citation

Houston WJ. The analysis of errors in orthodontic measurements. Am J Orthod. 1983 May;83(5):382-90. doi: 10.1016/0002-9416(83)90322-6. — View Citation

Julien KC, Buschang PH, Campbell PM. Prevalence of white spot lesion formation during orthodontic treatment. Angle Orthod. 2013 Jul;83(4):641-7. doi: 10.2319/071712-584.1. Epub 2013 Jan 4. — View Citation

Lim HW, Park JH, Park HH, Lee SJ. Time series analysis of patients seeking orthodontic treatment at Seoul National University Dental Hospital over the past decade. Korean J Orthod. 2017 Sep;47(5):298-305. doi: 10.4041/kjod.2017.47.5.298. Epub 2017 Jul 27. — View Citation

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. — View Citation

Lucchese A, Gherlone E. Prevalence of white-spot lesions before and during orthodontic treatment with fixed appliances. Eur J Orthod. 2013 Oct;35(5):664-8. doi: 10.1093/ejo/cjs070. Epub 2012 Oct 8. — View Citation

O'Reilly MM, Featherstone JD. Demineralization and remineralization around orthodontic appliances: an in vivo study. Am J Orthod Dentofacial Orthop. 1987 Jul;92(1):33-40. doi: 10.1016/0889-5406(87)90293-9. — 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

Park SH, Kim K, Cho S, Chung DH, Ahn SJ. Variation in adhesion of Streptococcus mutans and Porphyromonas gingivalis in saliva-derived biofilms on raw materials of orthodontic brackets. Korean J Orthod. 2022 Jul 25;52(4):278-286. doi: 10.4041/kjod21.283. Epub 2022 Jun 9. — View Citation

Passariello C, Gigola P. Adhesion and biofilm formation by oral streptococci on different commercial brackets. Eur J Paediatr Dent. 2013 Jun;14(2):125-30. — View Citation

Raju, A.S., Hegde, N.A., Reddy, V.P., Chandrashekar, B.S., Mahendra, S. and Harishkoushik, S.R. (2013) An in vivo study on bacterial colonization with metal, ceramic and self-ligating brackets: A scanning electron microscopy study. Journal of Indian Orthodontic Society, 47, 88-96.

Rammohan SN, Juvvadi SR, Gandikota CS, Challa P, Manne R, Mathur A. Adherence of Streptococcus mutans and Candida albicans to different bracket materials. J Pharm Bioallied Sci. 2012 Aug;4(Suppl 2):S212-6. doi: 10.4103/0975-7406.100206. — View Citation

Russell JS. Aesthetic orthodontic brackets. J Orthod. 2005 Jun;32(2):146-63. doi: 10.1179/146531205225021024. — View Citation

SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available. — 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

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

van der Veen MH, de Josselin de Jong E. Application of quantitative light-induced fluorescence for assessing early caries lesions. Monogr Oral Sci. 2000;17:144-62. doi: 10.1159/000061639. — View Citation

* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Lesion area Surface area of the lesion measured in Pixels 4 months
Primary Mean fluorescence loss ?F(%) Mean lesion fluorescence loss reflecting mineral loss measured in percent 4 months
Primary Maximum fluorescence loss ?Fmax(%) Deepest point of the lesion 4 months
Primary Incidence of white spot lesions The number of newly developed white spot lesions 4 months
Secondary Plaque measurement Amount of plaque around the orthodontic fixed appliance 4 months
See also
  Status Clinical Trial Phase
Completed NCT03004196 - Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans Phase 1/Phase 2
Terminated NCT04827966 - Remineralization Agents for the Treatment of White Spot Lesions N/A
Not yet recruiting NCT03973554 - Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions Phase 2
Completed NCT05757440 - Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions N/A
Completed NCT05871619 - Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions N/A
Not yet recruiting NCT03930927 - Effect of Self Assembling Peptide on White Spot Lesion Early Phase 1
Not yet recruiting NCT03721198 - RMGI Varnish Versus APF Gel in Prevention of White Spot Lesions During Orthodontic Treatment N/A
Completed NCT03526276 - Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth N/A
Recruiting NCT03823612 - Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions Phase 4
Recruiting NCT05206539 - Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children Phase 3
Completed NCT04401280 - Bioactive Glass in the Treatment of Enamel White Spot Lesions Phase 3
Completed NCT03738839 - A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence Method N/A
Recruiting NCT04994314 - White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial Phase 3
Completed NCT04992481 - Fluoride Varnish, Ozone, Octenidin and WSLs in Orthodontic Patients N/A
Recruiting NCT03217084 - Treatment of Postorthodontic White Spot Lesions Phase 4
Recruiting NCT06402500 - Color Masking Potential of Bioactive and ICON Materials N/A