Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

White Spot Lesion Clinical Trial

Official title:

Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05738356
• Other study ID #: JUST20220118
• Status: Completed
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2024
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (WSLs) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system. All participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group. WSLs will be monitored during the orthodontic treatment

Description:

Objectives: The objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system. Materials and Methods: Seventy five patients were randomly allocated into 3 groups (Group 1, conventional bonding system, n=25; Group 2, self-etch primer n=25; Group 3, primer mixed with the adhesive composite n=25). Quantitative light-induced fluorescence (QLF) was used to quantify WSL parameters. Images were captured and then analyzed before treatment; 2 months and 4 months after bond-up. Lesion area (Pixels), mean fluorescence loss (∆F) and the number of newly developed WSLs were compared within and between the 3 groups. The significance level was set at P ≤ 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 1, 2023
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

Inclusion Criteria:

• Healthy patients from both sexes aged 17 - 25 years
• Mild-to-moderate crowding (=5 mm)
• Optimum oral hygiene
• Maximum of 3 restored teeth
• Absence of defective enamel formation in the form of hypocalcification or hypoplasia
• No salivary gland diseases.

Exclusion Criteria:

• Patients with poor oral hygiene
• Heavily restored teeth
• Sever crowding
• Presence of systemic disease that may affect salivary glands or the ability to brush their teeth properly.

Related Conditions & MeSH terms

• White Spot Lesion

Intervention

Combination Product:
• Adhesive bonding systems
Three different adhesive bonding systems were used; one system per group

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (30)

Al-Khateeb SN, Tarazi SJ, Al Maaitah EF, Al-Batayneh OB, Abu Alhaija ES. Does acid etching enhance remineralisation of arrested white spot lesions? Eur Arch Paediatr Dent. 2014 Dec;15(6):413-9. doi: 10.1007/s40368-014-0131-2. Epub 2014 Jun 21. — 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

Artun J, Brobakken BO. Prevalence of carious white spots after orthodontic treatment with multibonded appliances. Eur J Orthod. 1986 Nov;8(4):229-34. doi: 10.1093/ejo/8.4.229. No abstract available. — View Citation

Bishara SE, Ajlouni R, Laffoon JF, Warren JJ. Comparison of shear bond strength of two self-etch primer/adhesive systems. Angle Orthod. 2006 Jan;76(1):123-6. doi: 10.1043/0003-3219(2006)076[0123:COSBSO]2.0.CO;2. — View Citation

Bishara SE, Gordan VV, VonWald L, Olson ME. Effect of an acidic primer on shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop. 1998 Sep;114(3):243-7. doi: 10.1016/s0889-5406(98)70205-7. — View Citation

Bishara SE, VonWald L, Laffoon JF, Warren JJ. Effect of a self-etch primer/adhesive on the shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop. 2001 Jun;119(6):621-4. doi: 10.1067/mod.2001.113269. — 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

Brown MD, Campbell PM, Schneiderman ED, Buschang PH. A practice-based evaluation of the prevalence and predisposing etiology of white spot lesions. Angle Orthod. 2016 Mar;86(2):181-6. doi: 10.2319/041515-249.1. Epub 2015 Aug 4. — View Citation

BUONOCORE MG. A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces. J Dent Res. 1955 Dec;34(6):849-53. doi: 10.1177/00220345550340060801. No abstract available. — View Citation

Cal-Neto JP, Miguel JA. Scanning electron microscopy evaluation of the bonding mechanism of a self-etching primer on enamel. Angle Orthod. 2006 Jan;76(1):132-6. doi: 10.1043/0003-3219(2006)076[0132:SEMEOT]2.0.CO;2. — View Citation

Choi A, Yoo KH, Yoon SY, Park BS, Kim IR, Kim YI. Anti-Microbial and Remineralizing Properties of Self-Adhesive Orthodontic Resin Containing Mesoporous Bioactive Glass. Materials (Basel). 2021 Jun 25;14(13):3550. doi: 10.3390/ma14133550. — View Citation

Donly KJ, Ruiz M. In vitro demineralization inhibition of enamel caries utilizing an unfilled resin. Clin Prev Dent. 1992 Nov-Dec;14(6):22-4. — View Citation

Elkalza, A., Mostafa, D. (2018). 'Laboratory evaluation of shear bond strength of three different bonding systems for orthodontic brackets', Egyptian Orthodontic Journal, 53(June 2018), pp. 55-60. doi: 10.21608/eos.2018.77121

Frazier MC, Southard TE, Doster PM. Prevention of enamel demineralization during orthodontic treatment: an in vitro study using pit and fissure sealants. Am J Orthod Dentofacial Orthop. 1996 Nov;110(5):459-65. doi: 10.1016/s0889-5406(96)70050-1. — View Citation

Ghiz MA, Ngan P, Kao E, Martin C, Gunel E. Effects of sealant and self-etching primer on enamel decalcification. Part II: an in-vivo study. Am J Orthod Dentofacial Orthop. 2009 Feb;135(2):206-13. doi: 10.1016/j.ajodo.2007.02.060. — View Citation

Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x. — 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

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

Miller CC, Burnside G, Higham SM, Flannigan NL. Quantitative Light-induced Fluorescence-Digital as an oral hygiene evaluation tool to assess plaque accumulation and enamel demineralization in orthodontics. Angle Orthod. 2016 Nov;86(6):991-997. doi: 10.2319/092415-648.1. Epub 2016 Mar 23. — View Citation

Mohammed RE, Abass S, Abubakr NH, Mohammed ZM. Comparing orthodontic bond failures of light-cured composite resin with chemical-cured composite resin: A 12-month clinical trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):290-4. doi: 10.1016/j.ajodo.2016.02.013. — View Citation

Montasser MA, El-Wassefy NA, Taha M. In vitro study of the potential protection of sound enamel against demineralization. Prog Orthod. 2015;16:12. doi: 10.1186/s40510-015-0080-2. Epub 2015 May 22. — 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

Ogaard B. Prevalence of white spot lesions in 19-year-olds: a study on untreated and orthodontically treated persons 5 years after treatment. Am J Orthod Dentofacial Orthop. 1989 Nov;96(5):423-7. doi: 10.1016/0889-5406(89)90327-2. — View Citation

Paschos E, Kleinschrodt T, Clementino-Luedemann T, Huth KC, Hickel R, Kunzelmann KH, Rudzki-Janson I. Effect of different bonding agents on prevention of enamel demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2009 May;135(5):603-12. doi: 10.1016/j.ajodo.2007.11.028. — View Citation

Paschos E, Rosenbeck KA, Huth KC, Rudzki I, Wichelhaus A, Kunzelmann KH. Evaluation of the effect of bracket-periphery treatment on prevention of enamel demineralization by consecutive muCT scans. Clin Oral Investig. 2015 Jul;19(6):1519-26. doi: 10.1007/s00784-014-1351-x. Epub 2014 Nov 14. — View Citation

Rasmussen MJ, Togrye C, Trojan TM, Tantbirojn D, Versluis A. Post-gel shrinkage, elastic modulus, and stress generated by orthodontic adhesives. Angle Orthod. 2020 Mar;90(2):278-284. doi: 10.2319/032719-233.1. Epub 2019 Sep 23. — 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

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

Visel D, Jacker T, Jost-Brinkmann PG, Prager TM. Demineralization adjacent to orthodontic brackets after application of conventional and self-etching primer systems. J Orofac Orthop. 2014 Sep;75(5):358-73. doi: 10.1007/s00056-014-0233-9. Epub 2014 Aug 28. Erratum In: J Orofac Orthop. 2015 Jan;76(1):99. Jacker, T [corrected to Jacker, Theresa]. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average lesion fluorescence loss (?F%)	It reflects mineral loss from tooth surface (in percent)	4 months
Primary	surface area of WSL	Area of mineral loss measured in pixels	4 months
Primary	Incidence of WSL	Number of newly developed WSLs	4 months
Secondary	Maximum lesion fluorescence loss (?FMAX%)	It reflects the deepest area of the WSL (in percent)	4 months

External Links

•   Randomization App