Resin Infiltration Treatment for MIH

Molar Incisor Hypomineralization Clinical Trial

Official title:

Clinical Evaluation of the Effect of Resin Infiltration Treatment on Hypomineralised Enamel Surfaces

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685889
• Other study ID #: 2018/35
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: December 2020
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months.

Description:

A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was applied to teeth with MIH, while the healthy teeth received no treatment (control).

Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Group II (Control Group): No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization technique, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 20, 2019
• Est. primary completion date: June 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

Inclusion Criteria:

• Molar incisor hypomineralisation on the labial surface of permanent central teeth Least one of the labial surface of the permanent anterior teeth were affected by MIH.

Exclusion Criteria:

• Dental caries and filling on anterior teeth.

• Dental anomaly on anterior teeth.

• Undergoing orthodontic treatment.

• Periodontal diseases.

• Cognitive and behavioural problems.

Related Conditions & MeSH terms

• Anterior Teeth
• Dental Enamel Hypoplasia
• Enamel Caries
• Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Procedure:
• Resin infiltration
A sufficient amount of HCl was applied to the lesion using the icon etch syringe included in the set and was allowed to sit for 2 minutes. After washing with water for 30 seconds, the tooth was dried using an air spray. Once the enamel surface appeared chalky, Icon® dry application was initiated. Ethanol was applied to the lesion using the Icon® dry syringe included in the set, and after 30 seconds it was dried using an air spray. Sufficient amount of resin infiltrant was applied to the lesion using the Icon® infiltrant syringe. The resin infiltrant was applied to the lesion surface by massaging with the tip of the syringe in circular movements for 3 minutes such that it penetrates the surface thoroughly. The resin infiltrant was polymerized for 40 seconds with a light device.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (27)

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Khanna R, Chandra A, Singh RK. Quantitative evaluation of masking effect of resin infiltration on developmental defects of enamel. Quintessence Int. 2020;51(6):448-455. doi: 10.3290/j.qi.a44493. — View Citation

Knösel M, Eckstein A, Helms HJ. Durability of esthetic improvement following Icon resin infiltration of multibracket-induced white spot lesions compared with no therapy over 6 months: a single-center, split-mouth, randomized clinical trial. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):86-96. doi: 10.1016/j.ajodo.2013.02.029. — View Citation

Kuscu OO, Caglar E, Aslan S, Durmusoglu E, Karademir A, Sandalli N. The prevalence of molar incisor hypomineralization (MIH) in a group of children in a highly polluted urban region and a windfarm-green energy island. Int J Paediatr Dent. 2009 May;19(3):176-85. doi: 10.1111/j.1365-263X.2008.00945.x. Epub 2008 Nov 11. — View Citation

Lussi A, Hibst R, Paulus R. DIAGNOdent: an optical method for caries detection. J Dent Res. 2004;83 Spec No C:C80-3. Review. — View Citation

Martos J, Gewehr A, Paim E. Aesthetic approach for anterior teeth with enamel hypoplasia. Contemp Clin Dent. 2012 Apr;3(Suppl 1):S82-5. doi: 10.4103/0976-237X.95112. — View Citation

Meyer-Lueckel H, Paris S, Kielbassa AM. Surface layer erosion of natural caries lesions with phosphoric and hydrochloric acid gels in preparation for resin infiltration. Caries Res. 2007;41(3):223-30. — View Citation

Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23. — View Citation

Paris S, Meyer-Lueckel H, Kielbassa AM. Resin infiltration of natural caries lesions. J Dent Res. 2007 Jul;86(7):662-6. — View Citation

Robertson AJ, Toumba KJ. Cross-polarized photography in the study of enamel defects in dental paediatrics. J Audiov Media Med. 1999 Jun;22(2):63-70. — View Citation

Rocha Gomes Torres C, Borges AB, Torres LM, Gomes IS, de Oliveira RS. Effect of caries infiltration technique and fluoride therapy on the colour masking of white spot lesions. J Dent. 2011 Mar;39(3):202-7. doi: 10.1016/j.jdent.2010.12.004. Epub 2010 Dec 21. — View Citation

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Shivanna V, Shivakumar B. Novel treatment of white spot lesions: A report of two cases. J Conserv Dent. 2011 Oct;14(4):423-6. doi: 10.4103/0972-0707.87217. — View Citation

Soviero V, Haubek D, Trindade C, Da Matta T, Poulsen S. Prevalence and distribution of demarcated opacities and their sequelae in permanent 1st molars and incisors in 7 to 13-year-old Brazilian children. Acta Odontol Scand. 2009;67(3):170-5. doi: 10.1080/00016350902758607. — View Citation

Weerheijm KL, Jälevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. — View Citation

William V, Messer LB, Burrow MF. Molar incisor hypomineralization: review and recommendations for clinical management. Pediatr Dent. 2006 May-Jun;28(3):224-32. Review. — View Citation

Yetkiner E, Wegehaupt F, Wiegand A, Attin R, Attin T. Colour improvement and stability of white spot lesions following infiltration, micro-abrasion, or fluoride treatments in vitro. Eur J Orthod. 2014 Oct;36(5):595-602. doi: 10.1093/ejo/cjt095. Epub 2014 Jan 2. — View Citation

Zandoná AF, Zero DT. Diagnostic tools for early caries detection. J Am Dent Assoc. 2006 Dec;137(12):1675-84; quiz 1730. Review. Erratum in: J Am Dent Assoc. 2007 Mar;138(3):298. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Mineralisation degree	MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence)	Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Primary	Changes in the lesion colour	Changes in the MIH lesions colour was evaluated using VITA EasyShade (Spectrophotometers are equipped with sensors that can measure in many wavelengths)	Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Primary	Lesion size evaluated using cross polarization technique	Changes in the MIH lesions size was evaluated using cross polarization technique	Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later