Resin Infiltration Treatment for MIH
Primary Purpose
Molar Incisor Hypomineralization, Enamel Hypoplasia, Enamel Caries
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Resin infiltration
Sponsored by
About this trial
This is an interventional treatment trial for Molar Incisor Hypomineralization focused on measuring molar incisor hypomineralisation, resin infiltration, discoloration, enamel, lesion
Eligibility Criteria
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.
Sites / Locations
- Gaziosmanpaşa University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Icon Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in the Mineralisation degree
MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence)
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)
Lesion size evaluated using cross polarization technique
Changes in the MIH lesions size was evaluated using cross polarization technique
Secondary Outcome Measures
Full Information
NCT ID
NCT04685889
First Posted
December 13, 2020
Last Updated
December 24, 2020
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT04685889
Brief Title
Resin Infiltration Treatment for MIH
Official Title
Clinical Evaluation of the Effect of Resin Infiltration Treatment on Hypomineralised Enamel Surfaces
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
June 23, 2018 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization, Enamel Hypoplasia, Enamel Caries, Anterior Teeth
Keywords
molar incisor hypomineralisation, resin infiltration, discoloration, enamel, lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Icon Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Resin infiltration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the Mineralisation degree
Description
MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence)
Time Frame
Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Title
Changes in the lesion colour
Description
Changes in the MIH lesions colour was evaluated using VITA EasyShade (Spectrophotometers are equipped with sensors that can measure in many wavelengths)
Time Frame
Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Title
Lesion size evaluated using cross polarization technique
Description
Changes in the MIH lesions size was evaluated using cross polarization technique
Time Frame
Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halenur Altan, assoc. prof.
Organizational Affiliation
Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rabia Erağca Yılmaz, Msc. Dt.
Organizational Affiliation
Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpaşa University
City
Tokat
ZIP/Postal Code
60100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11641576
Citation
Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.
Results Reference
background
PubMed Identifier
23351220
Citation
Jeremias F, de Souza JF, Silva CM, Cordeiro Rde C, Zuanon AC, Santos-Pinto L. Dental caries experience and Molar-Incisor Hypomineralization. Acta Odontol Scand. 2013 May-Jul;71(3-4):870-6. doi: 10.3109/00016357.2012.734412. Epub 2013 Jan 28.
Results Reference
background
PubMed Identifier
11310241
Citation
Jalevik B, Noren JG. Enamel hypomineralization of permanent first molars: a morphological study and survey of possible aetiological factors. Int J Paediatr Dent. 2000 Dec;10(4):278-89. doi: 10.1046/j.1365-263x.2000.00210.x.
Results Reference
background
PubMed Identifier
15153976
Citation
Fearne J, Anderson P, Davis GR. 3D X-ray microscopic study of the extent of variations in enamel density in first permanent molars with idiopathic enamel hypomineralisation. Br Dent J. 2004 May 22;196(10):634-8; discussion 625. doi: 10.1038/sj.bdj.4811282.
Results Reference
background
PubMed Identifier
30019508
Citation
Dantas-Neta NB, Soares Figueiredo M, Lima CCB, Bendo CB, Matos de Andrade EM, Lima MDM, Pordeus IA, Paiva SM. Factors associated with molar-incisor hypomineralisation in schoolchildren aged 8-10 years: a case-control study. Int J Paediatr Dent. 2018 Nov;28(6):570-577. doi: 10.1111/ipd.12412. Epub 2018 Jul 17.
Results Reference
background
PubMed Identifier
18637048
Citation
Cho SY, Ki Y, Chu V. Molar incisor hypomineralization in Hong Kong Chinese children. Int J Paediatr Dent. 2008 Sep;18(5):348-52. doi: 10.1111/j.1365-263X.2008.00927.x. Epub 2008 Jul 10.
Results Reference
background
PubMed Identifier
14529334
Citation
Dietrich G, Sperling S, Hetzer G. Molar incisor hypomineralisation in a group of children and adolescents living in Dresden (Germany). Eur J Paediatr Dent. 2003 Sep;4(3):133-7.
Results Reference
background
PubMed Identifier
22384801
Citation
Heitmuller D, Thiering E, Hoffmann U, Heinrich J, Manton D, Kuhnisch J, Neumann C, Bauer CP, Heinrich-Weltzien R, Hickel R; GINIplus Study Group. Is there a positive relationship between molar incisor hypomineralisations and the presence of dental caries? Int J Paediatr Dent. 2013 Mar;23(2):116-24. doi: 10.1111/j.1365-263X.2012.01233.x. Epub 2012 Mar 2.
Results Reference
background
PubMed Identifier
19016928
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.
Results Reference
background
PubMed Identifier
19253064
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.
Results Reference
background
PubMed Identifier
22629075
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.
Results Reference
background
PubMed Identifier
31808584
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.
Results Reference
background
PubMed Identifier
17426404
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. doi: 10.1159/000099323.
Results Reference
background
PubMed Identifier
16805354
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.
Results Reference
background
PubMed Identifier
17586715
Citation
Paris S, Meyer-Lueckel H, Kielbassa AM. Resin infiltration of natural caries lesions. J Dent Res. 2007 Jul;86(7):662-6. doi: 10.1177/154405910708600715.
Results Reference
background
PubMed Identifier
17138712
Citation
Zandona AF, Zero DT. Diagnostic tools for early caries detection. J Am Dent Assoc. 2006 Dec;137(12):1675-84; quiz 1730. doi: 10.14219/jada.archive.2006.0113. Erratum In: J Am Dent Assoc. 2007 Mar;138(3):298.
Results Reference
background
PubMed Identifier
15286128
Citation
Lussi A, Hibst R, Paulus R. DIAGNOdent: an optical method for caries detection. J Dent Res. 2004;83 Spec No C:C80-3. doi: 10.1177/154405910408301s16.
Results Reference
background
PubMed Identifier
10628000
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. doi: 10.1080/014051199102179.
Results Reference
background
PubMed Identifier
23810050
Citation
Knosel 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.
Results Reference
background
PubMed Identifier
18786755
Citation
Farah RA, Drummond BK, Swain MV, Williams S. Relationship between laser fluorescence and enamel hypomineralisation. J Dent. 2008 Nov;36(11):915-21. doi: 10.1016/j.jdent.2008.07.012. Epub 2008 Sep 10.
Results Reference
background
PubMed Identifier
9467310
Citation
Johnston WM, Reisbick MH. Color and translucency changes during and after curing of esthetic restorative materials. Dent Mater. 1997 Mar;13(2):89-97. doi: 10.1016/s0109-5641(97)80017-6.
Results Reference
background
PubMed Identifier
21172402
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.
Results Reference
background
PubMed Identifier
24385411
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.
Results Reference
background
PubMed Identifier
22144817
Citation
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.
Results Reference
background
PubMed Identifier
3479360
Citation
Ruyter IE, Nilner K, Moller B. Color stability of dental composite resin materials for crown and bridge veneers. Dent Mater. 1987 Oct;3(5):246-51. doi: 10.1016/S0109-5641(87)80081-7. No abstract available.
Results Reference
background
PubMed Identifier
2715476
Citation
Johnston WM, Kao EC. Assessment of appearance match by visual observation and clinical colorimetry. J Dent Res. 1989 May;68(5):819-22. doi: 10.1177/00220345890680051301.
Results Reference
background
PubMed Identifier
32368763
Citation
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.
Results Reference
background
Learn more about this trial
Resin Infiltration Treatment for MIH
We'll reach out to this number within 24 hrs