Molar Incisor Hypomineralization Clinical Trial
Official title:
Clinical Evaluation of Giomer and Resin-based Fissure Sealants Performed in Permanent Molar Teeth Affected by Molar-Incisor Hypomineralization
Verified date | June 2021 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this research was to evaluate the clinical success of giomer and resin-based sealants applied in the first permanent molars (FPMs) affected by MIH.
Status | Completed |
Enrollment | 57 |
Est. completion date | January 20, 2020 |
Est. primary completion date | December 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - Healthy children, aged 6-12 years, who attended the pediatric dentistry clinic regular dental examination - Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria - Presenting at least two FPMs that were fully erupted and indicated for non-invasive fissure sealant. - The FPMs with white, yellow or brown lesions, indicating mechanical and chemical alteration of the enamel and increased caries risk Exclusion Criteria: - Children having hypomineralized FPMs with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances - Enamel defect due to a condition other than MIH |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara | Altindag |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Fragelli CMB, Souza JF, Bussaneli DG, Jeremias F, Santos-Pinto LD, Cordeiro RCL. Survival of sealants in molars affected by molar-incisor hypomineralization: 18-month follow-up. Braz Oral Res. 2017 Apr 27;31:e30. doi: 10.1590/1807-3107BOR-2017.vol31.0030. — View Citation
Lygidakis NA, Dimou G, Stamataki E. Retention of fissure sealants using two different methods of application in teeth with hypomineralised molars (MIH): a 4 year clinical study. Eur Arch Paediatr Dent. 2009 Dec;10(4):223-6. — View Citation
Weerheijm KL, Jälevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical performance evaluation using USPHS Criteria | Clinical evaluation was performed by two blinded examiners in accordance with the modified-USPHS criteria, to assess anatomic form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months | 12 months |
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