Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
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ClinicalTrials.gov Identifier: NCT02717286 |
Recruitment Status :
Completed
First Posted : March 23, 2016
Last Update Posted : March 30, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Molar Incisor Hypomineralization | Procedure: restorative | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2015 |
Arm | Intervention/treatment |
---|---|
Sham Comparator: Control
20 first permanent molars from children aged between 6 to 12 years old presenting MIH will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the European Academy of Pediatric Dentistry (EADP) criteria. Intervention of Control: The restorative treatment using a total-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing. |
Procedure: restorative
It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive) |
Experimental: Test
20 first permanent molars from children aged between 6 to 12 years old presenting Molar Incisor Hypomineralization will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the EAPD criteria. Intervention of test: the restorative treatment using a self-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), air jet (5 s), adhesive application (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing. |
Procedure: restorative
It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive) |
- Survival rates of the direct restorative treatment [ Time Frame: 6 months ]

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Ages Eligible for Study: | 6 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- children and/or parents who agree in participate of the study
- children were born and living in Araraquara, SP, Brazil
- presence of the first permanent molars totally erupted with defects classified as enamel post eruptive breakdown (PEB) or unsatisfactory atypical restoration (UATR), with or without carious lesions.
Exclusion Criteria:
- children and/or parents who do not agree in participate of the study
- first permanent molars with enamel malformation associated with syndromes,
- dental fluorosis,
- first permanent molars with destroyed crowns,
- imperfect amelogenesis
- fixed orthodontic appliances.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717286
Brazil | |
UNESP - Univ. Estadual Paulista | |
Araraquara, SP, Brazil, 14801-903 |
Study Chair: | Rita de Cássia Loiola Cordeiro, PhD | UNESP- Univ Estadual Paulista |
Responsible Party: | Juliana Feltrin de Souza Caparroz, Juliana Feltrin de Souza, Universidade Federal do Paraná |
ClinicalTrials.gov Identifier: | NCT02717286 |
Other Study ID Numbers: |
UFParana |
First Posted: | March 23, 2016 Key Record Dates |
Last Update Posted: | March 30, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Dental Enamel Hypoplasia Tooth Abnormalities Stomatognathic System Abnormalities |
Stomatognathic Diseases Tooth Diseases Congenital Abnormalities |