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Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717286
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Juliana Feltrin de Souza Caparroz, Universidade Federal do Paraná

Brief Summary:
The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH, comparing two adhesive systems.

Condition or disease Intervention/treatment Phase
Molar Incisor Hypomineralization Procedure: restorative Not Applicable

Detailed Description:
For the research, it was selected first permanent molars (FPMs) with MIH from children aged 6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was performed during 18 months according to the USPHS-Modified by a blinded examiner. The actuarial method was used to evaluate survival of the restorations and Fisher's exact test was used to compare differences between the groups (α=5%).

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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)




Primary Outcome Measures :
  1. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Brazil
UNESP - Univ. Estadual Paulista
Araraquara, SP, Brazil, 14801-903
Sponsors and Collaborators
Universidade Federal do Paraná
Investigators
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Study Chair: Rita de Cássia Loiola Cordeiro, PhD UNESP- Univ Estadual Paulista
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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
Additional relevant MeSH terms:
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Dental Enamel Hypoplasia
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities