Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

• ClinicalTrials.gov Identifier: NCT02717286
• Recruitment Status: Completed
• First Posted: March 23, 2016
• Last Update Posted: March 30, 2016
• Sponsor: Universidade Federal do Paraná
• Information provided by (Responsible Party): Juliana Feltrin de Souza Caparroz, Universidade Federal do Paraná

Study Description

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%).

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Survival rates of the direct restorative treatment [ Time Frame: 6 months ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Brazil

UNESP - Univ. Estadual Paulista

Araraquara, SP, Brazil, 14801-903

Sponsors and Collaborators

Universidade Federal do Paraná

Investigators

• Study Chair: Rita de Cássia Loiola Cordeiro, PhD; UNESP- Univ Estadual Paulista

More Information

• 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
• 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:

Dental Enamel Hypoplasia; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities