Trials Sponsors Conditions Drugs Pricing

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

Survival rates of the direct restorative treatment
6 months

Study Arms (2)

Control

SHAM COMPARATOR

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

Test

EXPERIMENTAL

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.

Interventions

restorativeProcedure

It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)

ControlTest

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Years - 8 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

children and/or parents who agree in participate of the study
children were born and living in Araraquara, SP, Brazil

Sponsors & Collaborators

Universidade Federal do Paraná
Otherlead

Study Sites (1)

UNESP - Univ. Estadual Paulista

Araraquara, São Paulo, 14801-903, Brazil

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Rita de Cássia Loiola Cordeiro, PhD
UNESP- Univ Estadual Paulista
STUDY CHAIR

Enrollment

26 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Juliana Feltrin de Souza

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 23, 2016

Study Start

January 2013

Date type not reported

This date has not been verified as actual or estimated.

Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Control

Test

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Control

Test

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations