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Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

U

Universidade Federal do Paraná

Status

Completed

Conditions

Molar Incisor Hypomineralization

Treatments

Procedure: restorative

Study type

Interventional

Funder types

Other

Identifiers

NCT02717286
UFParana

Details and patient eligibility

About

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.

Full 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%).

Enrollment

26 patients

Sex

All

Ages

6 to 8 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

26 participants in 2 patient groups

Control
Sham Comparator group
Description:
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.
Treatment:
Procedure: restorative
Test
Experimental group
Description:
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.
Treatment:
Procedure: restorative

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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