Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02717286

Enrollment

Registered

2016-03-23

Start date

2013-01-31

Completion date

2015-10-31

Last updated

2016-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Incisor Hypomineralization

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.

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%).

Interventions

PROCEDURErestorative

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 8 Years

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.

Design outcomes

Primary

Measure	Time frame
Survival rates of the direct restorative treatment	6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026