Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-06-01

Brief Summary

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The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride+Potassium Iodide (SDF+KI) and Silver-Modified Atraumatic Restorative Technique (SMART/SDF+KI+GIC) on molars with MIH

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Detailed Description

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SDF+KI and SMART (SDF+KI+GIC) were placed on two permanent molar teeth with MIH, in a split mouth design. 48 patients were included in the study. The teeth were randomized into two groups according to the dental restorative material.

Group 1: SDF+KI (Riva Star), Group 2: SDF+KI (Riva Star) +GIC (Equia Forte). The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) was used for clinical evaluation of atraumatic resin restorations. The restorations were evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos were taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.

Fisher's Exact test, Kaplan-Meier Survival Curves, Log-rank test, Mann Whitney U test, and Friedman test was performed for the statistical analysis.

Conditions

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Dental Caries Molar Incisor Hypomineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Two materials on two molars in one patient

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SDF+KI

SDF+KI will be applied on molars with MIH

Group Type EXPERIMENTAL

SDF+KI

Intervention Type DEVICE

Molar with MIH will be treated with SDF+KI

SMART(SDF+KI+GIC)

SDF+KI+GIC will be applied on molars with MIH

Group Type ACTIVE_COMPARATOR

SDF+KI+GIC(SMART)

Intervention Type DEVICE

Molar with MIH will be treated with SDF+KI+GIC(SMART)

Interventions

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SDF+KI

Molar with MIH will be treated with SDF+KI

Intervention Type DEVICE

SDF+KI+GIC(SMART)

Molar with MIH will be treated with SDF+KI+GIC(SMART)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients and parents of the patients who accept to participate and sign the informed consent
* Patients whose molar teeth are diagnosed as molar incisor hypomineralization by EAPD
* Teeth that are fully erupted
* Patients who have at least two permanent first molars that need fissure sealant
* Teeth that have white-yellow-brown discoloration that indicate high-caries risk

Exclusion Criteria

* Teeth that are previously restored or have caries
* Patients who have orthodontic treatment
* Patients who are not cooperative for the dental procedure
* Teeth that have dental fluorosis or enamel malformation according to the specific syndromes

Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes