Skip to content

Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Modified Atraumatic Restorative Technique

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03862014
Enrollment
48
Registered
2019-03-05
Start date
2019-07-01
Completion date
2022-06-01
Last updated
2024-05-17

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

Conditions

Dental Caries, Molar Incisor Hypomineralization

Keywords

molar incisor hypomineralization, silver diamine fluoride

Brief summary

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

Detailed description

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.

Interventions

DEVICESDF+KI

Molar with MIH will be treated with SDF+KI

DEVICESDF+KI+GIC(SMART)

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

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Two materials on two molars in one patient

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH2 yearsThe US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026