NCT03862014

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

2.9 years

First QC Date

March 1, 2019

Last Update Submit

May 15, 2024

Conditions

Dental CariesMolar Incisor Hypomineralization

Keywords

molar incisor hypomineralizationsilver diamine fluoride

Outcome Measures

Primary Outcomes (1)

  • Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH

    The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations.

    2 years

Study Arms (2)

SDF+KI

EXPERIMENTAL

SDF+KI will be applied on molars with MIH

Device: SDF+KI

SMART(SDF+KI+GIC)

ACTIVE COMPARATOR

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

Device: SDF+KI+GIC(SMART)

Interventions

SDF+KIDEVICE

Molar with MIH will be treated with SDF+KI

SDF+KI
SDF+KI+GIC(SMART)DEVICE

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

SMART(SDF+KI+GIC)

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

  • Erbas Unverdi G, Ballikaya E, Cehreli ZC. Clinical comparison of silver diamine fluoride (SDF) or silver-modified atraumatic restorative technique (SMART) on hypomineralised permanent molars with initial carious lesions: 3-year results of a prospective, randomised trial. J Dent. 2024 Aug;147:105098. doi: 10.1016/j.jdent.2024.105098. Epub 2024 May 24.

    PMID: 38797490DERIVED

  • Ballikaya E, Unverdi GE, Cehreli ZC. Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2197-2205. doi: 10.1007/s00784-021-04236-5. Epub 2021 Nov 6.

    PMID: 34743243DERIVED

MeSH Terms

Conditions

Dental CariesMolar Hypomineralization

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Zafer Cehreli

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Two materials on two molars in one patient
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 5, 2019

Study Start

July 1, 2019

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

IPD is available from the corresponding author on reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Starting 6 months after publication
Access Criteria
IPD is available from the corresponding author on reasonable request.

Locations

TU(1)