NCT03872986

Brief Summary

The purpose of this study is to evaluate and compare the clinical performance of Giomer and GIC restorations with and without SDF on caries sealing of primary molar teeth

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

February 4, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

March 8, 2019

Last Update Submit

March 12, 2021

Conditions

Caries, DentalCaries Class I

Keywords

primary teethsilver diamine fluoridecaries sealing

Outcome Measures

Primary Outcomes (6)

  • The US Public Health Service criteria for secondary caries on restorations

    A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries

    2 years

  • The US Public Health Service criteria for retention of restorations

    Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration

    2 years

  • The US Public Health Service criteria for marginal discoloration on restorations

    Alpha: No visual evidence of discoloration Bravo: Slight staining which can be polished away Charlie: Discoloration has penetrated in the pulpal direction

    2 years

  • The US Public Health Service criteria for marginal adaptation on restorations

    Alpha: Restoration is fully intact. No explorer catch evident Bravo: Slight explorer catch in no more than 1/3 of margins Charlie: Explorer catch and/or penetration is evident in more than 1/3 of restoration margin

    2 years

  • The US Public Health Service criteria for surface roughness on restorations

    Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked

    2 years

  • The US Public Health Service criteria for anatomical form on restorations

    A: No loss on anatomical form of the restoration B: Change in anatomical form but dentin or cement is not expose C: Change in anatomical form that expose dentin or cement

    2 years

Study Arms (4)

SDF+Giomer

EXPERIMENTAL

Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material

Device: SDFDevice: Giomer

Giomer only

EXPERIMENTAL

Beautifil II dental restorative material

Device: Giomer

SDF+GIC

EXPERIMENTAL

Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte

Device: SDFDevice: GIC

GIC only

EXPERIMENTAL

Equia forte dental restorative material

Device: GIC

Interventions

SDFDEVICE

Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)

SDF+GICSDF+Giomer
GiomerDEVICE

Beautifil II dental restorative material

Giomer onlySDF+Giomer
GICDEVICE

Equia forte dental restorative material

GIC onlySDF+GIC

Eligibility Criteria

Age6 Years - 8 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 who have at least four first and/or second primary molars that require class I restorations
  • Teeth that have healthy lamina dura and periodontal ligament
  • Teeth that have caries lesions not extending to the pulp radiographically
  • Patients whose first molar teeth are in occlusion

You may not qualify if:

  • Patients and parents of the patients who does not accept to participate and sign the informed consent
  • Teeth which need endodontic treatment
  • Teeth that have caries more than one surface
  • Teeth that are previously restored
  • Patients who are not cooperative for the dental procedure
  • Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
  • Patients who have bruxism, skeletal or dental malocclusion
  • Teeth that have developmental defects/anomalies or discoloration
  • Patients who have allergies to resin based restorative materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Hacettepe university

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Zafer Cehreli

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zafer C Cehreli

CONTACT

00905353197969zcehreli@gmail.com

Gizem Erbas Unverdi

CONTACT

00905052805736erbasgizem@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 13, 2019

Study Start

February 4, 2021

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

TU(2)