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Caries Sealing Using Giomer and Glass Ionomer Cement With or Without Silver Diamine Fluoride

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ClinicalTrials.gov Identifier: NCT03872986
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

Study Description
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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

Condition or disease Intervention/treatment Phase
Caries, Dental Caries Class I Device: SDF Device: Giomer Device: GIC Not Applicable

Detailed Description:

Restorations will be placed on four primary molar teeth with occlusal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.

Group 1: SDF (Riva Star) + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 2: Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 3: SDF (Riva Star) + GIC (Equia Forte, GC, Japan) Group 4: GIC (Equia Forte, GC, Japan)

The restorations will be evaluated clinically at baseline and 6., 12., 18., 24. months and radiologically at 6., 12. and 24. months. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. Intra-oral photos will be taken directly after treatment and at control appointments.

The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Caries Sealing Technique on Primary Teeth Using Giomer and Glass Ionomer Cement (GIC) With or Without Silver Diamine Fluoride (SDF)
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SDF+Giomer
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material
 Device: SDF
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)

Device: Giomer
Beautifil II dental restorative material
Experimental: Giomer only
Beautifil II dental restorative material
 Device: Giomer
Beautifil II dental restorative material
Experimental: SDF+GIC
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte
 Device: SDF
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)

Device: GIC
Equia forte dental restorative material
Experimental: GIC only
Equia forte dental restorative material
 Device: GIC
Equia forte dental restorative material


Outcome Measures
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Primary Outcome Measures :
  1. The US Public Health Service criteria for secondary caries on restorations [ Time Frame: 2 years ]
    A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries

  2. The US Public Health Service criteria for retention of restorations [ Time Frame: 2 years ]
    Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration

  3. The US Public Health Service criteria for marginal discoloration on restorations [ Time Frame: 2 years ]
    Alpha: No visual evidence of discoloration Bravo: Slight staining which can be polished away Charlie: Discoloration has penetrated in the pulpal direction

  4. The US Public Health Service criteria for marginal adaptation on restorations [ Time Frame: 2 years ]
    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

  5. The US Public Health Service criteria for surface roughness on restorations [ Time Frame: 2 years ]
    Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked

  6. The US Public Health Service criteria for anatomical form on restorations [ Time Frame: 2 years ]
    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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872986


Contacts
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Contact: Zafer C Cehreli 00905353197969 zcehreli@gmail.com
Contact: Gizem Erbas Unverdi 00905052805736 erbasgizem@yahoo.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey, 06100
Contact: Zafer C Cehreli, DDS, PhD    +903123052289    zcehreli@gmail.com   
Contact: Gizem Erbas Unverdi, DDS, PhD    +903123052280    erbasgizem@yahoo.com   
Principal Investigator: Zafer C Cehreli, Prof         
Sub-Investigator: Gizem Erbas Unverdi, Research as.         
Sub-Investigator: Elif Ballikaya, Research as.         
Hacettepe university Recruiting
Ankara, Turkey, 06100
Contact: Gizem E Unverdi       erbasgizem@yahoo.com   
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Zafer Cehreli Hacettepe University
More Information
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Responsible Party: Zafer Cavit Cehreli, DDS, PhD, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03872986     History of Changes
Other Study ID Numbers: Caries sealing
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zafer Cavit Cehreli, DDS, PhD, Hacettepe University:
primary teeth
silver diamine fluoride
caries sealing
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
 Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs