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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

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Clinical performance of GIC and giomer restorations on primary teeth [ Time Frame: 2 years ]
    The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations.
  • Long-term success of caries sealing on primary teeth [ Time Frame: 2 years ]
    Evaluation criteria will be:
    • Spontaneous pain (absent/present);
    • Tenderness to percussion/palpation (absent/present);
    • Mobility (no mobility/ 1mm/ 2mm/ 3mm mobility)
    • Swelling (absent/present);
    • Fistula (absent/present)
    • Pus drainage (absent/present).
Change History Complete list of historical versions of study NCT03872986 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caries Sealing Using Giomer and Glass Ionomer Cement With or Without Silver Diamine Fluoride
Official Title  ICMJE Clinical Evaluation of Caries Sealing Technique on Primary Teeth Using Giomer and Glass Ionomer Cement (GIC) With or Without Silver Diamine Fluoride (SDF)
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Caries, Dental
  • Caries Class I
Intervention  ICMJE
  • Device: SDF
    Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)
  • Device: Giomer
    Beautifil II dental restorative material
  • Device: GIC
    Equia forte dental restorative material
Study Arms  ICMJE
  • Experimental: SDF+Giomer
    Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material
    Interventions:
    • Device: SDF
    • Device: Giomer
  • Experimental: Giomer only
    Beautifil II dental restorative material
    Intervention: Device: Giomer
  • Experimental: SDF+GIC
    Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte
    Interventions:
    • Device: SDF
    • Device: GIC
  • Experimental: GIC only
    Equia forte dental restorative material
    Intervention: Device: GIC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Zafer C Cehreli 00905353197969 zcehreli@gmail.com
Contact: Gizem Erbas Unverdi 00905052805736 erbasgizem@yahoo.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03872986
Other Study ID Numbers  ICMJE Caries sealing
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
Study Sponsor  ICMJE Hacettepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zafer Cehreli Hacettepe University
PRS Account Hacettepe University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP