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

Arm | Intervention/treatment |
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Experimental: SDF+Giomer
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material
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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
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Device: Giomer
Beautifil II dental restorative material |
Experimental: SDF+GIC
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte
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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
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Device: GIC
Equia forte dental restorative material |
- 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

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

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
Contact: Zafer C Cehreli | 00905353197969 | zcehreli@gmail.com | |
Contact: Gizem Erbas Unverdi | 00905052805736 | erbasgizem@yahoo.com |
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 |
Principal Investigator: | Zafer Cehreli | Hacettepe University |
Responsible Party: | Zafer Cavit Cehreli, DDS, PhD, Principal Investigator, Hacettepe University |
ClinicalTrials.gov Identifier: | NCT03872986 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
primary teeth silver diamine fluoride caries sealing |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |