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

Caries, Dental Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03872986
• Other study ID #: Caries sealing
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2021
• Source: Hacettepe University
• Contact: Zafer C Cehreli
• Phone: 00905353197969
• Email: zcehreli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries Class I
• Caries, Dental
• Dental Caries

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara
Turkey	Hacettepe university	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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