Clinical Performance of Restorative Materials in Primary Teeth

Dental Caries Clinical Trial

Official title:

Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03037814
• Other study ID #: HUDHF-3-primary teeth
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: March 25, 2027

Study information

• Verified date: March 2021
• Source: Hacettepe University
• Contact: Zafer C Cehreli, DDS, PhD
• 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 dental restorative materials in Class II cavities of primary molar teeth

Description:

Restorations will be placed on four primary molar teeth with proximal 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: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2: Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12. months for the first year, and at every 6 months for 5 years. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. 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: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 25, 2027
• Est. primary completion date: July 25, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• Patients and parent of the patients who accept to participate and sign the informed consent
• Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
• Teeth that have healthy lamina dura and periodontal ligament
• Teeth that have caries lesions extending no more than the outher half of dentin radiographically

Exclusion Criteria:

• Patients and parent of the patients who don't accept to participate and sign the informed consent
• Teeth that are previously restored
• Patients who are uncooperative
• 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 or anomalies

Related Conditions & MeSH terms

• Caries; Dentin
• Dental Caries

Intervention

Device:
• Compomer
Aesthetic resin dental materials that are used to replace structure loss, commonly for dental caries of primary tooth. Compomers designed to combine the aesthetics of traditional composite resins with the fluoride release and adhesion of glass-ionomer cements.
• RMGIC
Dental restorative materials that are a combination of the desirable properties of glass-ionomer (fluoride release and chemical adhesion) with high strength and low solubility of resins.
• Giomer
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
• Amalgam
Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.

Locations

Country	Name	City	State
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	Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria	Long-term clinical success of different restorative materials in class II cavities on primary molar teeth	5 years