Investigation of Glass Carbomer Performance

NCT ID: NCT04127929

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-09
• Study Completion Date: 2018-09-10

Brief Summary

The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material.

Detailed Description

The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material.

In this study, total of 100 (46 class I, 54 class II) restorations were performed in 36 patients. All cavities were prepared conventionally. Half of the restorations were restored with nano composite resin (Tokuyama Estelite, Tokuyama Dental, Japan) and the other half were restored with glass carbomer material (GCP Dental, The Netherlands). Rubber-dam was used for isolation. Before the replacement of composite restorations, enamel edges were etched according to selective etching method. Then universal adhesive system was applied. Composite resin was applied to the cavity in 2 mm layers by incramental technique. Glass carbomer was placed with bulk technique by applying finger pressure with surface covering. Composite restorations were polymerized with LED light curing unit. Glass carbomer restorations were cured its own special curing unit. Restorations were evaluated with modified USPHS criteria at the end of the first week, 6 months and 12 months. Data were analyzed using Fisher's Exact Chi-Square test, Fisher Freeman Halton Test and Continuity (Yates) Correction. Wilcoxon sign test was used for intra-group comparisons of the parameters. Statistically significance was evaluated at p <0.05.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Glass carbomer

Group Type: ACTIVE_COMPARATOR

Restoration of cavities using glass carbomer material (GCP Dental)

Intervention Type: OTHER

Detection of caries then restoration of cavities

Tokuyama Estelite Posterior

Group Type: ACTIVE_COMPARATOR

Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)

Intervention Type: OTHER

Detection of caries then restoration of cavities

Interventions

Restoration of cavities using glass carbomer material (GCP Dental)

Detection of caries then restoration of cavities

Intervention Type: OTHER

Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)

Detection of caries then restoration of cavities

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 20-25 years of age

2. No systemic diseases

3. Presence of molar / premolar teeth with occlusal and / or interface caries

4. Lack of parafunctional habits such as clenching and grinding of teeth

5. Lack of cooperation problems

6. Accepted regular visits -

Exclusion Criteria

• 1-Any endodontic treatment or withdrawal indications (abscess, swelling and fistula complaints, palpation and percussion pain, spontaneous or night pain) 2- Teeth with congenital developmental defect 3- Teeth with pathological mobility 4- Teeth which do not have normal occlusion due to skeletal or pathological reasons 5- Lack of contact or opposite teeth

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: collaborator

Okan University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Buket Kaynar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Buket Kaynar, Dr

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem vakif university

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

280486

Identifier Type: -

Identifier Source: org_study_id