Investigation of Glass Carbomer Performance

Dental Caries Clinical Trial

Official title:

12-Month Clinical Performance Evaluation of a Current Glass Carbomer Restorative System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04127929
• Other study ID #: 280486
• Status: Completed
• Phase: N/A
• Start date: September 9, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: October 2019
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 10, 2018
• Est. primary completion date: September 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Restoration of cavities using glass carbomer material (GCP Dental)
Detection of caries then restoration of cavities
• Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)
Detection of caries then restoration of cavities

Locations

Country	Name	City	State
Turkey	Bezmialem vakif university	Istanbul	Fatih

Sponsors (2)

Lead Sponsor	Collaborator
Okan University	Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluations of criterias	In this clinical study, the restorations were evaluated.Restorations were scored using the terms Alpha, Bravo and Charlie.Alpha was used for restorations that were considered clinically successful; Bravo was used for the restorations with several deficiencies but requiring no replacement; and Charlie was used for the clinically unacceptable restorations where the restoration had to be replaced.2. When the restorations made using glass carbomer filling materials were evaluated in terms of anatomic form, retention, and marginal adaptation, restorations with Charlie score in the 12-months.	12-months
Primary	Evaluation of criterias	In this clinical study, the restorations were evaluated.Restorations were scored. using the terms Alpha, Bravo and Charlie.Alpha was used for restorations that were considered clinically successful; Bravo was used for the restorations with several deficiencies but requiring no replacement; and Charlie was used for the clinically unacceptable restorations where the restoration had to be replaced.End of the one-week there was no significant differences between restorative materials for all evaluation criterias, were mentioned in summary.	1 week
Secondary	Evaluation of criterias	In this clinical study, the restorations were evaluated.Restorations were scored using the terms Alpha, Bravo and Charlie.Alpha was used for restorations that were considered clinically successful; Bravo was used for the restorations with several deficiencies but requiring no replacement; and Charlie was used for the clinically unacceptable restorations where the restoration had to be replaced.2. When the restorations made using glass carbomer filling materials were evaluated in terms of anatomic form, retention, and marginal adaptation, restorations with Charlie score in the 6-months	6-months