Skip to main content
OpenTrials
Completed

NCT Number: NCT04127929

Investigation of Glass Carbomer Performance

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

25 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem vakif university

Istanbul, Fatih, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20-25 years of age
  • No systemic diseases
  • Presence of molar / premolar teeth with occlusal and / or interface caries
  • Lack of parafunctional habits such as clenching and grinding of teeth
  • Lack of cooperation problems
  • 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

Treatment and study plan

Restoration of cavities using glass carbomer material (GCP Dental)

Other

Detection of caries then restoration of cavities

Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)

Other

Detection of caries then restoration of cavities

Primary outcomes

  1. Evaluation of criterias

    Time frame: 1 week

    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.

Secondary outcomes

  1. Evaluation of criterias

    Time frame: 6-months

    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

Other outcomes

  1. Evaluations of criterias

    Time frame: 12-months

    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.

Sponsors and collaborators

Lead sponsor

Okan University

Other

Collaborators

  • Bezmialem Vakif University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 16, 2019
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.