Investigation of Glass Carbomer Performance

Sponsor
Okan University (Other)
Overall Status
Completed
CT.gov ID
NCT04127929
Collaborator
Bezmialem Vakif University (Other)
36
1
2
12
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Restoration of cavities using glass carbomer material (GCP Dental)
  • Other: Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
12-Month Clinical Performance Evaluation of a Current Glass Carbomer Restorative System
Actual Study Start Date :
Sep 9, 2017
Actual Primary Completion Date :
Sep 16, 2017
Actual Study Completion Date :
Sep 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Glass carbomer

Other: Restoration of cavities using glass carbomer material (GCP Dental)
Detection of caries then restoration of cavities

Active Comparator: Tokuyama Estelite Posterior

Other: Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)
Detection of caries then restoration of cavities

Outcome Measures

Primary Outcome Measures

  1. Evaluation of criterias [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 Outcome Measures

  1. Evaluation of criterias [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 Outcome Measures

  1. Evaluations of criterias [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem vakif university Istanbul Fatih Turkey

Sponsors and Collaborators

  • Okan University
  • Bezmialem Vakif University

Investigators

  • Principal Investigator: Zeynep Buket Kaynar, Dr, Bezmialem Vakif University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeynep Buket Kaynar, Principal Investigator, Okan University
ClinicalTrials.gov Identifier:
NCT04127929
Other Study ID Numbers:
  • 280486
First Posted:
Oct 16, 2019
Last Update Posted:
Oct 16, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Zeynep Buket Kaynar, Principal Investigator, Okan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2019