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Investigation of Glass Carbomer Performance

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Restoration of cavities using glass carbomer material (GCP Dental)
Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring glass ionomer, composite, clinical

Eligibility Criteria

25 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem vakif university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Glass carbomer

Tokuyama Estelite Posterior

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2019
Last Updated
October 15, 2019
Sponsor
Okan University
Collaborators
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04127929
Brief Title
Investigation of Glass Carbomer Performance
Official Title
12-Month Clinical Performance Evaluation of a Current Glass Carbomer Restorative System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 9, 2017 (Actual)
Primary Completion Date
September 16, 2017 (Actual)
Study Completion Date
September 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University
Collaborators
Bezmialem Vakif University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
glass ionomer, composite, clinical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glass carbomer
Arm Type
Active Comparator
Arm Title
Tokuyama Estelite Posterior
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Restoration of cavities using glass carbomer material (GCP Dental)
Intervention Description
Detection of caries then restoration of cavities
Intervention Type
Other
Intervention Name(s)
Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)
Intervention Description
Detection of caries then restoration of cavities
Primary Outcome Measure Information:
Title
Evaluation of criterias
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Evaluation of criterias
Description
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
Time Frame
6-months
Other Pre-specified Outcome Measures:
Title
Evaluations of criterias
Description
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.
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Buket Kaynar, Dr
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem vakif university
City
Istanbul
State/Province
Fatih
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
12 months

Learn more about this trial

Investigation of Glass Carbomer Performance

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