A Clinical Assessment of Glass Carbomer Cement

March 5, 2018 updated by: Sumaya Nouri, King Abdulaziz University

A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.

This study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. Teeth will be randomly assigned to one of the three restoration groups and the restorations will be evaluated clinically and radiographically every six months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from traditional glass ionomer cement (GIC) and contains nano-sized powder particles of hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties and better bonding to dentin, in addition to continues fluoride release.

The study is a randomized controlled clinical trial where teeth will be randomly assigned to one of the three restoration groups.

Following medical and dental history, bilateral bitewing radiographs will be taken for each patient to assess the presence of proximal lesions. Suitable teeth will then be randomly assigned to one of the restoration groups. A single operator using local anesthesia and rubber dam isolation will then prepare standardized Class II cavities and place the designated restorations according to the manufacturer's instructions.

The quality of the 3 types of restorations will be clinically evaluated at baseline and every six months for color match, marginal discoloration, anatomic form, marginal adaptation, and secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will be performed by 2 calibrated examiners.

Following placement of the restorations, bitewing radiographs will be taken to evaluate the restorations and will be repeated every six months for detection of recurrent caries.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • One proximal lesion in a primary molar.
  • Radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin.
  • Proximal contact with adjacent healthy or restored teeth.
  • Occlusal contact with opposing healthy or restored teeth.
  • No indication for pulp therapy or other restorative treatment.
  • A predicted survival until exfoliation of 2 years.

Exclusion Criteria:

  • Radiographic evidence of caries extending into the inner half of dentin.
  • No proximal contact with adjacent healthy or restored teeth.
  • No occlusal contact with opposing healthy or restored teeth.
  • Tooth indicated for pulp therapy or other restorative treatment.
  • A predicted survival until exfoliation of less than 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glass Carbomer Cement
GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands
Other: Glass Carbomer Cement
Restoration of proximal lesions in primary molars using glass carbomer cement
Other Names:
  • GCP Glass Fill
  • Hydroxyapatite enhance glass ionomer cement
Active Comparator: Resin Modified Glass Ionomer Cement
GC Fuji II LC Capsule, GC International, Tokyo, Japan
Other: Resin Modified Glass Ionomer Cement
Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
Other Names:
  • GC Fuji II LC Capsule
Active Comparator: Composite Resin
Filtek Z250, 3M ESPE, St Paul, MN, USA
Other: Composite Resin
Restoration of proximal lesions in primary molars using composite resin.
Other Names:
  • Filtek Z250

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
Time Frame: 2 Years
the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Investigators

  • Study Chair: Najlaa Alamoudi, MSc, DSc, King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 21, 2017

First Submitted That Met QC Criteria

January 21, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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