Postoperative Pulpal Complications in Posterior Resin Composite Restorations Without Glass-ionomer Cement Lining

March 29, 2012 updated by: Mahidol University

A 2-year Clinical Study on Postoperative Pulpal Complications Arising From the Absence of a Glass-ionomer Lining in Deep Occlusal Resin Composite Restorations

The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on risk of pulpal complications in deep occlusal cavities with resin-based restorations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty three patients aged 18-30 years who had one or two deep occlusal carious lesions (≥ 3 mm in depth) in molars were recruited. Dental caries was removed and the prepared cavity was restored with resin composite using one of two restorative procedures: (1) without GIC lining; (2) with (resin-modified) GIC lining. Restored teeth were evaluated for any pulpal complications (subjective symptoms, objective signs or loss of tooth vitality) at one month (baseline), one year and two years after restoration.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • faculty of dentistry, Mahidol university

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria:

  • Shallow and moderate-depth caries
  • Caries exposed pulp

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glass-ionomer cement lining
Presence of glass-ionomer cement lining in posterior resin composite restorations.
Procedure: Glass ionomer cement lining
Resin-modified glass ionomer lining
Other Names:
  • Vitrebond (3M ESPE, St. Paul, MN, USA)
No Intervention: No glass-ionomer cement lining
Absence of glass-ionomer cement lining in posterior resin composite restorations
Procedure: Glass ionomer cement lining
Resin-modified glass ionomer lining
Other Names:
  • Vitrebond (3M ESPE, St. Paul, MN, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulpal complications
Time Frame: 2 years
Signs and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing.
2 years

Collaborators and Investigators

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

Sponsor

Mahidol University

Collaborators

University of Melbourne

Investigators

  • Study Director: Emeritus Prof. Harold Messer, Ph.D., University of Melbourne

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

March 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 29, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-IRB 2008/269.3110

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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