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

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Glass ionomer cement lining

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Deep occlusal caries restored with resin composite, on Pit and Fissure Surface Penetrating Into Dentin

Eligibility Criteria

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

Inclusion Criteria:

Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria:

Shallow and moderate-depth caries
Caries exposed pulp

Sites / Locations

Faculty of Dentistry, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Glass-ionomer cement lining

No glass-ionomer cement lining

Arm Description

Presence of glass-ionomer cement lining in posterior resin composite restorations.

Absence of glass-ionomer cement lining in posterior resin composite restorations

Outcomes

Primary Outcome Measures

Postoperative pulpal complications

Signs and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing.

Secondary Outcome Measures

Full Information

NCT ID

NCT01567514

First Posted

March 28, 2012

Last Updated

March 29, 2012

Sponsor

Mahidol University

Collaborators

University of Melbourne

1. Study Identification

Unique Protocol Identification Number

NCT01567514

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

Collaborators

University of Melbourne

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

Deep occlusal caries restored with resin composite, on Pit and Fissure Surface Penetrating Into Dentin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glass-ionomer cement lining

Arm Type

Active Comparator

Arm Description

Presence of glass-ionomer cement lining in posterior resin composite restorations.

Arm Title

No glass-ionomer cement lining

Arm Type

No Intervention

Arm Description

Absence of glass-ionomer cement lining in posterior resin composite restorations

Intervention Type

Procedure

Intervention Name(s)

Glass ionomer cement lining

Other Intervention Name(s)

Vitrebond (3M ESPE, St. Paul, MN, USA)

Intervention Description

Resin-modified glass ionomer lining

Primary Outcome Measure Information:

Title

Postoperative pulpal complications

Description

Signs and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Deep dental caries on occlusal surfaces of molar teeth Exclusion Criteria: Shallow and moderate-depth caries Caries exposed pulp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emeritus Prof. Harold Messer, Ph.D.

Organizational Affiliation

University of Melbourne

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry, Mahidol University

City

Bangkok

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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