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NCT01567514 Clinical Trial

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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01567514
Other study ID # MU-IRB 2008/269.3110
Secondary ID
Status Completed
Phase Phase 4
First received March 28, 2012
Last updated March 29, 2012
Start date March 2008
Est. completion date March 2011

Study information
Verified date March 2012
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria:

- Shallow and moderate-depth caries

- Caries exposed pulp

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Glass ionomer cement lining
Resin-modified glass ionomer lining

Locations
Country Name City State
Thailand Faculty of Dentistry, Mahidol University Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Mahidol University University of Melbourne

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pulpal complications Signs and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing. 2 years
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