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

Phase 4

Completed

• Conditions: Dental Caries

• Registration Number: NCT01567514
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-03
• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-03-29
• Last Update Submitted: 2012-03-29
• Study First Posted: 2012-03-30
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria

• Shallow and moderate-depth caries
• Caries exposed pulp

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pulpal complications	2 years	Signs and symptoms (subjective/objective) of pulpal \& periapical diseases. Response to electrical pulp testing.

Trial Locations

Locations (1)

Faculty of Dentistry, Mahidol University; 🇹🇭 Bangkok, Thailand