A 2-year Clinical Study on Postoperative Pulpal Complications Arising From the Absence of a Glass-ionomer Lining in Deep Occlusal Resin Composite Restorations
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Postoperative pulpal complications
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Deep dental caries on occlusal surfaces of molar teeth
Exclusion Criteria
- •Shallow and moderate-depth caries
- •Caries exposed pulp
Outcomes
Primary Outcomes
Postoperative pulpal complications
Time Frame: 2 years
Signs and symptoms (subjective/objective) of pulpal \& periapical diseases. Response to electrical pulp testing.
Secondary Outcomes
No secondary outcomes reported