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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01567514
Enrollment
53
Registered
2012-03-30
Start date
2008-03-31
Completion date
2011-03-31
Last updated
2012-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

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

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.

Interventions

PROCEDUREGlass ionomer cement lining

Resin-modified glass ionomer lining

Sponsors

University of Melbourne
CollaboratorOTHER
Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Deep dental caries on occlusal surfaces of molar teeth

Exclusion criteria

* Shallow and moderate-depth caries * Caries exposed pulp

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pulpal complications2 yearsSigns and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026