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Completed

NCT Number: NCT01567514

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry, Mahidol University

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Deep dental caries on occlusal surfaces of molar teeth

Exclusion criteria

  • Shallow and moderate-depth caries
  • Caries exposed pulp

Treatment and study plan

Glass ionomer cement lining

Procedure

Resin-modified glass ionomer lining

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

Primary outcomes

  1. Postoperative pulpal complications

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • University of Melbourne

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 30, 2012
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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