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

This study has been completed.
Sponsor:
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01567514
First received: March 28, 2012
Last updated: March 29, 2012
Last verified: March 2012
History of Changes

March 28, 2012
March 29, 2012
March 2008
March 2011   (final data collection date for primary outcome measure)
Postoperative pulpal complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Signs and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing.
Same as current
Complete list of historical versions of study NCT01567514 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dental Caries
Procedure: Glass ionomer cement lining
Resin-modified glass ionomer lining
Other Name: Vitrebond (3M ESPE, St. Paul, MN, USA)
  • Active Comparator: Glass-ionomer cement lining
    Presence of glass-ionomer cement lining in posterior resin composite restorations.
    Intervention: Procedure: Glass ionomer cement lining
  • No Intervention: No glass-ionomer cement lining
    Absence of glass-ionomer cement lining in posterior resin composite restorations
    Intervention: Procedure: Glass ionomer cement lining
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria:

  • Shallow and moderate-depth caries
  • Caries exposed pulp
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01567514
MU-IRB 2008/269.3110
Yes
Mahidol University
Mahidol University
University of Melbourne
Study Director: Emeritus Prof. Harold Messer, Ph.D. University of Melbourne
Mahidol University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP