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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567514
First Posted: March 30, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
Mahidol University
March 28, 2012
March 30, 2012
October 12, 2017
March 2008
March 2011   (Final data collection date for primary outcome measure)
Postoperative pulpal complications [ Time Frame: 2 years ]
Signs and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing.
Same as current
No Changes Posted
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 (Participant, 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
Sexes Eligible for Study: All
18 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01567514
MU-IRB 2008/269.3110
Yes
Not Provided
Not Provided
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