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
  Purpose

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.


Condition Intervention Phase
Dental Caries
Procedure: Glass ionomer cement lining
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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.


Enrollment: 53
Study Start Date: March 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glass-ionomer cement lining
Presence of glass-ionomer cement lining in posterior resin composite restorations.
Procedure: Glass ionomer cement lining
Resin-modified glass ionomer lining
Other Name: Vitrebond (3M ESPE, St. Paul, MN, USA)
No Intervention: No glass-ionomer cement lining
Absence of glass-ionomer cement lining in posterior resin composite restorations
Procedure: Glass ionomer cement lining
Resin-modified glass ionomer lining
Other Name: Vitrebond (3M ESPE, St. Paul, MN, USA)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria:

  • Shallow and moderate-depth caries
  • Caries exposed pulp
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567514

Locations
Thailand
Faculty of Dentistry, Mahidol University
Bangkok, Thailand
Sponsors and Collaborators
Mahidol University
University of Melbourne
Investigators
Study Director: Emeritus Prof. Harold Messer, Ph.D. University of Melbourne
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01567514     History of Changes
Other Study ID Numbers: MU-IRB 2008/269.3110
Study First Received: March 28, 2012
Last Updated: March 29, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Deep occlusal caries restored with resin composite
on Pit and Fissure Surface Penetrating Into Dentin

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014