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

NCT ID: NCT01567514

Last Updated: 2012-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Dental Caries

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Glass-ionomer cement lining

Presence of glass-ionomer cement lining in posterior resin composite restorations.

Group Type ACTIVE_COMPARATOR

Glass ionomer cement lining

Intervention Type PROCEDURE

Resin-modified glass ionomer lining

No glass-ionomer cement lining

Absence of glass-ionomer cement lining in posterior resin composite restorations

Group Type NO_INTERVENTION

Glass ionomer cement lining

Intervention Type PROCEDURE

Resin-modified glass ionomer lining

Interventions

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Glass ionomer cement lining

Resin-modified glass ionomer lining

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria

* Shallow and moderate-depth caries
* Caries exposed pulp
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Melbourne

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emeritus Prof. Harold Messer, Ph.D.

Role: STUDY_DIRECTOR

University of Melbourne

Locations

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Faculty of Dentistry, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MU-IRB 2008/269.3110

Identifier Type: -

Identifier Source: org_study_id