NCT01567514

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

March 28, 2012

Last Update Submit

March 29, 2012

Conditions

Dental Caries

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Postoperative pulpal complications

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

    2 years

Study Arms (2)

Glass-ionomer cement lining

ACTIVE COMPARATOR

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

Procedure: Glass ionomer cement lining

No glass-ionomer cement lining

NO INTERVENTION

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

Procedure: Glass ionomer cement lining

Interventions

Glass ionomer cement liningPROCEDURE

Resin-modified glass ionomer lining

Also known as: Vitrebond (3M ESPE, St. Paul, MN, USA)
Glass-ionomer cement liningNo glass-ionomer cement lining

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Deep dental caries on occlusal surfaces of molar teeth

You may not qualify if:

  • Shallow and moderate-depth caries
  • Caries exposed pulp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mahidol University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Fuji glass-ionomer lining cementVitrabond

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Emeritus Prof. Harold Messer, Ph.D.

    University of Melbourne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

March 30, 2012

Study Start

March 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

TH(1)