Postoperative Pulpal Complications in Posterior Resin Com... | NCT01567514

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

NCT01567514

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Mar 30, 2012Estimated

Enrollment

53Actual

Phase

Phase 4

Conditions

Dental Caries

Interventions

Glass ionomer cement lining

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Mar 28, 2012

First Submission Date that Met QC Criteria

Mar 29, 2012

First Posted Date

Mar 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2012

Last Update Posted Date

Mar 30, 2012Estimated

Name	Class
University of Melbourne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Glass ionomer cement lining	Procedure	Resin-modified glass ionomer lining	Glass-ionomer cement lining No glass-ionomer cement lining

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pulpal complications	Signs and symptoms (subjective/objective) of pulpal & periapical diseases. Response to electrical pulp testing.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria:

Shallow and moderate-depth caries
Caries exposed pulp

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emeritus Prof. Harold Messer, Ph.D.	University of Melbourne	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry, Mahidol University		Bangkok			Thailand

Type	Date	Date Unknown
Release	Sep 18, 2016
Reset	Nov 4, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 18, 2016			Nov 4, 2016

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C084541	Fuji glass-ionomer lining cement
C067790	Vitrabond

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided