Alternative Treatment of Deep Carious Lesions Based on Bi... | NCT00973089

Studies
Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

NCT00973089

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Aug 19, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Caries, Dental

Interventions

Incomplete caries removal in primary teeth

Countries

Israel

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruiting or enrolling participants has halted prematurely and will not resume

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Sep 6, 2009

First Submission Date that Met QC Criteria

Sep 6, 2009

First Posted Date

Sep 9, 2009Estimated

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

Aug 18, 2015

Last Update Posted Date

Aug 19, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Moti Moskovitz, Clinical Senior Lecturer, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

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 evaluate the success rate of alternative treatment of deep carious lesions in asymptomatic primary teeth with no clinical nor radiographic signs of pulpal inflammation. The treatment includes leaving a thin layer of caries that is present near the pulp chamber and includes liner placement and tooth sealing. This alternative treatment is to be compared with the treatment provided today to these teeth, which includes complete removal of caries and probably includes pulpotomy and wide preparation of the tooth. The study also evaluates the cost-effectiveness of both methods of treatment of deep carious lesions.

Detailed Description

The treatment provided today for deep carious lesions in deciduous teeth is complete removal of the soft caries, that can lead to a wide preparation and need of tooth pulpotomy if the caries reaches to the pulp chamber, even if the tooth is asymptomatic and shows no signs of pulpal inflammation (neither clinically nor radiographically). According to a number of recent evidence based researches, and only in selected cases, dentists were able to preserve the vitality of the pulp without complete removal of the caries present near the pulp chamber. A thin layer of caries near the pulp chamber is left, and a liner is placed (conservative treatment). The carious process is stopped when the tooth is sealed, and thus the tooth is saved without engaging with pulpotomy and wide preparation of the tooth. The purpose of this study is to evaluate the success rate of the conservative treatment of deep carious lesions versus the treatment provided today that includes complete removal of caries and probably includes pulpotomy and wide preparation of the tooth. The study also evaluates the cost-effectiveness of both methods of treatment of deep carious lesions.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Complete caries removal	No Intervention	Control group
Incomplete caries removal	Other	Test group	Other: Incomplete caries removal in primary teeth

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Incomplete caries removal in primary teeth	Other	Comparison between the success rate and cost-effectiveness of complete caries removal in treatment of deep carious lesions that might include wide preparations and involve pulpotomy versus incomplete removal of caries and avoiding pulp treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The success of the alternative treatment of the deep carious lesion.		Half annually for three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy children
Patient's age is 5-8 years old at the time of the treatment
Primary molars presenting with deep carious lesions
Carious lesion reaching the inner half of the dentin,with absence of periapical or interradicular alterations as detected by radiographic examination.
Absence of spontaneous pain

Exclusion Criteria:

Subjects that are not ASA I
Lack of cooperation
Clinical or radiographic signs of pathology

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18519994	Background	Thompson V, Craig RG, Curro FA, Green WS, Ship JA. Treatment of deep carious lesions by complete excavation or partial removal: a critical review. J Am Dent Assoc. 2008 Jun;139(6):705-12. doi: 10.14219/jada.archive.2008.0252.

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases