Treatments of the Necrosed Immature Teeth (REV) | NCT02064517

Studies
Treatments of the Necrosed Immature Teeth (REV)

NCT02064517

Sponsor

University Hospital, Brest

Status

Terminated

Last Update Posted

Feb 6, 2025Actual

Enrollment

16Actual

Phase

Phase 2

Conditions

Clinical and Radiographic Success in 24 Months

Interventions

MTA
Hydroxide of calcium

Countries

France

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

ID	Type	Description	Link
Revascularisation pulpaire

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lake of inclusion

Expanded Access Info

Start Date

Oct 2014Actual

Primary Completion Date

Jun 6, 2018Actual

Completion Date

Jun 10, 2020Actual

First Submitted Date

Feb 14, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 17, 2014Estimated

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

Feb 4, 2025

Last Update Posted Date

Feb 6, 2025Actual

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

Estimate if the technique of revascularisation pulpaire (with some hydroxide of calcium) allows to obtain a better forecast of preservation of the tooth without complication than the conventional technique with the creation of an apicale barrier in the MTA in 24 months.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional technique	Placebo Comparator	Apical MTA barrier	Device: MTA
Revascularisation pulpaire	Experimental	hydroxide of calcium	Device: Hydroxide of calcium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MTA	Device	Creation of a barrier apicale in the MTA	Conventional technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Followed in 24 months	Clinical and radiological follow-up in 24 months	24 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical and radiographic success	Clinical and radiographic success in 3 months, 6 months, 12 months and 18 months	3-6 months
Return of the pulpaire sensibility	Test of thermal and electric sensibility

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients presenting one or monoradicular immature definitive several teeth ( open apex) with a pulpar necrosis,
6-year-old patients in 17 years the parents(relatives) of which agree to give a lit(enlightened) written consent or patients of more than 18 years old.

Exclusion Criteria:

general order: any pathology or treatment(processing) dissuading a treatment(processing) endodontic (patients at risk of infectious endocarditis) or pulling(entailing) an immunosuppression (diabetes, HIV, immunosuppresseurs treatments(processings) post-transplant, long-term corticoids, chemotherapies), allergy known about the used, antecedent products of cervico-facial radiotherapy, presenting subject of the communications problems, the pregnancy and the feeding.
local order: generalized periodontal disease or superior located(localized) periodontal pocket in 3mm, crack or fracture(split) radiculaire, radiculaire reduction of the necrosed immature tooth

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest - Pôle Organe des Sens		Brest		29609	France
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