Treatments of the Necrosed Immature Teeth (REV)

Phase 2

Terminated

• Conditions: Clinical and Radiographic Success in 24 Months
• Interventions: Device: MTA; Device: Hydroxide of calcium

• Registration Number: NCT02064517
• Lead Sponsor: University Hospital, Brest

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 available

Study Timeline

• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-10
• Primary Completion: 2018-06-06
• Study Completion: 2020-06-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional technique	MTA	Apical MTA barrier
Revascularisation pulpaire	Hydroxide of calcium	hydroxide of calcium

Primary Outcome Measures

Name	Time	Method
Followed in 24 months	24 months	Clinical and radiological follow-up in 24 months

Secondary Outcome Measures

Name	Time	Method
Obtaining of a closure apicale and of an increase of length and thickness of radiculaires walls	3-6 months	radiographies with an angulateur and an abutment of repositioning
Clinical and radiographic success	3-6 months	Clinical and radiographic success in 3 months, 6 months, 12 months and 18 months
Appearance of complications (dyschromie dental)	3-6 months
Return of the pulpaire sensibility	3-6 months	Test of thermal and electric sensibility

Trial Locations

Locations (3)

CHRU de Brest - Pôle Organe des Sens; 🇫🇷 Brest, France

Hôtel Dieu; 🇫🇷 Nantes, France

CHU de Rennes; 🇫🇷 Rennes, France