Treatments of the Necrosed Immature Teeth (REV)

NCT02064517 | Terminated Phase 2 DMC

• 2 other identifiers: 29BRC12.0131Revascularisation pulpaire
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

Clinical and Radiographic Success in 24 Months

Keywords

Necrosed Immature monoradicular Teeth , Revascularisation pulpar, MTA apical barrier, Clinical and radiographic success

Outcome Measures

Primary Outcomes (1)

• Followed in 24 months

  Clinical and radiological follow-up in 24 months

  24 months

Secondary Outcomes (4)

• Clinical and radiographic success

  3-6 months

• Return of the pulpaire sensibility

  3-6 months

• Obtaining of a closure apicale and of an increase of length and thickness of radiculaires walls

  3-6 months

• Appearance of complications (dyschromie dental)

  3-6 months

Study Arms (2)

Conventional technique

PLACEBO COMPARATOR

Apical MTA barrier

Device: MTA

Revascularisation pulpaire

EXPERIMENTAL

hydroxide of calcium

Device: Hydroxide of calcium

Interventions

MTA DEVICE

Creation of a barrier apicale in the MTA

Conventional technique

Hydroxide of calcium DEVICE

Revascularisation pulpaire with some hydroxide of calcium

Revascularisation pulpaire

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients presenting one or monoradicular immature definitive several teeth ( open apex) with a pulpar necrosis,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (3)

CHRU de Brest - Pôle Organe des Sens

Brest, 29609, France

Location

Hôtel Dieu

Nantes, 44000, France

Location

CHU de Rennes

Rennes, 35000, France

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: October 1, 2014
• Primary Completion: June 6, 2018
• Study Completion: June 10, 2020
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

FR (3)