Treatments of the Necrosed Immature Teeth (REV)

Randomized Comparative Test Multicentric, Forward-looking Single-blind, Between a Reference Technique and an Innovative Technic.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02064517

Enrollment

Registered

2014-02-17

Start date

2014-10-31

Completion date

2020-06-10

Last updated

2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical and Radiographic Success in 24 Months

Keywords

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

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.

Interventions

DEVICEMTA

Creation of a barrier apicale in the MTA

DEVICEHydroxide of calcium

Revascularisation pulpaire with some hydroxide of calcium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Clinical and radiographic success	3-6 months	Clinical and radiographic success in 3 months, 6 months, 12 months and 18 months
Return of the pulpaire sensibility	3-6 months	Test of thermal and electric sensibility
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
Appearance of complications (dyschromie dental)	3-6 months	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026