Clinical and Radiographic Success in 24 MonthsPhase 2NCT02064517
Treatments of the Necrosed Immature Teeth (REV)
A Phase 2 study testing MTA and Hydroxide of calcium in people with Clinical and Radiographic Success in 24 Months, run by University Hospital, Brest at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Clinical and Radiographic Success in 24 Months
- What is being tested?
- MTA and Hydroxide of calcium
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2014to 10 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Brest - Pôle Organe des Sens
Brest, 29609
Hôtel Dieu
Nantes, 44000
CHU de Rennes
Rennes, 35000
About this study
Official title: Randomized Comparative Test Multicentric, Forward-looking Single-blind, Between a Reference Technique and an Innovative Technic.
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.
- Being tested
- MTA, Hydroxide of calcium
- Keywords
- Necrosed Immature monoradicular Teeth , Revascularisation pulpar, MTA apical barrier, Clinical and radiographic success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTADevice
Creation of a barrier apicale in the MTA
Hydroxide of calciumDevice
Revascularisation pulpaire with some hydroxide of calcium
| Study group | Role | What they receive |
|---|---|---|
| Conventional technique | Placebo comparator | Apical MTA barrier Receives: Device: MTA |
| Revascularisation pulpaire | Experimental | hydroxide of calcium Receives: Device: Hydroxide of calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Followed in 24 months
Clinical and radiological follow-up in 24 months
Measured: 24 months
Secondary outcomes (4)
Clinical and radiographic success
Clinical and radiographic success in 3 months, 6 months, 12 months and 18 months
Measured: 3-6 months
Return of the pulpaire sensibility
Test of thermal and electric sensibility
Measured: 3-6 months
Obtaining of a closure apicale and of an increase of length and thickness of radiculaires walls
radiographies with an angulateur and an abutment of repositioning
Measured: 3-6 months
Appearance of complications (dyschromie dental)
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startOct 2014
- Primary completion6 Jun 2018
- Study completion10 Jun 2020
Why it stopped: Lake of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical and Radiographic Success in 24 MonthsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064517
- Sponsor's protocol ID
- 29BRC12.0131
- Other IDs
- Revascularisation pulpaire
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2014
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Test Multicentric, Forward-looking Single-blind, Between a Reference Technique and an Innovative Technic.
- ClinicalTrials.gov ID
- NCT02064517
- Acronym / sponsor ID
- 29BRC12.0131
- Keywords
- Necrosed Immature monoradicular Teeth , Revascularisation pulpar, MTA apical barrier, Clinical and radiographic success
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lake of inclusion
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional technique | Placebo comparator | Device: MTAApical MTA barrier |
| Revascularisation pulpaire | Experimental | Device: Hydroxide of calciumhydroxide of calcium |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTACreation of a barrier apicale in the MTA | Device | Conventional technique |
| Hydroxide of calciumRevascularisation pulpaire with some hydroxide of calcium | Device | Revascularisation pulpaire |
Primary outcome
Followed in 24 months
Time frame: 24 months
Clinical and radiological follow-up in 24 months
4 secondary outcomes
Clinical and radiographic success
Time frame: 3-6 months
Return of the pulpaire sensibility
Time frame: 3-6 months
Obtaining of a closure apicale and of an increase of length and thickness of radiculaires walls
Time frame: 3-6 months
Appearance of complications (dyschromie dental)
Time frame: 3-6 months
Results and safety
The study was stopped early (reason given: Lake of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTA and Hydroxide of calcium in people with Clinical and Radiographic Success in 24 Months, run by University Hospital, Brest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lake of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Followed in 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.