Dental Pulp NecrosisPhase 3APEXMTANCT00472173
Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth
A Phase 3 study testing Mineral Trioxide Aggregate and Calcium hydroxide in people with Dental Pulp Necrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pulp necrosis is one of the main complication of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.The… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Dental Pulp Necrosis
- What is being tested?
- Mineral Trioxide Aggregate and Calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to May 2011
- Phase
- Phase 3
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Indication of apexification treatment of an anterior immature tooth
- Patients aged 6 to 18
- Enlightened agreement of the patient and his/her legal representatives
- Prerequisite medical examination
Who cannot join
- General disease
- diabetes
- immunosuppression of whatever origin (AIDS, drugs, …)
- severe asthma
- chronical disease requiring treatment
- eating disorders (anorexia, bulimia, malnutrition, …) Oral disease
Show all 9Show fewer
- periodontal disease
- Administration of corticoids in a period of 3 months preceding the inclusion
- Patient with no social security cover
Trial locations and contacts
1 site in 1 country.
About this study
Pulp necrosis is one of the main complication of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.The aim of this study is to compare the efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the reference treatment based on calcium hydroxide repeated stimulations.
Read the detailed description
36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the study (inclusion period: 12 months). These patients will be randomly divided into two groups: one treated with MTA®, and the other one with calcium hydroxide. For each patient, the total duration of the study will be 12 months. Recalls will be performed at 15 and 21 days and then at 3, 6 and 12 months to assess by clinical and X-ray exams the main success criterion: presence of a calcified apical barrier or not. Additional criterions such as presence of clinical symptoms or not, apical morphology and depth of this apical barrier will be observed. This randomised prospective therapeutic study will allow to assess the ability of MTA® inducing apexification of a non vital immature tooth. Furthermore, it will be possible to compare for both materials the kinetics of clinical symptoms disappearance and the morphology and depth of apices.
- Conditions
- Dental Pulp Necrosis
- Being tested
- Mineral Trioxide Aggregate, Calcium hydroxide
- Keywords
- Apexification, Pulp necrosis, Calcium hydroxide, MTA, pulp necrosis of an anterior immature tooth
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral Trioxide AggregateDrug
Apexification treatment of the tooth with Mineral Trioxide Aggregate
Calcium hydroxideDrug
Apexification treatment of the tooth with Calcium hydroxide
| Study group | Role | What they receive |
|---|---|---|
| Calcium hydroxide | Active comparator | Not described Receives: Drug: Calcium hydroxide |
| MTA | Experimental | Not described Receives: Drug: Mineral Trioxide Aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months
Measured: 30 days
Secondary outcomes (1)
Additional criterions :- presence of clinical symptoms or not- apical morphology - depth of this apical barrier At 3, 6 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp NecrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques Lasfargues, Dentist PhD, Principal investigator, Hôpital Bretonneau - ParisRaphaël SERREAU, MD, PhD, Study director, URC Paris Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472173
- Sponsor's protocol ID
- P06236
- Acronym
- APEXMTA
- Status last verified
- Mar 2026
- First submitted
- 10 May 2007
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Beslot-Neveu A, Bonte E, Baune B, Serreau R, Aissat F, Quinquis L, Grabar S, Lasfargues JJ. Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: study protocol for a randomized controlled trial. Trials. 2011 Jul 13;12:174. doi: 10.1186/1745-6215-12-174.
PubMed 21752247
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth
- ClinicalTrials.gov ID
- NCT00472173
- Acronym / sponsor ID
- APEXMTA / P06236
- Conditions
- Dental Pulp Necrosis
- Keywords
- Apexification, Pulp necrosis, Calcium hydroxide, MTA, pulp necrosis of an anterior immature tooth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- May 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 May 2007 (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.
Pulp necrosis is one of the main complication of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.The aim of this study is to compare the efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the reference treatment based on calcium hydroxide repeated stimulations.
Detailed description
36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the study (inclusion period: 12 months). These patients will be randomly divided into two groups: one treated with MTA®, and the other one with calcium hydroxide. For each patient, the total duration of the study will be 12 months. Recalls will be performed at 15 and 21 days and then at 3, 6 and 12 months to assess by clinical and X-ray exams the main success criterion: presence of a calcified apical barrier or not. Additional criterions such as presence of clinical symptoms or not, apical morphology and depth of this apical barrier will be observed. This randomised prospective therapeutic study will allow to assess the ability of MTA® inducing apexification of a non vital immature tooth. Furthermore, it will be possible to compare for both materials the kinetics of clinical symptoms disappearance and the morphology and depth of apices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium hydroxide | Active comparator | Drug: Calcium hydroxide |
| MTA | Experimental | Drug: Mineral Trioxide Aggregate |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Indication of apexification treatment of an anterior immature tooth
- Patients aged 6 to 18
- Enlightened agreement of the patient and his/her legal representatives
- Prerequisite medical examination
Key exclusion criteria (9 listed)
- General disease
- diabetes
- immunosuppression of whatever origin (AIDS, drugs, …)
- severe asthma
- chronical disease requiring treatment
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 |
|---|---|---|
| Mineral Trioxide AggregateApexification treatment of the tooth with Mineral Trioxide Aggregate | Drug | MTA |
| Calcium hydroxideApexification treatment of the tooth with Calcium hydroxide | Drug | Calcium hydroxide |
Primary outcome
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months
Time frame: 30 days
1 secondary outcome
Additional criterions :- presence of clinical symptoms or not- apical morphology - depth of this apical barrier At 3, 6 and 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 21752247Beslot-Neveu A, Bonte E, Baune B, Serreau R, Aissat F, Quinquis L, Grabar S, Lasfargues JJ. Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: study protocol for a randomized controlled trial. Trials. 2011 Jul 13;12:174. doi: 10.1186/1745-6215-12-174.
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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.
Jean-Jacques Lasfargues, Dentist PhD principal investigator
Hôpital Bretonneau - Paris
Raphaël SERREAU, MD, PhD study director
URC Paris Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mineral Trioxide Aggregate and Calcium hydroxide in people with Dental Pulp Necrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00472173, which also lists 1 linked publication.
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 4 Mar 2026.