Inflammatory Pulp Diseases Related to Carious TeethPULPSAVENCT02727088
Pulpotomy vs Pulpectomy Outcome.
A study testing Pulpotomy and Pulpectomy in people with Inflammatory Pulp Diseases Related to Carious Teeth, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Epidemiological data show a significant rate of failure of endodontic treatment of 20 to 50% worldwide, probably directly related to the difficulty of the procedure. A successful pulpotomy allows the preservation of a vital radicular pulp into the root canal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Pulp Diseases Related to Carious Teeth
- What is being tested?
- Pulpotomy and Pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ( ≥ 18 years old),
- Signed a written informed consent,
- Mature permanent teeth, presenting with either:
- any indication of pulpectomy on asymptomatic pulp,
- pulp exposure during treatment of deep caries,
- reversible and irreversible pulpitis.
Show all 29Show fewer
- Access to permanent restorative treatment in a reasonable delay (1 month) after treatment.
- Patient has a health coverage (affiliation to social security system or similar, excluding AME (Aide Médicale d'Etat)
- Non-inclusion criteria :
- General:
- Patient deprived of liberty or under legal protection measure
- Pregnant or nursing (lactating) woman or who does not apply effective contraception during the study
- Impossible or dubious follow-up;
- Any general contra-indication to endodontic procedures;
- Compromised general prognosis;
- Immunodeficiency;
- Anticoagulant and/or antiplatelet drug therapy
- Participation to another clinical trial (to be discussed with the other trial's investigators);
- Impossible or dubious post-procedure restorative treatment.
- Local (pertaining to the candidate tooth):
- Compromised local prognosis (e. g. trauma, periodontal disease);
- Treatment plan including avulsion;
- Treatment plan including radicular post placement;
- Internal or external root resorption;
- Preoperative evidence of pulp necrosis;
- Presence of pulp stones into the pulp chamber clearly visible on the preoperative radiography.
- Extemporaneous exclusion criteria:
- Peroperative clinical evidence of complete or partial pulp necrosis (in one root at least on multirooted teeth);
- Impossibility to control haemorrhage of the pulp on one canal at least.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Randomized Clinical Comparison of Pulp Chamber Pulpotomy and Root Canal Treatment (Pulpectomy) as a Permanent Endodontic Treatment of Mature Permanent Teeth: Analysis of Relationship Between Inflammation Biomarkers Pulpal Expression and Treatment Outcome
Epidemiological data show a significant rate of failure of endodontic treatment of 20 to 50% worldwide, probably directly related to the difficulty of the procedure. A successful pulpotomy allows the preservation of a vital radicular pulp into the root canal. The presence of a biological tissue into the root canal is definitely more efficient than a "complete" filling with an inert material. It has been shown on animal and human studies that this pulp stump in contact with the biomaterial is able to regenerate a dentinal plug, with the same architecture as physiologic dentin.
Primary objective : To compare the success rates of root canal treatment (reference) and conservative treatment (pulpotomy) for treating inflamed dental pulp on permanent mature teeth.
Read more
Secondary objectives : (1) To describe the clinical and biological prognostic factors of these two treatments; (2) to assess the additional value of biomarkers expression levels as a prognostic tool for clinical decision making (radical vs. conservative treatment); (3) to assess the impact of treatment on post-procedural pain.
This trial aims to demonstrate the non-inferiority of conservative pulpal treatment over endodontic treatment.
Patients consulting in one of the seven study centers, presenting one of the indications retained for the trial and giving written informed consent will receive the treatment (endodontic treatment or conservative treatment) allocated by randomization (stratified over the clinical diagnosis of the pulp status).
The follow up of patients include, a phone call at D15, and visit at 1, 6, 12 and 14 post operative months. Clinical examination and Xrays at 6, 12 and 24 months) will be used to evaluate the success or failure of the treatment.
During the treatment, a sample of pulp tissue will be withdrawn and transferred to a molecular biology laboratory for analysis of inflammation biomarkers. The aim of this part of the sudy is to assess a putative relationship (1) of regulation of biomarkers expression and clinical diagnosis, and (2) of regulation of these biomarkers and success rate of pulpotomy.
Success/failure evaluation:
The primary endpoint is the time to necessity of endodontic reintervention (analysed as a time to failure). This study will use an Intention To Treat analysis as its main assessment ; a secondary assessment accounting for peroperative conversions will assess the practical impact of these conversions. We will distinguish
- Direct failure (means that the failure is directly correlated to the treatment) : the reintervention need is due to the evolution of the treated tooth. This includes delayed onset of desmodontitis, periodontal space enlargement and/or periapical/periradicular radiolucency (PAI>2) demonstrating an infection of the root canal system (filled by either pulpal stump or filling material).
- Indirect failure (means that the cause of the failure is not directly related to the endodontic treatment choice) : any event leading to endodontic reintervention indication NOT caused by radicular infection or restoration failure attributable to inadequate restoration. For example : new need of post-placement for treatment of loss of another tooth, unexpected progression of periodontal disease.
Both these failure modes are of interest for analysis : the direct failure time is an indication if the intrinsic value of a therapy, whereas the gross (direct+indirect) failure time is an indication of its clinical relevance (a good therapy applicable in rare cases may be less interesting than a mediocre but widely applicable one).
Statistical analysis:
The classical methods of descriptive analysis will be used to describe the raw results.
In order to make inferences directly on possible clinical results, this study will be analyzed in a Bayesian framework.
This study has been designed in reference with a frequentist demonstration of non-inferiority.
A non-inferiority trial with first and second species error rates α and β has the same operational characteristics as a superiority (unilateral trial) of error rates alpha and beta, which in turn needs the same study size as a comparison (=bilateral) trial with error rates α and 2β.
The final planned size of the trial is established as follows :
- Ideal plan : a nonparametric comparison (logrank test) fulfilling these goals according to this plan needs 158 patients overall under "perfect information" assumptions (no loss to follow-up, single analysis)
- Loss to follow-up : the expected loss to follow-up will cause about 22% of included patients to drop out of the study before final analysis this leads to include 194 patients overall.
Sequential analysis : since we wish to be able to follow the progress of the study, and to interrupt it if the main goal is reached, we choose to use a sequential analysis. A Pocock scheme needs to increase the sample size by 16% , leading to plan to recruit 226 patients overall.
Read the detailed description
The accepted management for any pulpal intervention on a vital dental pulp is the pulpectomy (ablation of the whole dental pulp, preparation and filling of the whole root canal system, which is difficult and invasive). However, it has been shown that radicular pulp has a reparative potential and interesting immune defence properties. A pulp chamber pulpotomy (ablation of the coronal part of the pulp, easier and less invasive) may therefore be a better alternative. Its feasibility, known on decidual and immature permanent teeth (where it is a routine treatment) has been shown on mature permanent teeth. We aim to prove its non-inferiority to pulpectomy and study its prognostic factors.
Primary objective and primary endpoint:
To compare the success rates of root canal treatment (i.e. pulpectomy, reference treatment) and conservative treatment (pulpotomy) for treating dental pulpal inflammatory disease on permanent teeth, assessed by time to indication of re-treatment (time-to-failure) (primary endpoint). The investigator in charge of the patient proposes a classification of the failure, which must be validated by an adjudication committee.
Secondary objectives and endpoints:
- To assess the impact of treatment on post-procedural pain;
- To describe the clinical prognostic factors of these two treatments;
- To assess the additional value of biomarkers expression levels as a prognostic tool for clinical decision making (pulpectomy vs. pulpotomy).
Study design:
Prospective, comparative, randomized study (randomized clinical trial)
Study population:
Adult patients with indication of pulpal intervention on a permanent mature non-necrosed tooth.
Adjudication committee:
The adjudication committee will review the classification of the failure for each patient, on the basis of data and radiographs and if necessary will submit queries sent to investigator. The adjudication committee will finally classify the failure as direct or indirect.
Sample size and Power consideration:
Maximum of 226 patients, based on analogy with frequentist analysis:
- non-inferiority study, α =0.05, 1- β =0.8;
- expected rate of failure in the control group: 10% /year;
- maximal inferiority margin: hazard ratio=2;
- two years of accrual, one year of follow-up;
- each patient is followed up to the end of study;
- expected loss to follow-up 10%/year:
- loss of power due to interval censorship of clinically silent failure: negligible;
- sequential analysis (Pocock scheme, final test with final critical p=0.03).
Statistical analysis:
Bayesian analysis, analogous to a frequentist non inferiority study (RRmin=2) with α=0.05 and β=0.2
Bayesian modelling of survival of retreatment indication-free, assessing:
- Intergroup differences (Cox proportional hazards model if applicable, parametric modelling otherwise)
- Covariates impact (regression models) Assessment of predictive values of (clinical and biological) covariates.
- Being tested
- Pulpotomy, Pulpectomy
- Keywords
- Dental Pulp Disease, Endodontics, Pulp Capping, Pulpotomy, Pulpectomy
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Conservative pulp management (experimental treatment): ablation of the coronal part of the pulp
PulpectomyProcedure or surgery
Also called root canal treatment (reference treatment)
ablation of the whole dental pulp, preparation and filling of the whole root canal system
| Study group | Role | What they receive |
|---|---|---|
| Pulpectomy : root canal treatment | Active comparator | Pulpectomy : ablation of the whole dental pulp, preparation and filling of the whole root canal system Receives: Procedure: Pulpectomy |
| Pulpotomy : Conservative pulp management | Experimental | Pulpotomy : ablation of the coronal part of the pulp Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the success rates of root canal treatment (pulpectomy, reference) and conservative treatment (pulpotomy)
Time to treatment failure, as assessed by the existence of an indication of re-intervention (with or without contra-indication).
Measured: up to M36
Secondary outcomes (3)
To assess the impact of treatment on post-procedural pain
Acute post-operative pain
Measured: D7
To describe the clinical prognostic factors of these two treatments
Clinical and radiological signs such as pain, maxillary bone lesion, periodontal attachment loss, …
Measured: baseline, M1, M6, M12, M24, M36 and time to re-treatment
To assess the additional value of biomarkers expression levels as a prognostic tool for clinical decision making (pulpectomy vs. pulpotomy).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Pulp Diseases Related to Carious TeethStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital, Nantes University Hospital, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Stéphane SIMON, DDS, Mphil, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727088
- Sponsor's protocol ID
- P140941
- Other IDs
- IDRCB
- Acronym
- PULPSAVE
- Status last verified
- Sep 2016
- First submitted
- 7 Mar 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized Clinical Comparison of Pulp Chamber Pulpotomy and Root Canal Treatment (Pulpectomy) as a Permanent Endodontic Treatment of Mature Permanent Teeth: Analysis of Relationship Between Inflammation Biomarkers Pulpal Expression and Treatment Outcome
- ClinicalTrials.gov ID
- NCT02727088
- Acronym / sponsor ID
- PULPSAVE / P140941
- Keywords
- Dental Pulp Disease, Endodontics, Pulp Capping, Pulpotomy, Pulpectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Rennes University Hospital, Nantes University Hospital, University Hospital, Clermont-Ferrand
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 4 Apr 2016 (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.
Epidemiological data show a significant rate of failure of endodontic treatment of 20 to 50% worldwide, probably directly related to the difficulty of the procedure. A successful pulpotomy allows the preservation of a vital radicular pulp into the root canal. The presence of a biological tissue into the root canal is definitely more efficient than a "complete" filling with an inert material. It has been shown on animal and human studies that this pulp stump in contact with the biomaterial is able to regenerate a dentinal plug, with the same architecture as physiologic dentin.
Primary objective : To compare the success rates of root canal treatment (reference) and conservative treatment (pulpotomy) for treating inflamed dental pulp on permanent mature teeth.
Secondary objectives : (1) To describe the clinical and biological prognostic factors of these two treatments; (2) to assess the additional value of biomarkers expression levels as a prognostic tool for clinical decision making (radical vs. conservative treatment); (3) to assess the impact of treatment on post-procedural pain.
This trial aims to demonstrate the non-inferiority of conservative pulpal treatment over endodontic treatment.
Patients consulting in one of the seven study centers, presenting one of the indications retained for the trial and giving written informed consent will receive the treatment (endodontic treatment or conservative treatment) allocated by randomization (stratified over the clinical diagnosis of the pulp status).
The follow up of patients include, a phone call at D15, and visit at 1, 6, 12 and 14 post operative months. Clinical examination and Xrays at 6, 12 and 24 months) will be used to evaluate the success or failure of the treatment.
During the treatment, a sample of pulp tissue will be withdrawn and transferred to a molecular biology laboratory for analysis of inflammation biomarkers. The aim of this part of the sudy is to assess a putative relationship (1) of regulation of biomarkers expression and clinical diagnosis, and (2) of regulation of these biomarkers and success rate of pulpotomy.
Success/failure evaluation:
The primary endpoint is the time to necessity of endodontic reintervention (analysed as a time to failure). This study will use an Intention To Treat analysis as its main assessment ; a secondary assessment accounting for peroperative conversions will assess the practical impact of these conversions. We will distinguish
- Direct failure (means that the failure is directly correlated to the treatment) : the reintervention need is due to the evolution of the treated tooth. This includes delayed onset of desmodontitis, periodontal space enlargement and/or periapical/periradicular radiolucency (PAI>2) demonstrating an infection of the root canal system (filled by either pulpal stump or filling material).
- Indirect failure (means that the cause of the failure is not directly related to the endodontic treatment choice) : any event leading to endodontic reintervention indication NOT caused by radicular infection or restoration failure attributable to inadequate restoration. For example : new need of post-placement for treatment of loss of another tooth, unexpected progression of periodontal disease.
Both these failure modes are of interest for analysis : the direct failure time is an indication if the intrinsic value of a therapy, whereas the gross (direct+indirect) failure time is an indication of its clinical relevance (a good therapy applicable in rare cases may be less interesting than a mediocre but widely applicable one).
Statistical analysis:
The classical methods of descriptive analysis will be used to describe the raw results.
In order to make inferences directly on possible clinical results, this study will be analyzed in a Bayesian framework.
This study has been designed in reference with a frequentist demonstration of non-inferiority.
A non-inferiority trial with first and second species error rates α and β has the same operational characteristics as a superiority (unilateral trial) of error rates alpha and beta, which in turn needs the same study size as a comparison (=bilateral) trial with error rates α and 2β.
The final planned size of the trial is established as follows :
- Ideal plan : a nonparametric comparison (logrank test) fulfilling these goals according to this plan needs 158 patients overall under "perfect information" assumptions (no loss to follow-up, single analysis)
- Loss to follow-up : the expected loss to follow-up will cause about 22% of included patients to drop out of the study before final analysis this leads to include 194 patients overall.
Sequential analysis : since we wish to be able to follow the progress of the study, and to interrupt it if the main goal is reached, we choose to use a sequential analysis. A Pocock scheme needs to increase the sample size by 16% , leading to plan to recruit 226 patients overall.
Detailed description
The accepted management for any pulpal intervention on a vital dental pulp is the pulpectomy (ablation of the whole dental pulp, preparation and filling of the whole root canal system, which is difficult and invasive). However, it has been shown that radicular pulp has a reparative potential and interesting immune defence properties. A pulp chamber pulpotomy (ablation of the coronal part of the pulp, easier and less invasive) may therefore be a better alternative. Its feasibility, known on decidual and immature permanent teeth (where it is a routine treatment) has been shown on mature permanent teeth. We aim to prove its non-inferiority to pulpectomy and study its prognostic factors.
Primary objective and primary endpoint:
To compare the success rates of root canal treatment (i.e. pulpectomy, reference treatment) and conservative treatment (pulpotomy) for treating dental pulpal inflammatory disease on permanent teeth, assessed by time to indication of re-treatment (time-to-failure) (primary endpoint). The investigator in charge of the patient proposes a classification of the failure, which must be validated by an adjudication committee.
Secondary objectives and endpoints:
- To assess the impact of treatment on post-procedural pain;
- To describe the clinical prognostic factors of these two treatments;
- To assess the additional value of biomarkers expression levels as a prognostic tool for clinical decision making (pulpectomy vs. pulpotomy).
Study design:
Prospective, comparative, randomized study (randomized clinical trial)
Study population:
Adult patients with indication of pulpal intervention on a permanent mature non-necrosed tooth.
Adjudication committee:
The adjudication committee will review the classification of the failure for each patient, on the basis of data and radiographs and if necessary will submit queries sent to investigator. The adjudication committee will finally classify the failure as direct or indirect.
Sample size and Power consideration:
Maximum of 226 patients, based on analogy with frequentist analysis:
- non-inferiority study, α =0.05, 1- β =0.8;
- expected rate of failure in the control group: 10% /year;
- maximal inferiority margin: hazard ratio=2;
- two years of accrual, one year of follow-up;
- each patient is followed up to the end of study;
- expected loss to follow-up 10%/year:
- loss of power due to interval censorship of clinically silent failure: negligible;
- sequential analysis (Pocock scheme, final test with final critical p=0.03).
Statistical analysis:
Bayesian analysis, analogous to a frequentist non inferiority study (RRmin=2) with α=0.05 and β=0.2
Bayesian modelling of survival of retreatment indication-free, assessing:
- Intergroup differences (Cox proportional hazards model if applicable, parametric modelling otherwise)
- Covariates impact (regression models) Assessment of predictive values of (clinical and biological) covariates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpectomy : root canal treatment | Active comparator | Procedure: PulpectomyPulpectomy : ablation of the whole dental pulp, preparation and filling of the whole root canal system |
| Pulpotomy : Conservative pulp management | Experimental | Procedure: PulpotomyPulpotomy : ablation of the coronal part of the pulp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Adult patients ( ≥ 18 years old),
- Signed a written informed consent,
- Mature permanent teeth, presenting with either:
- Access to permanent restorative treatment in a reasonable delay (1 month) after treatment.
- Patient has a health coverage (affiliation to social security system or similar, excluding AME (Aide Médicale d'Etat)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PulpotomyConservative pulp management (experimental treatment): ablation of the coronal part of the pulp | Procedure or surgery | Pulpotomy : Conservative pulp management |
| PulpectomyAlso: root canal treatment (reference treatment)ablation of the whole dental pulp, preparation and filling of the whole root canal system | Procedure or surgery | Pulpectomy : root canal treatment |
Primary outcome
To compare the success rates of root canal treatment (pulpectomy, reference) and conservative treatment (pulpotomy)
Time frame: up to M36
Time to treatment failure, as assessed by the existence of an indication of re-intervention (with or without contra-indication).
3 secondary outcomes
To assess the impact of treatment on post-procedural pain
Time frame: D7
To describe the clinical prognostic factors of these two treatments
Time frame: baseline, M1, M6, M12, M24, M36 and time to re-treatment
To assess the additional value of biomarkers expression levels as a prognostic tool for clinical decision making (pulpectomy vs. pulpotomy).
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Individual participant dataSharing planned: No
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.
Stéphane SIMON, DDS, Mphil, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy and Pulpectomy in people with Inflammatory Pulp Diseases Related to Carious Teeth, 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 29 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 11 Nov 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane SIMON, DDS, Mphil, PhD (33142161497, stephane.simon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the success rates of root canal treatment (pulpectomy, reference) and conservative treatment (pulpotomy) (time frame: up to M36). 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 11 Nov 2016.