An interventional study of Pulpotomy and Pulpectomy in Inflammatory Pulp Diseases Related to Carious Teeth, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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During the treatment, a sample of pulp tissue will be withdrawn and transferred to a molecular biology laboratory for analysis of inflammation biomarkers.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
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 :
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.
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:
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:
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:
129 studies on the registry are indexed under Dental Pulp Diseases; 39 are open to participants now.
This study's planned enrollment of 226 is above the median of 50 across 107 interventional studies indexed under Dental Pulp Diseases.
Browse Dental Pulp Diseases studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,578 studies on the registry; 1,030 are open to participants now.
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Inclusion Criteria :
Mature permanent teeth, presenting with either:
Non-inclusion criteria :
General:
Local (pertaining to the candidate tooth):
Extemporaneous exclusion criteria:
Pulpectomy : ablation of the whole dental pulp, preparation and filling of the whole root canal system
Procedure: Pulpectomy
Pulpotomy : ablation of the coronal part of the pulp
Procedure: Pulpotomy
Conservative pulp management (experimental treatment): ablation of the coronal part of the pulp
ablation of the whole dental pulp, preparation and filling of the whole root canal system
Also known as: root canal treatment (reference treatment)
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).
Time frame: up to M36
To assess the impact of treatment on post-procedural pain
Acute post-operative pain
Time frame: D7
To describe the clinical prognostic factors of these two treatments
Clinical and radiological signs such as pain, maxillary bone lesion, periodontal attachment loss, …
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
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Sep 2016, a primary completion of Sep 2019 and a completion of Sep 2020. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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