Pulpotomy vs Pulpectomy Outcome.

NCT02727088 | Unknown

• 2 other identifiers: P140941IDRCB
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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. 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 During the treatment, a sample of pulp tissue will be withdrawn and transferred to a molecular biology laboratory for analysis of inflammation biomarkers.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.

Conditions

Inflammatory Pulp Diseases Related to Carious Teeth

Keywords

Dental Pulp Disease; Endodontics; Pulp Capping; Pulpotomy; Pulpectomy

Outcome Measures

Primary Outcomes (1)

• 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).

  up to M36

Secondary Outcomes (3)

• To assess the impact of treatment on post-procedural pain

  D7

• To describe the clinical prognostic factors of these two treatments

  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).

  baseline

Study Arms (2)

Pulpectomy : root canal treatment

ACTIVE COMPARATOR

Pulpectomy : ablation of the whole dental pulp, preparation and filling of the whole root canal system

Procedure: Pulpectomy

Pulpotomy : Conservative pulp management

EXPERIMENTAL

Pulpotomy : ablation of the coronal part of the pulp

Procedure: Pulpotomy

Interventions

Pulpotomy PROCEDURE

Conservative pulp management (experimental treatment): ablation of the coronal part of the pulp

Pulpotomy : Conservative pulp management

Pulpectomy PROCEDURE

ablation of the whole dental pulp, preparation and filling of the whole root canal system

Also known as: root canal treatment (reference treatment)

Pulpectomy : root canal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Rennes University Hospital: collaborator
• Nantes University Hospital: collaborator
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (1)

Hôpital Pitié Salpêtriere

Paris, 75651, France

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Pulpotomy; Pulpectomy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Stéphane SIMON, DDS, Mphil, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane SIMON, DDS, Mphil, PhD

CONTACT

33142161497; stephane.simon@aphp.fr

Marjorie ZANINI, DDS

CONTACT

33142161014; marjoriezanini@hotmail.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: April 4, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: November 11, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)