Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02727088
Status:
UNKNOWN
Last Update Posted:
2016-11-11
First Post:
2016-03-07
Brief Title:
Pulpotomy vs Pulpectomy Outcome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PULPSAVE
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
Successfailure 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 andor periapicalperiradicular radiolucency PAI2 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 directindirect 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
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
Successfailure 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 andor periapicalperiradicular radiolucency PAI2 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 directindirect 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 ie 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
1 To assess the impact of treatment on post-procedural pain
2 To describe the clinical prognostic factors of these two treatments
3 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 005 1- β 08
expected rate of failure in the control group 10 year
maximal inferiority margin hazard ratio2
two years of accrual one year of follow-up
each patient is followed up to the end of study
expected loss to follow-up 10year
loss of power due to interval censorship of clinically silent failure negligible
sequential analysis Pocock scheme final test with final critical p003
Statistical analysis
Bayesian analysis analogous to a frequentist non inferiority study RRmin2 with α005 and β02
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
Primary objective and primary endpoint
To compare the success rates of root canal treatment ie 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
1 To assess the impact of treatment on post-procedural pain
2 To describe the clinical prognostic factors of these two treatments
3 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 005 1- β 08
expected rate of failure in the control group 10 year
maximal inferiority margin hazard ratio2
two years of accrual one year of follow-up
each patient is followed up to the end of study
expected loss to follow-up 10year
loss of power due to interval censorship of clinically silent failure negligible
sequential analysis Pocock scheme final test with final critical p003
Statistical analysis
Bayesian analysis analogous to a frequentist non inferiority study RRmin2 with α005 and β02
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB | OTHER | 2015-A01509-40 | None |