Back to resultsMonocentric Study and Prognostic of Treatments Endodontics of Teeth With Periapical Pathology Realized CSERD (Nantes University Hospital)
Primary Purpose
Dental Pulp Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endodontic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients aged at least 18 years
- Patient receiving endodontic treatment for a tooth with a periapical pathology (Category IV of Baume)
- Patients affiliated to a social security scheme or of such a regime,
- Patients admitted to the CSERD,
- Patients in good general health,
- Patient compliant (see medical records: number of appointments not honored)
- Patients with a fixed address and available by telephone, pledging to return a year after treatment at a follow-up consultation for clinical and radiographic examination, and prevent CSERD of any changes of address and telephone number.
- Patients including French
- Patients free of guardianship or trusteeship
Exclusion Criteria:
- Age between 0 and 18
- Tooth with a pulp pathology type Category III of Baume
- Unspecified sheet in diagnosis
- Patients with general contraindication against the endodontic treatment of teeth with periapical pathology (risk oslérien, immuno-depressed subjects, patients with prosthetic hip, knee).
- No possibility of rubber dam during endodontic treatment.
- Patient with latex allergy (contraindicating the installation of a dam and possibly endodontic obturation with gutta-percha)
- Patients whose postoperative follow is deemed random by the investigator (cf. medical record: number of appointments not honored)
- Patient not engaging to return for clinical and radiographic examination in a year
- Patients with temporary housing or no fixed address: Living in a furnished accommodation or a hotel room, in a nursing home, in a home-type squat, Homeless
- Patients not meeting all inclusion criteria
Sites / Locations
- Nantes University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Endodontic treatment for a tooth with a periapical pathology
Arm Description
Outcomes
Primary Outcome Measures
The assessment at one year of intracanal treatment on teeth defined on clinical and radiographic criteria, as recommended by the ESE (European Society of Endodontology) (success / failure / uncertain cases)
Consider the probability of failure of intracanal treatment on teeth with periapical pathology in the first year following treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02819258
Brief Title
Monocentric Study and Prognostic of Treatments Endodontics of Teeth With Periapical Pathology Realized CSERD (Nantes University Hospital)
Official Title
Monocentric Study and Prognostic of Treatments Endodontics of Teeth With Periapical Pathology Realized CSERD (Nantes University Hospital)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Endodontic therapy is to achieve the eviction of the inflamed or infected pulp and fill the canal opening with a hermetic sealing material.
The analysis of the literature on intracanal therapeutic shows great variability of the results obtained, the reported success rate is 53 to 95%.
This is explained by the difficulty of the surgical procedure, but also by the multiplicity of possible factors of failure, related practitioner, canal anatomy, the operating procedures, the preparation techniques and root canal filling. This success rate is variable depending on the presence or absence of periapical pathology before treatment: more than 85% for teeth treated without initial periapical pathology against only 62% for teeth with pathology before treatment. Furthermore, the literature review revealed two contradictory assumptions about the dominant factor failure in endodontics: the failure of the sealing canal system (bad level shutter) against the failure of the endovascular disinfection.
Main hypothesis of the research objectives:
The probability of success in a year endodontic treatments carried out according to the recommendations and the operating standards on teeth with periapical pathology is approximately 60%.
The primary prognostic factors would be the existence of intracanal obstacles (stop calcification ...) responsible for a sub-obturation of the canal, factors inherent to the tooth (situation ductal anatomy and complexity), the operating techniques used, the practitioner ( skill level), the quality of the restoration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endodontic treatment for a tooth with a periapical pathology
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Endodontic treatment
Primary Outcome Measure Information:
Title
The assessment at one year of intracanal treatment on teeth defined on clinical and radiographic criteria, as recommended by the ESE (European Society of Endodontology) (success / failure / uncertain cases)
Description
Consider the probability of failure of intracanal treatment on teeth with periapical pathology in the first year following treatment.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged at least 18 years
Patient receiving endodontic treatment for a tooth with a periapical pathology (Category IV of Baume)
Patients affiliated to a social security scheme or of such a regime,
Patients admitted to the CSERD,
Patients in good general health,
Patient compliant (see medical records: number of appointments not honored)
Patients with a fixed address and available by telephone, pledging to return a year after treatment at a follow-up consultation for clinical and radiographic examination, and prevent CSERD of any changes of address and telephone number.
Patients including French
Patients free of guardianship or trusteeship
Exclusion Criteria:
Age between 0 and 18
Tooth with a pulp pathology type Category III of Baume
Unspecified sheet in diagnosis
Patients with general contraindication against the endodontic treatment of teeth with periapical pathology (risk oslérien, immuno-depressed subjects, patients with prosthetic hip, knee).
No possibility of rubber dam during endodontic treatment.
Patient with latex allergy (contraindicating the installation of a dam and possibly endodontic obturation with gutta-percha)
Patients whose postoperative follow is deemed random by the investigator (cf. medical record: number of appointments not honored)
Patient not engaging to return for clinical and radiographic examination in a year
Patients with temporary housing or no fixed address: Living in a furnished accommodation or a hotel room, in a nursing home, in a home-type squat, Homeless
Patients not meeting all inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedicte ENKEL, Doctor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Monocentric Study and Prognostic of Treatments Endodontics of Teeth With Periapical Pathology Realized CSERD (Nantes University Hospital)
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