Prospective Endodontics Database (REone)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04716478 |
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Recruitment Status :
Recruiting
First Posted : January 20, 2021
Last Update Posted : May 6, 2021
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Endodontic treatment is necessary after certain dental trauma or in the presence of a large carious lesion, associated with signs of irreversible pulpal inflammation. The treatment of apical periodontitis is a real public health issue. The endodontic success rate is between 68 and 85%. Indeed, some studies show that systemic diseases such as diabetes can increase the prevalence and bone loss associated with apical periodontitis. Other studies identify apical periodontitis as a factor that can potentiate symptoms caused by inflammatory diseases such as cardiovascular disease and diabetes by increasing the level of inflammatory cells in the blood.
However, since 2014 the European Society of Endodontology has recommended establishing a higher level of evidence to ensure the link that these pathologies may have. For this, it is necessary to assess the criteria that may influence the healing of apical periodontitis.
Endodata has been developed by dental surgeons specializing in endodontics. The purpose of this software is to improve the clinical follow-up of patients and to establish a clinical and radiological database. In this context, the creation of a clinical database including data for all root canal treatment is of high interest.
| Condition or disease | Intervention/treatment |
|---|---|
| Apical Periodontitis | Other: Clinical and radiological data collection |
| Study Type : | Observational |
| Estimated Enrollment : | 400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Creation of a Prospective Endodontics Database |
| Actual Study Start Date : | January 22, 2021 |
| Estimated Primary Completion Date : | June 1, 2022 |
| Estimated Study Completion Date : | June 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Patient in need of endodontic care |
Other: Clinical and radiological data collection
No specific intervention. Data of the usual care will be collected as the demographic data, the medical history, imaging report, etc. |
- The main objective is to build a database with the necessary, relevant and quality data that will allow the development of a diagnostic and therapeutic aid in endodontics. [ Time Frame: follow-up at 6 months. ]The patient's medical pathologies, the results of tests and clinical examination, radiological analysis and diagnostics is recorded during routine care. The treatment protocol is detailed for each technique, product or material used.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adult patient aged ≥ 18,
- New patients received in consultation by students registered for a Diploma in Endodontics in one of the participating centres (Brest, Bordeaux, Lyon, Nancy, Nantes, Nice, Paris, Toulouse) or received by one of the private practitioners participating in the study;
- Patient with an indication for endodontic treatment or endodontic retreatment on at least one permanent tooth.
Exclusion Criteria:
- Patient unable to understand the purpose and conduct of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716478
| Contact: Brigitte GROSGOGEAT, DDS | 003362162525 | brigitte.grosgogeat@univ-lyon1.fr |
Show 21 study locations
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT04716478 |
| Other Study ID Numbers: |
69HCL20_0833 |
| First Posted: | January 20, 2021 Key Record Dates |
| Last Update Posted: | May 6, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Periodontitis Periapical Periodontitis Periodontal Diseases Mouth Diseases |
Stomatognathic Diseases Periapical Diseases Jaw Diseases |