Periapical Diseases Clinical Trial
— CARETTOfficial title:
Cell-free Autologous Regenerative Endodontics Treatment for Permanent Mature Teeth With Pulp Necrosis and Periapical Lesions: a Randomized, Controlled Phase III Clinical Trial (CARETT)
NCT number | NCT05305417 |
Other study ID # | 211 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2023 |
Est. completion date | March 2025 |
Conventional endodontic treatment has been the treatment of choice for the management of signs and symptoms of mature permanent teeth with pulpal necrosis and periapical lesion with predictable and favorable results. However, treatment outcomes have not shown improvement or innovation in decades. The main objective of this study is to evaluate the clinical effectiveness of a regenerative endodontic procedure (cell-free and autologous protocol) versus conventional endodontics in the resolution of signs and symptoms of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with a diagnosis of pulpal necrosis and periapical lesion.
Status | Not yet recruiting |
Enrollment | 228 |
Est. completion date | March 2025 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Male or female (18-60y) systemically healthy or chronic disease controlled - Uniradicular or multiradicular permanent mature teeth - Teeth with diagnosis of pulp necrosis (negative response to thermal-cold pulp test) and sings or symptoms (clinical-radiographic) of periapical lesion. - Root anatomy with curvatures = 30° - Feasibility of adhesive tooth restoration (direct or indirect) - Voluntary participation under informed consent Exclusion Criteria: - Pregnant or lactating woman - Signs of moderate or severe periodontal disease - Teeth with signs of radicular fracture (vertical or horizontal), signs of root resorption (endo-exo) - teeth with impossibility of good prognosis of coronary rehabilitation by direct or indirect adhesive technique - Teeth that to treat can not to be correctly isolate with rubber dam |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Universidad de Valparaiso |
About I. Proceedings of the Pulp Biology and Regeneration Group Symposium 2019: Bridging Basic and Translational Research in Pulp Biology-Developing Technologies for Regenerating Vital Dental Tissues. J Endod. 2020 Sep;46(9S):S1. doi: 10.1016/j.joen.2020.06.018. — View Citation
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of therapy | Number of treated tooth that remain in mouth free of clinical (negative percussion, negative palpation, abscence of inflammation, pain and fistula) and radiographic (total or partial reduction on size of periapical lesion) signs or symptoms at 12 month post operatory. | 12 month | |
Secondary | Tooth re-sensibilization | Number of treated tooth that response positively to thermal pulp sensibility test (cold stimulus) after 3, 6 and 12 months post operatory in relation with the initial negative pulp test. The positive-negative pulp sensibility response of treated teeth first is standardized testing the homologous vital tooth on the mouth. | 3, 6 and 12 month | |
Secondary | Tooth re-vitalization | Number of treated tooth that response positively to Vitality Pulp Test Doppler laser flowmetry after 3, 6 and 12 month. This Vitality Test assess pulpal blood flow by the detection of light scatter generated by moving erythrocytes. The positive-negative pulp vitality response of the treated teeth first is standardized testing the homologous vital tooth on the mouth. | 3, 6 and 12 month | |
Secondary | Periapical lesion resolution | Resolution of an periapical lesion using Periapical Index (PI), a scoring system for registration of apical periodontitis in radiographs | 3, 6 and 12 month | |
Secondary | Procedure Time | total time required to perform each of the therapies recorded in minutes | intraoperatory |
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