Periapical Periodontitis Clinical Trial
— RanoKureOfficial title:
Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.
Verified date | January 2020 |
Source | Universidad de los Andes, Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the dental survival in a period of one year of mature permanent teeth with apical lesion following the administration of encapsulated Mesenchymal Stem Cells under a regenerative endodontic procedure and a conventional root canal treatment.
Status | Completed |
Enrollment | 36 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 58 Years |
Eligibility |
Inclusion Criteria: Patient inclusion criteria: - Age: 16 - 58 years old. - Signed the informed consent. - Non-smoking. - Systemically healthy patients Tooth inclusion criteria: - Upper and lower incisors, upper and lower canines and lower premolars teeth with mature apex and apical lesion (greater than 2 PAI and 1 CBCTPAI). - Teeth that do not response to both electrical and thermal pulp test - Teeth that can be restored (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown. Exclusion Criteria: Patient exclusion criteria: - Patients without a phone number for contact during the study. - Subjects not available for follow up period (12 months). - Patients who are or will undergo orthodontic treatment over the next 12 months. - Patients with an allergy to any material or drug used in the study. - Patients who are pregnant or lactating. - Patients with a history of systemic diseases that alter immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's disease and Cushing. - Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study. Tooth exclusion criteria: - Endodontically treated teeth - Teeth with signs of severe root resorption. - Teeth with mobility class III or Dens invaginatus. - Teeth with avulsion history and conservation in a dry extraoral medium for more than 1 hour. - Teeth with clinical and / or radiographic evidence of root fracture. - Teeth that can not be absolutely isolated with rubber dam. . Teeth with more than one root or root canal. |
Country | Name | City | State |
---|---|---|---|
Chile | Universidad de los Andes | Santiago |
Lead Sponsor | Collaborator |
---|---|
Universidad de los Andes, Chile | Cells for Cells, Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participats Showing Efficacy (Functionality) | Efficacy (functionality) was defined when one year after the intervention, the treated tooth remains in the mouth, without pain to percussion test and with apical bone lesion of equal size in the three senses of space or a decrease in some of them or no more than 0.1 mm increase of one of them. | 12 months | |
Secondary | Change in Pulpal Response | Change in pulpal response (period 1 year) will be assessed through response to sensitivity tests (cold, hot and electrical test) in teeth treated with regenerative procedure and conventional endodontic treatment during time. | baseline, 6 months, 12 months | |
Secondary | Change in Apical Lesion Size | Change in apical lesion size will be evaluated by cone beam tomography 6 and 12 months after intervention is completed. | baseline, 6 months, 12 months | |
Secondary | Pain to Percussion | To compare pain to percussion in a period of 1 year in permanent teeth with mature apex and apical lesion, treated with a regenerative endodontic procedure and conventional endodontic therapy. This will be monitored 6 and 12 months after the procedure is completed. Pain to percussion positive: The tooth is tenderness when is softly tapped with handle end of a dental mirror at examination time. Pain to percussion negative: The tooth is not tenderness when is softly tapped with handle end of a dental mirror at examination time. |
baseline, 6 months, 12 months | |
Secondary | Numbers of Participants With Adverse Event | To describe adverse events in a period of 1 year in permanent teeth with mature apex and apical lesion, operated with a regenerative endodontic procedure and conventional endodontic therapy. | 6 months, 12 months | |
Secondary | Pulp Regeneration | To describe the pulp regeneration by means of vitality test using Doppler laser flowmetry (LDF) in a period of 1 year in permanent teeth with mature apex and apical lesion treated with a regenerative endodontic procedure. The vitality of the teeth was measured by LDF and the perfusion units (PU) percentage of the tooth under study was determined with respect to a healthy control tooth with similar anatomical characteristics from the same patient. |
baseline, 6 months, 12 months |
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