N/A
N=36
Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.
Periapical Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT03102879 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Number of Participats Showing Efficacy (Functionality) — 18; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Regenerative Endodontic Procedure (Procedure); Conventional Root Canal Treatment (Procedure)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Universidad de los Andes, Chile
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participats Showing Efficacy (Functionality) |
18; 18 | — |
| SECONDARY Change in Pulpal Response |
1; 1; 17; 17; 0; 1 | — |
| SECONDARY Change in Apical Lesion Size |
5; 5.5; 5.5; 7.1; 5; 5.1 | — |
| SECONDARY Pain to Percussion |
11; 5; 7; 13; 1; 0 | — |
| SECONDARY Numbers of Participants With Adverse Event |
0; 0; 0; 0 | — |
| SECONDARY Pulp Regeneration |
60.6; 74.4; 78.1 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03102879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.