Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03102879
Other study ID # RPD-8-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 23, 2016
Est. completion date September 30, 2018

Study information

Verified date January 2020
Source Universidad de los Andes, Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a controlled clinical trial designed to evaluate the survival of mature permanent teeth with apical lesion treated with regenerative endodontic procedure (REP) based on encapsulated Mesenchymal Stem Cells in a biological scaffold. The REP will be compared to the conventional endodontic therapy. The REP is based on the use of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial . The study group will use the disinfection protocol, indicated in the clinical considerations for regenerative procedures as recommended by the American Association of Endodontics, using a paste of calcium hydroxide prepared with double-distilled water as intracanal medication, and will be operated with REP using allogeneic stem cells in a scaffold, while the control group will be operated with conventional endodontic therapy alone. This clinical trial pretends to determine the dental survival of the tooth with mature apex and apical lesion, over a period of one year.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Regenerative Endodontic Procedure
Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.
Conventional Root Canal Treatment
Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.

Locations

Country Name City State
Chile Universidad de los Andes Santiago

Sponsors (2)

Lead Sponsor Collaborator
Universidad de los Andes, Chile Cells for Cells, Chile

Country where clinical trial is conducted

Chile, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT00226148 - Immediate Implant Placement in the Molar Regions Phase 0
Completed NCT05718596 - Quantitative Assessment of the Efficacy of Sweeps Laser Activation Systems N/A
Recruiting NCT00762840 - Safety and Efficacy of the Apexum Ablator N/A
Recruiting NCT05525013 - Effect of Simvastatin Versus Calcium Hydroxide Intracanal Medications on Post-operative Pain and Interleukin 6 and 8 N/A
Active, not recruiting NCT05555043 - Comparison of Clinical Outcomes Between GentleWave® and Biolase® N/A
Recruiting NCT06322979 - Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth N/A
Completed NCT02947763 - Single Versus Multiple Visits Endodontic Treatment Phase 1
Completed NCT05857436 - Relationship Apical Periodontitis and the Main Bacterial Species in the Oral Microbiota N/A
Active, not recruiting NCT03660163 - Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography.
Completed NCT02801552 - Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF N/A
Completed NCT02632513 - Effect of Passive Ultrasonic Irrigation on Success of Primary Endodontic Treatment N/A
Completed NCT01312194 - Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients N/A
Completed NCT00223327 - Measurement of Bite Force in Humans Phase 0
Completed NCT05297747 - Adrenomedullin Upregulation in Apical Periodontitis N/A
Completed NCT03708081 - Comparative Evaluation of Different File Systems in Postoperative Pain
Recruiting NCT01799187 - Research of Revascularization in Immature Teeth With Periapical Periodontitis N/A
Completed NCT06023901 - The Importance of Prostaglandin and Nitric Oxide Synthesis in Apical Periodontitis N/A
Completed NCT02747082 - Antibacterial Effectiveness of Two Root Canal Irrigants Phase 2
Completed NCT06339905 - The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success N/A
Completed NCT05719987 - Biodentine as an Apical Plug in Immature Permanent Molars N/A