Dental Pulp Regeneration by Autologous Tissue Transplantation
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ClinicalTrials.gov Identifier: NCT03833401 |
Recruitment Status : Unknown
Verified February 2019 by Mo K. Kang, DDS, PhD, University of California, Los Angeles.
Recruitment status was: Recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
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Condition or disease | Intervention/treatment | Phase |
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Dental Pulp Regeneration | Procedure: Autologous tissue transplantation Procedure: Root canal revascularization | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This study will involve two Arms; one serving as sham comparator, and the other arm serving as experimental (test) group. |
Masking: | Single (Participant) |
Masking Description: | Randomized |
Primary Purpose: | Treatment |
Official Title: | Dental Pulp Regeneration for Root Canals by Autologous Tissue Transplantation |
Estimated Study Start Date : | February 1, 2019 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | June 30, 2021 |
Arm | Intervention/treatment |
---|---|
Sham Comparator: Root canal revascularization
Root canal disinfection and revascularization without tissue transplantation. This will serve as control group.
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Procedure: Root canal revascularization
Root canal disinfection and revascularization without tissue transplantation |
Experimental: Autologous tissue transplantation
Root canal disinfection will be performed and revascularization will be induced with autologous tissue transplantation.
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Procedure: Autologous tissue transplantation
Root canal disinfection and revascularization with patient's own minced pulp tissues |
- Changes in radiographic assessment for periapical inflammation [ Time Frame: 6 months, 12 months, and 24 months ]This outcome will test the effect of treatment in either Arm on resolving periapical inflammation, which will be assessed by radiographic imaging and clinical examination. Healing of periapical inflammatory lesion will be measured by radiographic imaging to note changes in the size of pre-existing radiograph periapical lesions after the treatment.
- Changes in pulpal sensibility to temperature and electric current [ Time Frame: 6 months, 12 months, and 24 months ]This outcome will test whether the treatment in either Arm will allow revitalization of pulp tissues, by means of thermal and electrical testing of pulp vitality.
- Changes in root dentin thickness of root canals [ Time Frame: 6 months, 12 months, and 24 months ]This outcome will assess changes in root dentin thickness after treatment in either arm. We will also determine if the apical opening (foramen) will close in cases that initially present with open apices. This assessment will be based on radiographic imaging.
- Changes in root length [ Time Frame: 6 months, 12 months, and 24 months ]This outcome will assess changes in root length after treatment in either arm. This assessment will be based on radiographic imaging.
- Changes of root canal calcification in teeth treated by revascularization with or without tissue transplantation [ Time Frame: 6 months, 12 months, and 24 months ]This outcome will assess the degree of root canal calcification in teeth treated in either Arm by radiographic imaging. Degree of calcification will be measured by means of different levels of radio-opacity in routine dental X rays.
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Ages Eligible for Study: | 7 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male or female participants at ages of 7 - 50 y.o. presenting with a tooth diagnosed with complete or partial necrosis of the pulp or irreversible pulpitis.
- Participants presenting with donor pulp tissue, either from existing deciduous teeth or from permanent teeth treatment planned for extraction, e.g., second premolars for orthodontic extraction or third molars.
- Participants presenting with irreversible pulpitis and partial necrosis, i.e., visible pulpal tissues during access opening and canal debridement.
- Participants with immature root apices, including those with partially closed apex, that require root canal procedure.
Exclusion Criteria:
- Participants with any systemic conditions preventing routine dental procedures or requiring medication that interfere with healing or induce bleeding.
- Participants with avulsed, replanted teeth with resultant pulp necrosis.
- Participants with vertical root fracture/cracks.
- Participants with teeth that are not restorable.
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): NCT03833401
Contact: Mo Kang, DDS,PhD | 310-825-8048 | mkang@dentistry.ucla.edu | |
Contact: Yangpei Cao, DDS, MS | 310-825-7165 | ycao@dentistry.ucla.edu |
United States, California | |
UCLA School of Dentistry | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Lisa Gotori-Koga 310-825-7141 lgotori@dentistry.ucla.edu | |
Sub-Investigator: Yangpei Cao, DDS,MS |
Principal Investigator: | Mo Kang, DDS,PhD | University of California, Los Angeles |
Responsible Party: | Mo K. Kang, DDS, PhD, Professor, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT03833401 |
Other Study ID Numbers: |
18-000077 |
First Posted: | February 7, 2019 Key Record Dates |
Last Update Posted: | February 7, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |