Dental Pulp Regeneration by Autologous Tissue Transplantation
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|ClinicalTrials.gov Identifier: NCT03833401|
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dental Pulp Regeneration||Procedure: Autologous tissue transplantation Procedure: Root canal revascularization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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.|
|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|
Sham Comparator: Root canal revascularization
Root canal disinfection and revascularization without tissue transplantation. This will serve as control group.
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.
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.
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,PhDemail@example.com|
|Contact: Yangpei Cao, DDS, MSfirstname.lastname@example.org|
|United States, California|
|UCLA School of Dentistry||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Lisa Gotori-Koga 310-825-7141 email@example.com|
|Sub-Investigator: Yangpei Cao, DDS,MS|
|Principal Investigator:||Mo Kang, DDS,PhD||University of California, Los Angeles|