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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
Sponsor:
Information provided by (Responsible Party):
Mo K. Kang, DDS, PhD, University of California, Los Angeles

Brief Summary:
The purpose of this study is to develop new improved therapy for teeth that require root canals due to tooth infection or tooth inflammation. Investigators will recruit total of 50 participants from the age group 7 - 50 at the UCLA School of Dentistry Endodontic clinic. The participants will be divided into two groups, one will receive traditional therapy, which may include root canal or a procedure called "revascularization," which is a procedure trying to regrow the tissue inside the tooth. The other group of participants will receive the test treatment, which will involve harvesting of pulp tissues from the same tooth or other teeth that are planned for extraction. Investigators will prepare these tissues and place the tissues back into the cleaned root canal space with induced bleeding to allow regrowth of the tissue. For all participants, investigators will follow up after 6, 12, and 24 months in a shorter appointment, which may involve taking x-ray and clinical exam.

Condition or disease Intervention/treatment Phase
Dental Pulp Regeneration Procedure: Autologous tissue transplantation Procedure: Root canal revascularization Not Applicable

Detailed Description:
The goal of the study is to test whether autologous pulpal mesenchymal stem cells (MSCs) is capable of de novo regeneration of pulp-dentin complex and restoration of normal pulp physiology in teeth with necrotic or inflamed pulp. This is a highly novel study that will bring the regenerative endodontic approaches to the next level. Furthermore, revascularization approaches, as delivered in today's endodontic offices, present several challenges, including lack of de novo pulp-dentin regeneration, and frequent occurrence of intracanal calcification. These findings attest to the limitation of revascularization as a regenerative endodontic procedure (REP) and necessitates advent of novel approach for functional restoration of dental pulp. The ultimate objective of the current study is to develop a new REP that allows for de novo regeneration of functional dental pulp, which can be readily performed in a chair-side manner.

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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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mo Kang, DDS,PhD 310-825-8048 mkang@dentistry.ucla.edu
Contact: Yangpei Cao, DDS, MS 310-825-7165 ycao@dentistry.ucla.edu

Locations
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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         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Mo Kang, DDS,PhD University of California, Los Angeles

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Responsible Party: Mo K. Kang, DDS, PhD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03833401     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No