Dental Pulp Regeneration by Autologous Tissue Transplantation

NCT03833401 | Unknown DMC

• 1 other identifier: 18-000077
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pulp Regeneration

Outcome Measures

Primary Outcomes (5)

• Changes in radiographic assessment for periapical inflammation

  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.

  6 months, 12 months, and 24 months

• Changes in pulpal sensibility to temperature and electric current

  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.

  6 months, 12 months, and 24 months

• Changes in root dentin thickness of root canals

  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.

  6 months, 12 months, and 24 months

• Changes in root length

  This outcome will assess changes in root length after treatment in either arm. This assessment will be based on radiographic imaging.

  6 months, 12 months, and 24 months

• Changes of root canal calcification in teeth treated by revascularization with or without tissue transplantation

  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.

  6 months, 12 months, and 24 months

Study Arms (2)

Root canal revascularization

SHAM COMPARATOR

Root canal disinfection and revascularization without tissue transplantation. This will serve as control group.

Procedure: Root canal revascularization

Autologous tissue transplantation

EXPERIMENTAL

Root canal disinfection will be performed and revascularization will be induced with autologous tissue transplantation.

Procedure: Autologous tissue transplantation

Interventions

Autologous tissue transplantation PROCEDURE

Root canal disinfection and revascularization with patient's own minced pulp tissues

Autologous tissue transplantation

Root canal revascularization PROCEDURE

Root canal disinfection and revascularization without tissue transplantation

Root canal revascularization

Eligibility Criteria

• Age: 7 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA School of Dentistry

Los Angeles, California, 90095, United States

RECRUITING

Study Officials

• Mo Kang, DDS,PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mo Kang, DDS,PhD

CONTACT

310-825-8048; mkang@dentistry.ucla.edu

Yangpei Cao, DDS, MS

CONTACT

310-825-7165; ycao@dentistry.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will involve two Arms; one serving as sham comparator, and the other arm serving as experimental (test) group.

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: February 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)