NCT05305833

Brief Summary

It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

November 12, 2021

Last Update Submit

March 23, 2022

Conditions

Temporomandibular Joint DisordersTemporomandibular DisorderTemporomandibular Joint OsteoarthritisTemporomandibular Joint PainTemporomandibular Joint Effusion

Outcome Measures

Primary Outcomes (8)

  • Change from Baseline Pain at 15th day

    using by Visual Analogue Scale (VAS); higher scores mean worse outcome

    15th day

  • Change from baseline maximum mouth opening at 15th day

    the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly

    15th day

  • Change from baseline maximum mouth opening at 1 month

    the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at first month; higher scores means a better outcome

    1. month

  • Change from baseline maximum mouth opening at 3 months

    the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at third month; higher scores means a better outcome

    3. month

  • Change from baseline maximum mouth opening at 6 months

    the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at 6th month,higher scores means a better outcome

    6. month

  • Change from baseline pain at 1 month

    using by Visual Analogue Scale (VAS)

    1. month

  • Change from baseline pain at 3 month

    using by Visual Analogue Scale (VAS)

    3. month

  • Change from baseline pain at 6 month

    using by Visual Analogue Scale (VAS) higher scores mean worse outcome

    6. month

Secondary Outcomes (1)

  • Change from baseline 'comfort ' at 6th month

    6 months

Study Arms (2)

umbilical cord derived mesenchymal stem cells transplantation group

EXPERIMENTAL

taking umbilical cord derived mesenchymal stem cells

Biological: Stem Cells

stromal vascular fraction cells application group

EXPERIMENTAL

taking stromal vascular fraction cells

Biological: Stem Cells

Interventions

Stem CellsBIOLOGICAL

ATMP

stromal vascular fraction cells application groupumbilical cord derived mesenchymal stem cells transplantation group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic temporomandibular arthritic disorder
  • History of pain and joint noises for at least 3 months
  • Must have more than VAS 5 TMJ pain
  • must have internal derangement of TMJ
  • Limited mouth opening
  • Magnetic resonance imaging evidence of effusion or degeneration
  • Already treated with conservative methods (occlusal splint,pharmacological and/or physio-kinesio therapy) without satisfactory benefit.

You may not qualify if:

  • Cancer patients
  • Immunosupressed patients
  • Previous TMJ traumas and fractures
  • Previous TMJ surgeries
  • TMJ ankylosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Zeynep B Gonen, DDS,PHD

    Assoc.Prof

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep B Gonen, DDS,PHD

CONTACT

00903522076666zburcin@gmail.com

Genkok center

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

March 31, 2022

Study Start

October 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

TU(1)