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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05305833
Other study ID # 2021/584
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 1, 2021
Est. completion date December 1, 2023

Study information

Verified date March 2022
Source TC Erciyes University
Contact Zeynep B Gonen, DDS,PHD
Phone 00903522076666
Email zburcin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Cancer patients - Immunosupressed patients - Previous TMJ traumas and fractures - Previous TMJ surgeries - TMJ ankylosis

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Stem Cells
ATMP

Locations

Country Name City State
Turkey Erciyes University Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Pain at 15th day using by Visual Analogue Scale (VAS); higher scores mean worse outcome 15th day
Primary 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
Primary 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
Primary 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
Primary 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
Primary Change from baseline pain at 1 month using by Visual Analogue Scale (VAS) 1. month
Primary Change from baseline pain at 3 month using by Visual Analogue Scale (VAS) 3. month
Primary Change from baseline pain at 6 month using by Visual Analogue Scale (VAS) higher scores mean worse outcome 6. month
Secondary Change from baseline 'comfort ' at 6th month using by Visual Analogue Scale (VAS); higher scores mean better outcome 6 months
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