Temporomandibular Joint DisordersNCT04936945

Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases

A study testing Temporomandibular joint arthroscopy plus intra-articular injection in people with Temporomandibular Joint Disorders, run by Sohag University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to evaluate the efficacy of intra-articular injection of platelet rich plasma versus hyaluronic acid following diagnostic arthroscopy in the management of patients suffering from degenerative temporomandibular joint (TMJ). Read more about this study

Who is it for?: Ages 5 years and older
Conditions the study is for: Temporomandibular Joint Disorders
What is being tested?: Temporomandibular joint arthroscopy plus intra-articular injection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteEgypt
Study dates: 13 Jun 2021to 16 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

- All patients with reduced mouth opening and/or painful maximum mouth opening.
Joint pain.
Patients with radiological evidence of degenerative joint disease.
Patients with unsuccessful medical conservative treatment for at least two months.
Unilateral or bilateral temporomandibular joint involvement.
Wilkes stages IV and V

Who cannot join

- Patients with bony ankylosis .
Patients with advanced resorption of the glenoid fossa.
Patients with infection or tumors around joint area
Patients unfit for intervention medically.
Patients who refused to share in the study

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Sohag University
Sohag, 82525

Other trials in Egypt

About this study

Official title: Comparative Study Between the Outcome of Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Arthroscopic Management of Temporomandibular Degenerative Joint Diseases: A Randomized Clinical Trial

This is a prospective randomized study of 20 patients with TMJ degenerative joint diseases Wilkes IV, V.

Patients will be divided into two groups; Group A: will be treated with operative arthroscopy plus intra-articular platelet rich plasma.

Group B: will be treated with operative arthroscopy plus intra-articular hyaluronic acid.

Conditions: Temporomandibular Joint Disorders
Being tested: Temporomandibular joint arthroscopy plus intra-articular injection
Medical subject headings: Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Temporomandibular joint arthroscopy plus intra-articular injectionProcedure or surgery
patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma or hyaluronic acid will be done.

Study groups in NCT04936945
Study group	Role	What they receive
arthroscopy plus platelet rich plasma.	Active comparator	Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma Receives: Procedure: Temporomandibular joint arthroscopy plus intra-articular injection
arthroscopy plus hyaluronic acid.	Active comparator	Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid Receives: Procedure: Temporomandibular joint arthroscopy plus intra-articular injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Interincisal Opening (MIO) Measurements
change in maximum inter-incisal mouth opening will be measured in millimeters between preoperative and postoperative at 1 week,3 weeks, the every month till 6 months
Measured: change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative
Pain Intensity Measurements
A 100 -point visual analogue scale (VAS) for the assessment of pain intensity with 0 as the absence of pain and 100 as the worst pain imaginable With filled standardized charts.
Measured: change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 202116 May 2023

First posted23 Jun 2021
Study start13 Jun 2021
Primary completion12 May 2023
Study completion16 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
More trials run by Sohag UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04936945
Sponsor's protocol ID: Soh-Med-21-06-15
Status last verified: Apr 2024
First submitted: 13 Jun 2021
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

All Temporomandibular Joint Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study Between the Outcome of Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Arthroscopic Management of Temporomandibular Degenerative Joint Diseases: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04936945
Acronym / sponsor ID: Soh-Med-21-06-15
Conditions: Temporomandibular Joint Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Sohag UniversityUniversity, hospital or other
Study start: 13 Jun 2021 (actual)
Primary completion: 12 May 2023 (actual)
Study completion: 16 May 2023 (actual)
First posted: 23 Jun 2021 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a prospective randomized study of 20 patients with TMJ degenerative joint diseases Wilkes IV, V.

Patients will be divided into two groups; Group A: will be treated with operative arthroscopy plus intra-articular platelet rich plasma.

Group B: will be treated with operative arthroscopy plus intra-articular hyaluronic acid.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
arthroscopy plus platelet rich plasma.	Active comparator	Procedure: Temporomandibular joint arthroscopy plus intra-articular injectionGroup A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma
arthroscopy plus hyaluronic acid.	Active comparator	Procedure: Temporomandibular joint arthroscopy plus intra-articular injectionGroup B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid

Who may qualify

Ages: 5 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

- All patients with reduced mouth opening and/or painful maximum mouth opening.
Joint pain.
Patients with radiological evidence of degenerative joint disease.
Patients with unsuccessful medical conservative treatment for at least two months.
Unilateral or bilateral temporomandibular joint involvement.

Key exclusion criteria (5 listed)

- Patients with bony ankylosis .
Patients with advanced resorption of the glenoid fossa.
Patients with infection or tumors around joint area
Patients unfit for intervention medically.
Patients who refused to share in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Temporomandibular joint arthroscopy plus intra-articular injectionpatients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma or hyaluronic acid will be done.	Procedure or surgery	arthroscopy plus hyaluronic acid., arthroscopy plus platelet rich plasma.

Primary outcome

Maximum Interincisal Opening (MIO) Measurements
Time frame: change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative
change in maximum inter-incisal mouth opening will be measured in millimeters between preoperative and postoperative at 1 week,3 weeks, the every month till 6 months
Pain Intensity Measurements
Time frame: change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative
A 100 -point visual analogue scale (VAS) for the assessment of pain intensity with 0 as the absence of pain and 100 as the worst pain imaginable With filled standardized charts.

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arthroscopy Plus Platelet Rich Plasma.	10	10
Arthroscopy Plus Hyaluronic Acid.	10	10

Primary outcome: Maximum Interincisal Opening (MIO) Measurements

Time frame: change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative. Mean (Standard Deviation). Unit: Millimeter

Measure	Arthroscopy Plus Platelet Rich Plasma. n = 10	Arthroscopy Plus Hyaluronic Acid. n = 10
Pre-operative	23.1 (6.71)	27.9 (4.51)
1-week PO	33.8 (3.43)	35.6 (3.96)
3-weeks PO	36 (4.4)	36.7 (4.92)
1-month PO	36.7 (5.08)	37.3 (5.5)
2-months PO	36.7 (5.08)	37.6 (5.21)
3-months PO	37.6 (4.55)	38.2 (4.71)
4-months PO	37.1 (4.41)	38 (4.29)
5-months PO	36.8 (4.78)	38.3 (4.06)

Primary outcome: Pain Intensity Measurements

Time frame: change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative. Mean (Standard Deviation). Unit: score on a scale

Measure	Arthroscopy Plus Platelet Rich Plasma. n = 10	Arthroscopy Plus Hyaluronic Acid. n = 10
preoperative	49 (20.79)	49 (21.32)
1-week PO	28 (14.76)	30 (14.14)
3-weeks PO	21 (8.76)	25 (14.34)
1-month PO	16 (9.66)	20 (14.91)
2-months PO	13 (6.75)	13 (9.49)
3-months PO	12 (7.89)	7 (4.83)
4-months PO	12 (10.33)	4 (5.16)
5-months PO	14 (13.5)	3 (4.83)

Adverse events

Time frame: 23 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arthroscopy Plus Platelet Rich Plasma.	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Arthroscopy Plus Hyaluronic Acid.	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Temporomandibular Joint Disorders

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samia M Saied, MD study chair

Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Temporomandibular joint arthroscopy plus intra-articular injection in people with Temporomandibular Joint Disorders, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Interincisal Opening (MIO) Measurements (time frame: change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04936945.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.