TMJ PainNCT06345092
Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain
A study testing Vitamin C and Injectable platelet rich fibrin in people with TMJ Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- TMJ Pain
- What is being tested?
- Vitamin C and Injectable platelet rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with internal TMJ derangement (anterior disc displacement with reduction)
Who cannot join
- Pathological conditions ; trauma TMJ cases or any blood diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Injectable Platelet Rich Fibrin With Vitamin C and Injectable Platelet Rich Fibrin Alone in Management of ID'Pain
Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement
Read the detailed description
Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement
- Conditions
- TMJ Pain
- Being tested
- Vitamin C, Injectable platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called Ascorbic acid
addition of vitamin C to IPRF
Injectable platelet rich fibrinOther
Also called IPRF
injection of IPRF alone
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | injection of injectable platelet rich fibrin with vitamin C Receives: Drug: Vitamin C; Other: Injectable platelet rich fibrin |
| control group | Active comparator | injection of injectable platelet rich fibrin alone Receives: Other: Injectable platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain management
Evaluation of pain using VAS pre and post injections
Measured: at 4;8;12;16 weeks
Secondary outcomes (1)
disc position using MRI
evaluation of disc position pre and post injections
Measured: at 4;8;12;16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start15 Apr 2024
- Primary completion15 May 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ PainStudies of the same condition, open and under way.
- More trials run by Cairo 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, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youmna alaa yehia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345092
- Sponsor's protocol ID
- Omfs.3-3-3
- Status last verified
- Nov 2024
- First submitted
- 26 Mar 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Injectable Platelet Rich Fibrin With Vitamin C and Injectable Platelet Rich Fibrin Alone in Management of ID'Pain
- ClinicalTrials.gov ID
- NCT06345092
- Acronym / sponsor ID
- Omfs.3-3-3
- Conditions
- TMJ Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement
Detailed description
Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Vitamin C, Other: Injectable platelet rich fibrininjection of injectable platelet rich fibrin with vitamin C |
| control group | Active comparator | Other: Injectable platelet rich fibrininjection of injectable platelet rich fibrin alone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with internal TMJ derangement (anterior disc displacement with reduction)
Key exclusion criteria (1 listed)
- Pathological conditions ; trauma TMJ cases or any blood diseases
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 |
|---|---|---|
| Vitamin CAlso: Ascorbic acidaddition of vitamin C to IPRF | Drug | intervention group |
| Injectable platelet rich fibrinAlso: IPRFinjection of IPRF alone | Other | control group, intervention group |
Primary outcome
Pain management
Time frame: at 4;8;12;16 weeks
Evaluation of pain using VAS pre and post injections
1 secondary outcome
disc position using MRI
Time frame: at 4;8;12;16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C and Injectable platelet rich fibrin in people with TMJ Pain, run by Cairo 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 1 inclusion and 1 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 8 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain management (time frame: at 4;8;12;16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.