TMDPhase 2NCT07798258
Assessment of Injectable PRF Versus Dextrose Injection in Temporomandibular Joint in Anterior Disc Displacement With Reduction
A Phase 2 study testing PRF treatment group and Dextrose 20% Prolotherapy in people with TMD, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to compare the accuracy and effectiveness of injectable platelet-rich fibrin (I-PRF) versus 25% dextrose prolotherapy injected into retrocondylar tissues in patients with anterior disc displacement with reduction of the temporomandibular joint. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TMD
- What is being tested?
- PRF treatment group and Dextrose 20% Prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 10 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Age ≥18 years. Female patients. Patients with anterior disc displacement with reduction. Anterior disc displacement with reduction assessed using preoperative MRI in open- and closed-mouth positions.
- Patients who are willing and fully capable of complying with the study protocol.
Who cannot join
- Participants will be excluded if they have:
- Bleeding disorders or are receiving anticoagulant medications. Pregnancy. Bony pathology of the temporomandibular joint. Temporomandibular disorder patients or patients with anterior disc displacement without reduction.
- Any temporomandibular joint infection. Mental instabilities or psychiatric conditions. Previous invasive or surgical procedures of the temporomandibular joint. Inability to attend follow-up during the entire follow-up period. Refusal to sign the written informed consent. Dystonia.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized clinical trial aims to compare the accuracy and effectiveness of injectable platelet-rich fibrin (I-PRF) versus 25% dextrose prolotherapy injected into retrocondylar tissues in patients with anterior disc displacement with reduction of the temporomandibular joint. The study will evaluate improvement in disc position, pain, mouth opening, and clicking sounds following treatment.
Read the detailed description
Anterior disc displacement with reduction is a common intra-articular disorder of the temporomandibular joint and may be associated with clicking sounds, pain, and impaired mandibular function. This randomized clinical trial will compare injectable platelet-rich fibrin (I-PRF) with 25% dextrose injection in retrocondylar tissues in patients with anterior disc displacement with reduction.
Participants will be randomly allocated into two parallel groups with an allocation ratio of 1:1. The intervention group will receive 1.5 cc of I-PRF injected into the retrocondylar tissues at 0, 2, and 4 weeks. The control group will receive 1.5 mL of 25% dextrose solution injected into the retrocondylar tissues at 0, 2, and 4 weeks.
Clinical outcomes will include pain intensity assessed using a Visual Analogue Scale, maximum mouth opening measured using a digital caliper, and the presence or absence of clicking sounds. Magnetic resonance imaging will be performed before treatment and at 6 months after treatment to evaluate the position of the articular disc in open- and closed-mouth positions.
Clinical assessments will be performed preoperatively and at 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.
- Conditions
- TMD
- Being tested
- PRF treatment group, Dextrose 20% Prolotherapy
- Keywords
- Disc Displacement with reduction, Dextrose in retrodiscal tissue, injectable PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF treatment groupDrug
Participants in the I-PRF group will receive 1.5 cc of injectable platelet-rich fibrin (I-PRF) injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. Approximately 10 mL of blood will be withdrawn from the patient's antecubital fossa using vacuum tubes and centrifuged at 700 RPM for 3 minutes for I-PRF preparation. The resulting I-PRF will be transferred using a sterile 22-gauge 3 mL plastic syringe and injected into the retrocondylar tissues. In cases of bilateral involvement, the procedure will be repeated on the opposite side.
Dextrose 20% ProlotherapyDrug
Participants in the control group will receive 1.5 mL of 25% hypertonic dextrose solution injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. The solution will be mixed with 0.2 mL of local anaesthetic solution containing 2% mepivacaine hydrochloride with 1:20,000 levonordefrin. The substances will be injected under aseptic conditions using a 22-gauge needle. In cases of bilateral involvement, the procedure will be repeated on the opposite side.
| Study group | Role | What they receive |
|---|---|---|
| I-PRF Group | Experimental | Participants in the I-PRF group will receive 1.5 cc of injectable platelet-rich fibrin (I-PRF) injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. Approximately 10 mL of blood will be withdrawn from the patient's antecubital fossa using vacuum tubes and centrifuged at 700 RPM for 3 minutes for I-PRF preparation. The resulting I-PRF will be transferred using a sterile 22-gauge 3 mL plastic syringe and injected into the retrocondylar tissues. In cases of bilateral involvement, the procedure will be repeated on the opposite side. Receives: Drug: PRF treatment group |
| Dextrose 25% Group | Active comparator | Participants in the control group will receive 1.5 mL of 25% hypertonic dextrose solution injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. The solution will be mixed with 0.2 mL of local anaesthetic solution containing 2% mepivacaine hydrochloride with 1:20,000 levonordefrin. The substances will be injected under aseptic conditions using a 22-gauge needle. In cases of bilateral involvement, the procedure will be repeated on the opposite side. Receives: Drug: Dextrose 20% Prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the Position of the Articular Disc
Improvement in the position of the articular disc will be assessed by comparing preoperative and postoperative MRI measurements of disc position in both closed- and open-mouth positions.
Measured: 6 months
Secondary outcomes (3)
Pain Intensity
Pain intensity will be assessed using a Visual Analogue Scale (VAS), with 0 representing no or absent pain and 10 representing the worst or unbearable pain.
Measured: Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.
Maximum Mouth Opening (MMO)
Maximum mouth opening will be measured in millimeters from the incisal edge of the upper right central incisor to the lower right central incisor in the maximum mouth-open position using a digital caliper.
Measured: Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.
Temporomandibular Joint Clicking
The presence or absence of clicking sounds of the temporomandibular joint will be recorded.
Measured: Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start10 Oct 2025
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Nasr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798258
- Sponsor's protocol ID
- Oms3-3-3
- Status last verified
- Oct 2025
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Injectable PRF Versus Dextrose Injection in Temporomandibular Joint in Anterior Disc Displacement With Reduction
- ClinicalTrials.gov ID
- NCT07798258
- Acronym / sponsor ID
- Oms3-3-3
- Conditions
- TMD
- Keywords
- Disc Displacement with reduction, Dextrose in retrodiscal tissue, injectable PRF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 1 Sep 2026 (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.
This randomized clinical trial aims to compare the accuracy and effectiveness of injectable platelet-rich fibrin (I-PRF) versus 25% dextrose prolotherapy injected into retrocondylar tissues in patients with anterior disc displacement with reduction of the temporomandibular joint. The study will evaluate improvement in disc position, pain, mouth opening, and clicking sounds following treatment.
Detailed description
Anterior disc displacement with reduction is a common intra-articular disorder of the temporomandibular joint and may be associated with clicking sounds, pain, and impaired mandibular function. This randomized clinical trial will compare injectable platelet-rich fibrin (I-PRF) with 25% dextrose injection in retrocondylar tissues in patients with anterior disc displacement with reduction.
Participants will be randomly allocated into two parallel groups with an allocation ratio of 1:1. The intervention group will receive 1.5 cc of I-PRF injected into the retrocondylar tissues at 0, 2, and 4 weeks. The control group will receive 1.5 mL of 25% dextrose solution injected into the retrocondylar tissues at 0, 2, and 4 weeks.
Clinical outcomes will include pain intensity assessed using a Visual Analogue Scale, maximum mouth opening measured using a digital caliper, and the presence or absence of clicking sounds. Magnetic resonance imaging will be performed before treatment and at 6 months after treatment to evaluate the position of the articular disc in open- and closed-mouth positions.
Clinical assessments will be performed preoperatively and at 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-PRF Group | Experimental | Drug: PRF treatment groupParticipants in the I-PRF group will receive 1.5 cc of injectable platelet-rich fibrin (I-PRF) injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. Approximately 10 mL of blood will be withdrawn from the patient's antecubital fossa using vacuum tubes and centrifuged at 700 RPM for 3 minutes for I-PRF preparation. The resulting I-PRF will be transferred using a sterile 22-gauge 3 mL plastic syringe and injected into the retrocondylar tissues. In cases of bilateral involvement, the procedure will be repeated on the opposite side. |
| Dextrose 25% Group | Active comparator | Drug: Dextrose 20% ProlotherapyParticipants in the control group will receive 1.5 mL of 25% hypertonic dextrose solution injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. The solution will be mixed with 0.2 mL of local anaesthetic solution containing 2% mepivacaine hydrochloride with 1:20,000 levonordefrin. The substances will be injected under aseptic conditions using a 22-gauge needle. In cases of bilateral involvement, the procedure will be repeated on the opposite side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must meet all of the following criteria:
- Age ≥18 years. Female patients. Patients with anterior disc displacement with reduction. Anterior disc displacement with reduction assessed using preoperative MRI in open- and closed-mouth positions.
- Patients who are willing and fully capable of complying with the study protocol.
Key exclusion criteria (3 listed)
- Participants will be excluded if they have:
- Bleeding disorders or are receiving anticoagulant medications. Pregnancy. Bony pathology of the temporomandibular joint. Temporomandibular disorder patients or patients with anterior disc displacement without reduction.
- Any temporomandibular joint infection. Mental instabilities or psychiatric conditions. Previous invasive or surgical procedures of the temporomandibular joint. Inability to attend follow-up during the entire follow-up period. Refusal to sign the written informed consent. Dystonia.
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 |
|---|---|---|
| PRF treatment groupParticipants in the I-PRF group will receive 1.5 cc of injectable platelet-rich fibrin (I-PRF) injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. Approximately 10 mL of blood will be withdrawn from the patient's antecubital fossa using vacuum tubes and centrifuged at 700 RPM for 3 minutes for I-PRF preparation. The resulting I-PRF will be transferred using a sterile 22-gauge 3 mL plastic syringe and injected into the retrocondylar tissues. In cases of bilateral involvement, the procedure will be repeated on the opposite side. | Drug | I-PRF Group |
| Dextrose 20% ProlotherapyParticipants in the control group will receive 1.5 mL of 25% hypertonic dextrose solution injected into the retrocondylar tissues of the temporomandibular joint at 0, 2, and 4 weeks. The solution will be mixed with 0.2 mL of local anaesthetic solution containing 2% mepivacaine hydrochloride with 1:20,000 levonordefrin. The substances will be injected under aseptic conditions using a 22-gauge needle. In cases of bilateral involvement, the procedure will be repeated on the opposite side. | Drug | Dextrose 25% Group |
Primary outcome
Improvement in the Position of the Articular Disc
Time frame: 6 months
Improvement in the position of the articular disc will be assessed by comparing preoperative and postoperative MRI measurements of disc position in both closed- and open-mouth positions.
3 secondary outcomes
Pain Intensity
Time frame: Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.
Maximum Mouth Opening (MMO)
Time frame: Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.
Temporomandibular Joint Clicking
Time frame: Preoperatively, 15 days after the first injection, 15 days after the second injection, 15 days after the third injection, 30 days after the third injection, 3 months after the third injection, and 6 months after the third injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing PRF treatment group and Dextrose 20% Prolotherapy in people with TMD, 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Improvement in the Position of the Articular Disc (time frame: 6 months). 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 1 Sep 2026.