Temporomandibular Joint DisordersNCT07855887
Calcium Gluconate Activated in Anterior Disc Displacement With Reduction of the Temporomandibular Joint
A study testing activated platelet-rich plasma and non-activated platelet-rich plasma in people with Temporomandibular Joint Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the efficacy of retro discal injection of calcium gluconate-activated PRP versus non-activated PRP in adults with Anterior Disc Displacement with Reduction (ADDWR). Efficacy will be measured by the reduction of symptoms and the restoration of function, specifically targeting the normal Maximum Mouth Opening… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- activated platelet-rich plasma and non-activated platelet-rich plasma
- 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
- 25 Jul 2026to Nov 2026
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Clinical and MRI diagnosis of ADDWR per DCTMD criteria.
- Baseline VAS pain score 4-10.
- Failure of at least 2 conservative treatments (splint therapy, physiotherapy, NSAIDs) for 3 months.
- Written informed consent.
Who cannot join
- • Systemic inflammatory arthritis (Rheumatoid arthritis, etc.).
- Recent TMJ surgery or intra-articular injection within the last 6 months.
- Pregnancy or lactation.
- Active TMJ infection or malignancy.
- Coagulopathy or anticoagulant therapy.
- Contraindications to MRI (e.g., pacemaker).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Mohamed A. Osama, BDS, 01013127607, mohamed.madkour@dentistry.cu.edu.eg
Nada Abd El Sattar Mohamed Kotb, 01281679119, nada_abdelsattar@dentistry.cu.edu.eg
About this study
Official title: Calcium Gluconate Activated Versus Non-Activated Platelet Rich Plasma in Anterior Disc Displacement With Reduction of the Temporomandibular Joint: Randomized Clinical Trial.
To compare the efficacy of retro discal injection of calcium gluconate-activated PRP versus non-activated PRP in adults with Anterior Disc Displacement with Reduction (ADDWR). Efficacy will be measured by the reduction of symptoms and the restoration of function, specifically targeting the normal Maximum Mouth Opening (MMO) range
Read the detailed description
To compare the efficacy of retro discal injection of calcium gluconate-activated PRP versus non-activated PRP in adults with Anterior Disc Displacement With Reduction (ADDWR). Efficacy will be measured by the reduction of symptoms and the restoration of function, specifically targeting the normal Maximum Mouth Opening (MMO) range.
Although laboratory evidence indicates that activation with Calcium Gluconate significantly enhances growth factor release compared to non-activated (resting) PRP, it remains clinically unproven whether this biochemical advantage translates into superior symptomatic relief and functional disc repositioning in TMJ patients. This trial seeks to determine if the additional step of activation yields a statistically significant clinical benefit over the simpler, non-activated technique.
By combining the biologically optimized injectate (Calcium Gluconate-Activated PRP) with the anatomically specific retrodiscal injection site-which is critical for addressing disc instability-this study aims to define a superior, evidence-based protocol. Determining the efficacy of this specific combination is essential for establishing a "gold standard" for non-surgical ADDWR management.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- activated platelet-rich plasma, non-activated platelet-rich plasma
- 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.
activated platelet-rich plasmaProcedure or surgery
Intra-articular retrodiscal injection of autologous platelet-rich plasma (PRP) activated with 0.5 milliliters of 10% sterile calcium gluconate per 5 milliliters of prepared PRP, administered as a single anatomical landmark-guided injection into the retrodiscal tissue.
non-activated platelet-rich plasmaProcedure or surgery
Intra-articular retrodiscal injection of autologous non-activated platelet-rich plasma, prepared using identical double-centrifugation technique and administered using identical injection protocol and volume
| Study group | Role | What they receive |
|---|---|---|
| activated platelet-rich plasma | Experimental | Intra-articular retro discal injection of autologous platelet-rich plasma (PRP) Receives: Procedure: activated platelet-rich plasma |
| non-activated platelet-rich plasma | Active comparator | Intra-articular retrodiscal injection of autologous non-activated platelet-rich plasma Receives: Procedure: non-activated platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Interincisal Opening (MIO)
measuring in millimeters using ruler
Measured: 3 months
Secondary outcomes (2)
Pain Intensity
Visual Analog Scale (0-10)
Measured: 3 months
Return of disc to normal position
using MRI imaging
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start25 Jul 2026
- Primary completion25 Oct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Osama Madkour ElSayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855887
- Sponsor's protocol ID
- omfs-6-2026
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Gluconate Activated Versus Non-Activated Platelet Rich Plasma in Anterior Disc Displacement With Reduction of the Temporomandibular Joint: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07855887
- Acronym / sponsor ID
- omfs-6-2026
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jul 2026 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Oct 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.
To compare the efficacy of retro discal injection of calcium gluconate-activated PRP versus non-activated PRP in adults with Anterior Disc Displacement with Reduction (ADDWR). Efficacy will be measured by the reduction of symptoms and the restoration of function, specifically targeting the normal Maximum Mouth Opening (MMO) range
Detailed description
To compare the efficacy of retro discal injection of calcium gluconate-activated PRP versus non-activated PRP in adults with Anterior Disc Displacement With Reduction (ADDWR). Efficacy will be measured by the reduction of symptoms and the restoration of function, specifically targeting the normal Maximum Mouth Opening (MMO) range.
Although laboratory evidence indicates that activation with Calcium Gluconate significantly enhances growth factor release compared to non-activated (resting) PRP, it remains clinically unproven whether this biochemical advantage translates into superior symptomatic relief and functional disc repositioning in TMJ patients. This trial seeks to determine if the additional step of activation yields a statistically significant clinical benefit over the simpler, non-activated technique.
By combining the biologically optimized injectate (Calcium Gluconate-Activated PRP) with the anatomically specific retrodiscal injection site-which is critical for addressing disc instability-this study aims to define a superior, evidence-based protocol. Determining the efficacy of this specific combination is essential for establishing a "gold standard" for non-surgical ADDWR management.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| activated platelet-rich plasma | Experimental | Procedure: activated platelet-rich plasmaIntra-articular retro discal injection of autologous platelet-rich plasma (PRP) |
| non-activated platelet-rich plasma | Active comparator | Procedure: non-activated platelet-rich plasmaIntra-articular retrodiscal injection of autologous non-activated platelet-rich plasma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years.
- Clinical and MRI diagnosis of ADDWR per DCTMD criteria.
- Baseline VAS pain score 4-10.
- Failure of at least 2 conservative treatments (splint therapy, physiotherapy, NSAIDs) for 3 months.
- Written informed consent.
Key exclusion criteria (6 listed)
- • Systemic inflammatory arthritis (Rheumatoid arthritis, etc.).
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 |
|---|---|---|
| activated platelet-rich plasmaIntra-articular retrodiscal injection of autologous platelet-rich plasma (PRP) activated with 0.5 milliliters of 10% sterile calcium gluconate per 5 milliliters of prepared PRP, administered as a single anatomical landmark-guided injection into the retrodiscal tissue. | Procedure or surgery | activated platelet-rich plasma |
| non-activated platelet-rich plasmaIntra-articular retrodiscal injection of autologous non-activated platelet-rich plasma, prepared using identical double-centrifugation technique and administered using identical injection protocol and volume | Procedure or surgery | non-activated platelet-rich plasma |
Primary outcome
Maximal Interincisal Opening (MIO)
Time frame: 3 months
measuring in millimeters using ruler
2 secondary outcomes
Pain Intensity
Time frame: 3 months
Return of disc to normal position
Time frame: 3 months
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 2 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing activated platelet-rich plasma and non-activated platelet-rich plasma in people with Temporomandibular Joint Disorders, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Oct 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.
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?
Contact Mohamed A. Osama, BDS (01013127607, mohamed.madkour@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Interincisal Opening (MIO) (time frame: 3 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 2 Oct 2026.