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RecruitingNCT07855887Updated Oct 2, 2026

Calcium Gluconate Activated in Anterior Disc Displacement With Reduction of the Temporomandibular Joint

An interventional study of activated platelet-rich plasma and non-activated platelet-rich plasma in Temporomandibular Joint Disorders, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Cairo University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 2 months later.
Updated Oct 2, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 (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.

02

Conditions studied

  • Temporomandibular Joint Disorders
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's planned enrollment of 20 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

    • 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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    activated platelet-rich plasma

    Intra-articular retro discal injection of autologous platelet-rich plasma (PRP)

    Procedure: activated platelet-rich plasma

  • Active comparator
    non-activated platelet-rich plasma

    Intra-articular retrodiscal injection of autologous non-activated platelet-rich plasma

    Procedure: non-activated platelet-rich plasma

Interventions

  • Procedureactivated platelet-rich plasma

    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.

  • Procedurenon-activated platelet-rich plasma

    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

06

What researchers measure

Primary outcomes

  1. Maximal Interincisal Opening (MIO)

    measuring in millimeters using ruler

    Time frame: 3 months

Secondary outcomes

  1. Pain Intensity

    Visual Analog Scale (0-10)

    Time frame: 3 months

  2. Return of disc to normal position

    using MRI imaging

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07855887
Lead sponsor
Cairo University
Responsible party
Mohamed Ahmed Osama Madkour ElSayed (Master's degree Student, Cairo University) — Principal investigator
First posted
Oct 2, 2026
Start date
Jul 25, 2026
Primary completion
Oct 25, 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Oct 2, 2026

Study contacts

Mohamed A. Osama, BDS
Contact
mohamed.madkour@dentistry.cu.edu.eg
01013127607

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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