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

ConditionTemporomandibular Joint Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • activated platelet-rich plasma

    Procedure/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 plasma

    Procedure/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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: activated platelet-rich plasmaExperimental treatment 1 intervention
Group B: non-activated platelet-rich plasmaActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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