Calcium Gluconate Activated in Anterior Disc Displacement With Reduction of the Temporomandibular Joint
Calcium Gluconate Activated Versus Non-Activated Platelet Rich Plasma in Anterior Disc Displacement With Reduction of the Temporomandibular Joint: Randomized Clinical Trial.
1 other identifier
interventional
20
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2026
CompletedFirst Submitted
Initial submission to the registry
September 28, 2026
CompletedFirst Posted
Study publicly available on registry
October 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
October 2, 2026
September 1, 2026
3 months
September 28, 2026
September 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Maximal Interincisal Opening (MIO)
measuring in millimeters using ruler
3 months
Secondary Outcomes (2)
Pain Intensity
3 months
Return of disc to normal position
3 months
Study Arms (2)
activated platelet-rich plasma
EXPERIMENTALIntra-articular retro discal injection of autologous platelet-rich plasma (PRP)
non-activated platelet-rich plasma
ACTIVE COMPARATORIntra-articular retrodiscal injection of autologous non-activated platelet-rich plasma
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's degree Student
Study Record Dates
First Submitted
September 28, 2026
First Posted
October 2, 2026
Study Start
July 25, 2026
Primary Completion (Estimated)
October 25, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
October 2, 2026
Record last verified: 2026-09