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NCT06814535
A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain
Phase 2, PHASE3 trial testing Botulinum Toxin A / Botulinum Toxin A in Patients with Jaw Muscles Myofascial Pain in 60 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2025
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 June 2024 |
| Primary completion | 31 March 2025 |
| Estimated completion | 31 March 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Botulinum Toxin A / Botulinum Toxin A — full drug profile →
- Platelet rich plasma — full drug profile →
- Saline -- placebo comparator
Conditions studied
- Patients with Jaw Muscles Myofascial Pain — all drugs for Patients with Jaw Muscles Myofascial Pain →
Sponsor
Cairo University
Who can join
Adults 18 to 60, any sex, with Patients with Jaw Muscles Myofascial Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain . The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles. The 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles. The 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles. The 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug . At the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers. Then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06814535 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cairo University
- Last refreshed: 11 March 2025
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