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Clinical Trials in Egypt / NCT06814535
Active, not recruiting Phase 2/3

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

NCT06814535 · tracked via the Priya Life Science Egypt tracker
Sponsor
Cairo University
Phase
Phase 2/3
Started
2024-06-01
Last updated
2025-03-11

Condition(s) studied

Patients with Jaw Muscles Myofascial Pain

Investigational drug(s) / intervention(s)

Botulinum Toxin A / Botulinum Toxin APlatelet rich plasma →Saline -- placebo comparator

Botulinum Toxin A / Botulinum Toxin A: Botulinum toxin type A

Platelet rich plasma: Plasma that contains concentrated platelets

Saline -- placebo comparator: Physiological saline .9 %

Study summary

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 .

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: * patient with myofascial trigger points in masseter or temporalis previously ----\*identified by manual palpation. * 18 years or More "Willingness to follow instructions. Exclusion Criteria: * therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint. * Clinical conditions as pregnancy * Medical problems that will interfere with the procedure as bleeding disorders. * Cognitive impairment or present inadequate cooperation.

Primary outcome measure(s)

  • Pressure pain threshold — 3 months
    The amount of force per kilogram needed to induce pain in patients with myofascial pain at the trigger point.. Will be measured using the algometer which presses on the trigger point to induce pain by force measured in kilograms/cm2 If the reading increased among the treatment visits , this means better outcome and decreased pain intensity with effectiveness of the treatment
  • Current pain intensity — 3 months
    The amount of pain on VAS at the time of examination from 0-10 With 0 no pain which increases to reach 10 ( the highest pain intensity).. Decrease in pain intensity means better outcome
  • Worst pain intensity — 3 months
    The worst pain the patient had suffered from on the previous duration. Using visual analogue scale from (0-10) with 0 least pain and 10 worst pain . Decrease in pain intensity means better outcome

Trial sites (1)

FacilityCityRegionStatus
Faculty of dentistry Cairo University Giza Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06814535 on ClinicalTrials.gov ↗ ← All trials in Egypt