Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT06814535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin a on the Relief of Jaw Muscles Myofascial Pain
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 .
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 .
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: