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NCT05673655

Intraoral Injection of Trigger Points by Botox

Status unknown Phase 2 Last updated 10 January 2023
What this trial tests

Phase 2 trial testing intraoral trigger point injection by botox in Myofacial Pain in 40 participants. Status unknown.

Timeline
25 December 2022
Primary endpoint
1 February 2023
25 February 2023

Quick facts

Lead sponsorFayoum University
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date25 December 2022
Primary completion1 February 2023
Estimated completion25 February 2023
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Fayoum University

Who can join

Adults 18 to 60, any sex, with Myofacial Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with orofacial pain lasting at least 3 months. The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected Botox at each trigger point according to the treatment group by the same operator. Patients will be examined by a blinded investigator at pre- and post-injections at the following intervals: during diagnosis, 1 week, 4, and 6 weeks post-injection. The patients will be assessed using a pain score measured on a 10-point visual analog scale (VAS). The secondary outcome assessed will be measuring the quality of life in an Oral Health Impact Profile questionnaire (OHIP-14).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effectiveness of intra-oral botulinum toxin injection in comparison to the extra-oral approach on pain and quality of life in patients with myofascial pain: a randomized clinical trial.
    Shabaan AA, Kassem I, Aboulmagd I, Amer IA, et al · · 2024 · cited 1× · PMID 39681752 · DOI 10.1007/s00784-024-06051-0

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Other recruiting trials for Myofacial Pain

Currently open trials in the same condition.

Other Fayoum University trials

Trials by the same sponsor.

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