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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcutaneous injection | Active Comparator |
| |
| intraoral injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraoral trigger point injection by botox | Drug | intraoral injection of trigger point of masseter muscle by botulinum toxin |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain score | The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever. | 6 weeks post injection |
| Measure | Description | Time Frame |
|---|---|---|
| (OHIP-14) scale | OHIP-14 is used to measure patients' self-reported discomfort, disability, and functional limitation due to oral conditions with scores ranging from 0 to 56 (with 56 representing a subject answering ''very often'' to all 14 items | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum University | Al Fayyum | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39681752 | Derived | Shabaan AA, Kassem I, Aboulmagd I, Amer IA, Shaaban A, Abd-El-Ghafour M, Refahee SM. 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. Clin Oral Investig. 2024 Dec 17;29(1):18. doi: 10.1007/s00784-024-06051-0. |
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| transcutaneous trigger point injection by botox | Drug | transcutaneous injection of masseter muscle by botulinum toxin |
|