Effect of Botox Injection in Anterior Belly of Digastric on Skeletal Relapse Following Mandibular Advancement Surgery

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05573581

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to test whether Botox injection in anterior belly of digastric muscle in BSSO for mandibular advancement surgery could reduce the tendency of postoperative relapse.

Research question:

(P) In patient has skeletal class II mandibular retrognathism, (I) will Botox injection in anterior belly of digastric. (O) Affect the relapse of the mandible after mandibular advancement orthognathic surgery?

Participants will be undergo Botox injection in anterior belly of digastric and bilateral sagittal split surgery

Condition or Disease	Intervention/Treatment	Phase
Orthognathic Relapse	Drug: Botox	Phase 3

Detailed Description

In the intervention group:

Botulinum toxin type A will be first injected into anterior belly of digastric muscles 2-3 days prior to any surgical intervention (for the BTX to be clinically effective). A total of 20 U of Botox will be injected bilaterally by using 25g needle, 1 cc insulin syringe through extra oral approach in 4 point.

Intra-operative procedures:

Access through a vestibular Sagittal split incision for mandible will be carried out. Dissection and reflection to reach the bone will be carried out.

The cutting guide of the mandible will be placed onto the exposed bony surface and manipulated to the best fit. Then, the guide will be fixed using four 2.0-mm screws to avoid any mobilization during drilling of the reference holes. Sixteen reference holes will be established using the cutting guide; eight on each side.
Then, a reciprocating saw will be used to perform the planned bilateral sagittal split osteotomy. After adequate mandibular mobilization and removal of bony interferences, the mandible will be repositioned using the patient-specific osteosynthesis material guided by the previously established reference holes and fixed using 2.0-mm screws.
In Bi-max surgery the maxillary cutting guide will be fixed in the same manner and Lefort I osteotomy will be carried out.
After adequate mobilization, the maxilla will be repositioned by the patient specific osteosynthesis material using the reference holes made by cutting guide and fixed using 2.0-mm screws.
All incisions were closed with 4-0 resorbable sutures.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized controlled trialrandomized controlled trial

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Botox Injection in Anterior Belly of Digastric on Skeletal Relapse Following Mandibular Advancement Surgery (Randomized Controlled Trial)

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botox injection group Botox injection in anterior belly of digastric before mandibular advancement orthognathic surgery	Drug: Botox Botulinum toxin type A will be first injected into anterior belly of digastric muscles 2-3 days prior to any surgical intervention (for the BTX to be clinically effective)(Sadick and Matarasso 2004). A total of 20 U of Botox will be injected bilaterally by using 25g needle, 1 cc insulin syringe through extraoral approach in 4 point Other Names: botulinum toxin type A
No Intervention: placebo group no injection before surgery

Arm

Intervention/Treatment

Experimental: Botox injection group

Botox injection in anterior belly of digastric before mandibular advancement orthognathic surgery

Drug: Botox

Botulinum toxin type A will be first injected into anterior belly of digastric muscles 2-3 days prior to any surgical intervention (for the BTX to be clinically effective)(Sadick and Matarasso 2004). A total of 20 U of Botox will be injected bilaterally by using 25g needle, 1 cc insulin syringe through extraoral approach in 4 point

Other Names:

botulinum toxin type A

No Intervention: placebo group

no injection before surgery

Outcome Measures

Primary Outcome Measures

relapse [6 month]
relapse in mandibular advancement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients need bilateral sagittal split osteotomy for correction of skeletal class II malocclusion (mandibular retrognathism).
Age of the patient above 18 years.
All patients are free from any systemic disease that may affect normal bone healing.

Exclusion Criteria:

Patient with history of facial bone trauma, cleft lip or palate.
Intra-bony lesions or infections that may interfere with surgery.
Previous orthognathic surgeries.
Patients with relative contraindications to (BTX) injection such as pregnancy, lactation, neuromuscular diseases (e.g., myasthenia gravis), motor neuron disease, allergy to any of the components of (BTX).