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

NCT05573581 | Unknown Phase 3 DMC

• 1 other identifier: 01147686914
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Conditions

Orthognathic Relapse

Keywords

mandibular advancement; orthognathic relapse

Outcome Measures

Primary Outcomes (1)

• relapse

  relapse in mandibular advancement

  6 month

Study Arms (2)

Botox injection group

EXPERIMENTAL

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

Drug: Botox

placebo group

NO INTERVENTION

no injection before surgery

Interventions

Botox DRUG

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

Also known as: botulinum toxin type A

Botox injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 12, 2022

Record last verified: 2022-10