Orthognathic RelapsePhase 3NCT05573581
Effect of Botox Injection in Anterior Belly of Digastric on Skeletal Relapse Following Mandibular Advancement Surgery
A Phase 3 study testing Botox in people with Orthognathic Relapse, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Relapse
- What is being tested?
- Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Effect of Botox Injection in Anterior Belly of Digastric on Skeletal Relapse Following Mandibular Advancement Surgery (Randomized Controlled Trial)
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
Read the 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.
- Conditions
- Orthognathic Relapse
- Being tested
- Botox
- Keywords
- mandibular advancement, orthognathic relapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Also called botulinum toxin type A
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
| Study group | Role | What they receive |
|---|---|---|
| Botox injection group | Experimental | Botox injection in anterior belly of digastric before mandibular advancement orthognathic surgery Receives: Drug: Botox |
| placebo group | No intervention | no injection before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse
relapse in mandibular advancement
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic RelapseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aya abd el rhman abd el atty, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573581
- Sponsor's protocol ID
- 01147686914
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Botox Injection in Anterior Belly of Digastric on Skeletal Relapse Following Mandibular Advancement Surgery (Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT05573581
- Acronym / sponsor ID
- 01147686914
- Conditions
- Orthognathic Relapse
- Keywords
- mandibular advancement, orthognathic relapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Botox injection group | Experimental | Drug: BotoxBotox injection in anterior belly of digastric before mandibular advancement orthognathic surgery |
| placebo group | No intervention | –no injection before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotoxAlso: botulinum toxin type ABotulinum 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 | Drug | Botox injection group |
Primary outcome
relapse
Time frame: 6 month
relapse in mandibular advancement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Related trials for Orthognathic Relapse
Recruiting
Mandibular Medial Osteotomy Modifications and Postoperative Stability
Orthognathic Surgical Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botox in people with Orthognathic Relapse, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.