Condylar FracturesNCT07374341
The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of Condylar and Subcondylar Fractures
A study testing BOTOX Cosmetic® and Closed reduction and intermaxillary fixation in people with Condylar Fractures and Subcondylar Fracture, run by Pakinam Gheeta at 1 site in Egypt.
Trial summary
The aim of this study, is to evaluate the effectiveness of ultrasound guided injection of botulinum toxin A into the muscles of mastication; the masseter, temporalis and the lateral pterygoid, in a closed reduction approach of condylar and sub-condylar fractures, seeking to shed light on the efficacy and potential… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Condylar Fractures, Subcondylar Fracture
- What is being tested?
- BOTOX Cosmetic® and Closed reduction and intermaxillary fixation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having unilateral extra-capsular condylar/ sub-condylar fractures isolated or associated with other fractures.
- Isolated intra-capsular fractures.
- Moderate condylar displacement, JO to 45 degrees or incomplete fractures.
- Reproducible occlusion without drop-back or with drop-back that returns to midline on release of posterior force.
- Availability of more than half of the dentition
Who cannot join
- Bilateral condylar fractures
- Gross condylar displacement> 45 degrees (severely displaced)
- Anatomic reduction of ramus height 2: 2 mm
- Unstable occlusion (e.g., periodontal disease, less than three teeth per quadrant)
- Patients with severe polytraumas.
- Patients with relative contraindications to BTX injections that may include; pregnancy, lactation, BTX Allergies and presence of infection at the injection site.
- Patients with motor neuron diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University, Egypt
Alexandria
Pakinam Gheeta, BDS, +20 11 15568102, p.sameeh150115@alexu.edu.eg
About this study
Official title: The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of Condylar and Subcondylar Fractures (Randomized Controlled Clinical Trial)
The aim of this study, is to evaluate the effectiveness of ultrasound guided injection of botulinum toxin A into the muscles of mastication; the masseter, temporalis and the lateral pterygoid, in a closed reduction approach of condylar and sub-condylar fractures, seeking to shed light on the efficacy and potential advantages of this innovative therapeutic avenue.
- Conditions
- Condylar Fractures, Subcondylar Fracture
- Being tested
- BOTOX Cosmetic®, Closed reduction and intermaxillary fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOX Cosmetic®Other
The BTX vile is diluted with 2.0 cc saline or distilled water. It is 5 BU (Botox) per 0.1cc, so it is easy to measure (for 2.5 cc normal saline, you can calculate as 4 BU per 0.1 cc) therefore, the investigators can easily adjust the amount to be injected into the muscles of Mastication. Using a 5 cc syringe, draw more than 3 cc of air and inject into the botulinum toxin vial. Check whether the air is sucked into the vial. If air is not sucked into the vial, the vial is discarded as the vacuum is not present in the vial, thus it is faulty. To achieve a desirable concentration of dilution solution, an injection of 2.5 cc of normal saline into botulinum toxin and then it is gently mixed. Two to Three days prior to the surgical intervention, the BTX will be injected to the muscles of mastication; the lateral pterygoid, the masseter and temporal is of the fractured site. The, closed reduction and intermaxillary fixation will be performed for fracture management.
Closed reduction and intermaxillary fixationProcedure or surgery
All patients will be treated using the closed reduction and intermaxillary fixation method. The patients will be treated under local or general anesthesia depending on the availability of other concomitant fractures and general status of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation | Experimental | Not described Receives: Other: BOTOX Cosmetic®; Procedure: Closed reduction and intermaxillary fixation |
| Conventional treatment | Active comparator | Not described Receives: Procedure: Closed reduction and intermaxillary fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Measured: up to 2 weeks
Occlusion Assessment
Assessment of the Occlusion will be performed and given a score:
- Same to pre-traumatic
- Minor difference
- Functional malocclusion
- Needs occlusal correction
- Gross malocclusion.
Measured: up to 3 months
Mouth opening
Inter-incisal distance will be measured in (cm) using a ruler, to assess the degree of mouth opening.
Measured: up to 3 months
Mouth deviation assessment
The status of the deviation preoperatively, for the example the availability of cross bites or minor deviations, will be compared to the statues three months postoperatively. Photographs will be obtained for all patients to document occlusion and mouth opening.
Measured: up to 3 months
Time frame needed until the intermaxillary fixation (IMF) is removed
The Intermaxillary fixation will be removed once satisfactory occlusion was achieved and time frame of the IMF will be recorded for each patient.
Measured: through study completion, an average of 6 months
Bone density at the fracture line
An immediate postoperative CT will be obtained, followed by another one taken after 6 months postoperatively. The mean bone density at the fracture line in the 6 months CT-scan will be compared with the immediate postoperative and the preoperative scans and the mean difference between the scans will be calculated.
Measured: 6 months
The angle between fracture and the longitudinal axis of the ramus
An immediate postoperative CT will be obtained, followed by another one taken after 6 months postoperatively. The angle between the condylar or subcondylar fracture, and the longitudinal axis of the ramus will be measured and compared pre-operatively and six months post operatively and the difference will be calculated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start10 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Condylar FracturesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakinam Gheeta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pakinam Gheeta, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374341
- Sponsor's protocol ID
- 9239261
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gheeta PH, Elashwah AA, Younis PA. The effectiveness of guided botulinum toxin "A" injection to the masticatory muscles in the management of condylar and sub condylar fractures: a randomized controlled clinical trial. BMC Oral Health. 2026 Oct 12;26(1):1985. doi: 10.1186/s12903-026-09906-y.
PubMed 42864625
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of Condylar and Subcondylar Fractures (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07374341
- Acronym / sponsor ID
- 9239261
- Conditions
- Condylar Fractures, Subcondylar Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Pakinam GheetaUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 28 Jan 2026 (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 aim of this study, is to evaluate the effectiveness of ultrasound guided injection of botulinum toxin A into the muscles of mastication; the masseter, temporalis and the lateral pterygoid, in a closed reduction approach of condylar and sub-condylar fractures, seeking to shed light on the efficacy and potential advantages of this innovative therapeutic avenue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation | Experimental | Other: BOTOX Cosmetic®, Procedure: Closed reduction and intermaxillary fixation |
| Conventional treatment | Active comparator | Procedure: Closed reduction and intermaxillary fixation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having unilateral extra-capsular condylar/ sub-condylar fractures isolated or associated with other fractures.
- Isolated intra-capsular fractures.
- Moderate condylar displacement, JO to 45 degrees or incomplete fractures.
- Reproducible occlusion without drop-back or with drop-back that returns to midline on release of posterior force.
- Availability of more than half of the dentition
Key exclusion criteria (7 listed)
- Bilateral condylar fractures
- Gross condylar displacement> 45 degrees (severely displaced)
- Anatomic reduction of ramus height 2: 2 mm
- Unstable occlusion (e.g., periodontal disease, less than three teeth per quadrant)
- Patients with severe polytraumas.
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 |
|---|---|---|
| BOTOX Cosmetic®The BTX vile is diluted with 2.0 cc saline or distilled water. It is 5 BU (Botox) per 0.1cc, so it is easy to measure (for 2.5 cc normal saline, you can calculate as 4 BU per 0.1 cc) therefore, the investigators can easily adjust the amount to be injected into the muscles of Mastication. Using a 5 cc syringe, draw more than 3 cc of air and inject into the botulinum toxin vial. Check whether the air is sucked into the vial. If air is not sucked into the vial, the vial is discarded as the vacuum is not present in the vial, thus it is faulty. To achieve a desirable concentration of dilution solution, an injection of 2.5 cc of normal saline into botulinum toxin and then it is gently mixed. Two to Three days prior to the surgical intervention, the BTX will be injected to the muscles of mastication; the lateral pterygoid, the masseter and temporal is of the fractured site. The, closed reduction and intermaxillary fixation will be performed for fracture management. | Other | Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation |
| Closed reduction and intermaxillary fixationAll patients will be treated using the closed reduction and intermaxillary fixation method. The patients will be treated under local or general anesthesia depending on the availability of other concomitant fractures and general status of the patient. | Procedure or surgery | Conventional treatment, Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation |
Primary outcome
Postoperative pain
Time frame: up to 2 weeks
Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Occlusion Assessment
Time frame: up to 3 months
Assessment of the Occlusion will be performed and given a score: 1. Same to pre-traumatic 2. Minor difference 3. Functional malocclusion 4. Needs occlusal correction 5. Gross malocclusion.
Mouth opening
Time frame: up to 3 months
Inter-incisal distance will be measured in (cm) using a ruler, to assess the degree of mouth opening.
Mouth deviation assessment
Time frame: up to 3 months
The status of the deviation preoperatively, for the example the availability of cross bites or minor deviations, will be compared to the statues three months postoperatively. Photographs will be obtained for all patients to document occlusion and mouth opening.
Time frame needed until the intermaxillary fixation (IMF) is removed
Time frame: through study completion, an average of 6 months
The Intermaxillary fixation will be removed once satisfactory occlusion was achieved and time frame of the IMF will be recorded for each patient.
Bone density at the fracture line
Time frame: 6 months
An immediate postoperative CT will be obtained, followed by another one taken after 6 months postoperatively. The mean bone density at the fracture line in the 6 months CT-scan will be compared with the immediate postoperative and the preoperative scans and the mean difference between the scans will be calculated.
The angle between fracture and the longitudinal axis of the ramus
Time frame: 6 months
An immediate postoperative CT will be obtained, followed by another one taken after 6 months postoperatively. The angle between the condylar or subcondylar fracture, and the longitudinal axis of the ramus will be measured and compared pre-operatively and six months post operatively and the difference will be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 42864625Gheeta PH, Elashwah AA, Younis PA. The effectiveness of guided botulinum toxin "A" injection to the masticatory muscles in the management of condylar and sub condylar fractures: a randomized controlled clinical trial. BMC Oral Health. 2026 Oct 12;26(1):1985. doi: 10.1186/s12903-026-09906-y.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOTOX Cosmetic® and Closed reduction and intermaxillary fixation in people with Condylar Fractures and Subcondylar Fracture, run by Pakinam Gheeta at 1 site in Egypt.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pakinam Gheeta, BDS (+20 11 15568102, p.sameeh150115@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: up to 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374341, which also lists 1 linked publication.
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 28 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.