Mandibular SurgeryNCT07104656
Bony Overlap Following Use of the Inferior Border Saw for the 'Low and Short' Sagittal Split: A Split-Mouth Study
A study testing Inferior Osteotomy made by border saw and Inferior Osteotomy made with reciprocating saw in people with Mandibular Surgery, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if use of an inferior border saw while making the inferior border osteotomy is associated with the medial cortex fracture pattern. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Mandibular Surgery
- What is being tested?
- Inferior Osteotomy made by border saw and Inferior Osteotomy made with reciprocating saw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to Aug 2027
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient's having mandible surgery
Who cannot join
- Severe dentofacial deformity secondary to a syndromic diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brian Kinard, 205-934-4507, briankinard@uabmc.edu
Brian Kinard
About this study
Official title: Evaluate How Use of an Inferior Border Saw While Making the Inferior Border Osteotomy During Sagittal Ramus Osteotomy Using the Low and Short Medial Osteotomy Modification Technique Affects the Lingual Fracture Pattern of the Mandible
The purpose of this study is to evaluate if use of an inferior border saw while making the inferior border osteotomy is associated with the medial cortex fracture pattern.
- Conditions
- Mandibular Surgery
- Being tested
- Inferior Osteotomy made by border saw, Inferior Osteotomy made with reciprocating saw
- Keywords
- Mandibular, osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Osteotomy made by border sawProcedure or surgery
Inferior border saw used to make the inferior border osteotomy
Inferior Osteotomy made with reciprocating sawProcedure or surgery
reciprocating saw used to make the inferior osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving right jaw surgery | Active comparator | Participants receiving inferior border saw on right jaw surgery Receives: Procedure: Inferior Osteotomy made by border saw; Procedure: Inferior Osteotomy made with reciprocating saw |
| Participants receiving left jaw surgery | Active comparator | Participants receiving inferior border saw on left jaw surgery Receives: Procedure: Inferior Osteotomy made by border saw; Procedure: Inferior Osteotomy made with reciprocating saw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type Medial Cortex Fracture Pattern
CT scan comparison of the lingual cortex of the mandible to evaluate the fracture pattern. Classified into 4 fracture patterns (Using the Lingual Split Scale.) On a scale of LSS1 vertical Fracture, LSS2 Horizontal Fracture, LSS3 Fracture along the mandibular canal, LSS4 unfavorable fracture. Where 1, 2, and 3 are favorable and 4 is unfavorable.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start7 Jan 2026
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular SurgeryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Kinard, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104656
- Sponsor's protocol ID
- IRB-300014869
- Other IDs
- UAB
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate How Use of an Inferior Border Saw While Making the Inferior Border Osteotomy During Sagittal Ramus Osteotomy Using the Low and Short Medial Osteotomy Modification Technique Affects the Lingual Fracture Pattern of the Mandible
- ClinicalTrials.gov ID
- NCT07104656
- Acronym / sponsor ID
- IRB-300014869
- Conditions
- Mandibular Surgery
- Keywords
- Mandibular, osteotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Aug 2025 (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 evaluate if use of an inferior border saw while making the inferior border osteotomy is associated with the medial cortex fracture pattern.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving right jaw surgery | Active comparator | Procedure: Inferior Osteotomy made by border saw, Procedure: Inferior Osteotomy made with reciprocating sawParticipants receiving inferior border saw on right jaw surgery |
| Participants receiving left jaw surgery | Active comparator | Procedure: Inferior Osteotomy made by border saw, Procedure: Inferior Osteotomy made with reciprocating sawParticipants receiving inferior border saw on left jaw surgery |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient's having mandible surgery
Key exclusion criteria (1 listed)
- Severe dentofacial deformity secondary to a syndromic diagnosis
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 |
|---|---|---|
| Inferior Osteotomy made by border sawInferior border saw used to make the inferior border osteotomy | Procedure or surgery | Participants receiving left jaw surgery, Participants receiving right jaw surgery |
| Inferior Osteotomy made with reciprocating sawreciprocating saw used to make the inferior osteotomy | Procedure or surgery | Participants receiving left jaw surgery, Participants receiving right jaw surgery |
Primary outcome
Type Medial Cortex Fracture Pattern
Time frame: 5 weeks
CT scan comparison of the lingual cortex of the mandible to evaluate the fracture pattern. Classified into 4 fracture patterns (Using the Lingual Split Scale.) On a scale of LSS1 vertical Fracture, LSS2 Horizontal Fracture, LSS3 Fracture along the mandibular canal, LSS4 unfavorable fracture. Where 1, 2, and 3 are favorable and 4 is unfavorable.
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 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 Inferior Osteotomy made by border saw and Inferior Osteotomy made with reciprocating saw in people with Mandibular Surgery, run by University of Alabama at Birmingham at 1 site in United States.
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 1 inclusion and 1 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 8 Oct 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 United States. 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 Brian Kinard (205-934-4507, briankinard@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type Medial Cortex Fracture Pattern (time frame: 5 weeks). 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 8 Oct 2026.