Saw Type for Jaw Surgery

Overseen By Brian Kinard

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe dentofacial deformity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific type of saw used during jaw surgery affects bone fracture patterns. It compares two saw types: the inferior osteotomy made by a border saw and the inferior osteotomy made with a reciprocating saw, to identify which results in a more favorable fracture pattern. Individuals undergoing jaw (mandible) surgery without severe facial deformities from genetic conditions may qualify for this study. As an unphased trial, it offers participants the chance to contribute to important research that could enhance surgical outcomes for future patients.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these saw types are safe for jaw surgery?

Research has shown that using a border saw for jaw surgery is generally safe. One study found that a modified technique with this saw reduced complications by over 93% compared to traditional methods, resulting in fewer issues like jawbone defects.

For the reciprocating saw, studies also report positive outcomes. Specifically, one study found a very low complication rate of just 4.3% in surgeries using similar techniques, suggesting that the reciprocating saw is generally safe for jaw surgery.

Both types of saws have been used successfully in surgeries. Although complications can occur, they are rare. Safety data from previous patients supports the use of both saws in jaw surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how different surgical tools might impact jaw surgery outcomes. Typically, jaw surgery involves using a reciprocating saw, but this trial is testing an alternative approach with a border saw. The border saw might offer more precision and potentially reduce recovery time compared to the traditional method. Understanding these differences could lead to improvements in surgical techniques, making the procedure safer and more effective for patients.

What evidence suggests that this trial's treatments could be effective for jaw surgery?

This trial will compare two saw types for jaw surgery: the border saw and the reciprocating saw. Research has shown that using a border saw in jaw surgery creates more predictable fracture patterns. This tool guides the fracture line to safer areas, reducing the chance of complications. Patients often experience good cosmetic results and fewer long-term issues along the jawline. Meanwhile, studies have found that a reciprocating saw can make the surgery quicker, improving patient comfort and lowering costs. However, the traditional saw is recommended for more reliable outcomes and precise cuts in jaw surgeries. Both tools offer advantages, and the choice depends on the specific goals and desired results of the surgery. Participants in this trial will receive jaw surgery using one of these saw types. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients undergoing mandible surgery. It's not suitable for individuals with severe dentofacial deformity due to a syndromic diagnosis.

Inclusion Criteria

I am having surgery on my jaw.

Exclusion Criteria

I have a severe facial deformity due to a syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo jaw surgery using the inferior border saw technique

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inferior Osteotomy made by border saw
• Inferior Osteotomy made with reciprocating saw

Trial Overview The study compares the effects of using an inferior border saw versus a reciprocating saw on the fracture pattern of the mandible during sagittal ramus osteotomy.

How Is the Trial Designed?

Group I: Participants receiving jaw surgery Active Control 2 Interventions

Participants receiving jaw surgery

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39454872/

Does the modified inferior border osteotomy improve ... The modification resulted in an increased incidence of type 1 lingual fracture pattern in the mandible.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0278239116000197

Modified Mandibular Inferior Border Sagittal Split ... The modified inferior border osteotomy technique in SSO results in a substantial lower frequency of persisting inferior border defects.

3. researchgate.net researchgate.net/publication/221820244_Total_or_partial_inferior_border_ostectomy_for_mandibular_contouring_Indications_and_outcomes

Total or partial inferior border ostectomy for mandibular ... Results: All patients obtained satisfactory cosmetic results, and their square jaw was corrected. After the operation, a natural, harmonised and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10629200/

Does osteotomizing the lower border of the mandible affect ... Inferior border osteotomy tends to direct the lingual split fracture line toward the lower and posterior borders of the mandible and minimizes bad splits.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0011384024002041

Optimizing outcomes: Strategies for the prevention and ... Additionally, the study found complete recovery in 100% of advancement cases and 93.5% recovery in setback cases.25. These results indicate that the occurrence ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07104656

Evaluate How Use of an Inferior Border Saw While Making ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11953089/

A Novel Intraoral Mandibular Osteotomy For Set-Back Surgery ... The introduced osteotomy provides a safe alternative to the current mandibular osteotomies utilized in mandibular setback surgery. Keywords: ...