TOS: TrimphDent for Orthognathic Surgery. A clinical investigation comparing the bone growth stimulation capability of TrimphDent (investigational product) and autologous bone grafting (use of patient's own bone) to in adults undergoing surgery to correct a defect of the jaw.
- Conditions
- Dentofacial Skeletal AnomaliesSurgery - Other surgeryMusculoskeletal - Other muscular and skeletal disordersOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12618000323224
- Lead Sponsor
- Trimph Technology Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 20
Participants 18 years of age or greater.
Participants with treatment plans including any osteotomy width between 8 mm and 12 mm.
Participants willing to give written informed consent and willing to participate in and comply with the study.
Patients with any osteotomy width less than 8 mm or greater than 12 mm.
Patients with chronic inflammation, out of range blood markers:
oErythrocyte sedimentation rate (ESR) above 22 mm for male and 29 mm for female candidates.
oC-reactive proteins (CRP) above 5 mg/L.
•Patients with low liver function, as indicated by:
oALT and AST level > 1.5 times the upper limit of normal (ULN).
oAlkaline phosphatase above 140 IU/L.
oINR below 0.8 or above 1.3.
oBilirubin above 1.2 mg/dL.
•Patients with low kidney function, as indicated by:
oSerum creatinine above 1.4 for both male and female (the norm for male is 1.4 and for female is 1.2).
oGlomerular filtration rate (GFR) of below 60 mL/min/1.73m2).
•Patients <18 years of age.
•Pregnant or lactating women, or women of childbearing potential who are not willing to avoid becoming pregnant during the study.
•Patients who are concurrently enrolled in another clinical study, or have received an investigational new drug within the past four (4) weeks.
•Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
•Patients unwilling or unlikely, in the Principal Investigator’s opinion, to comply with the study follow-up.
•Patients with an American Society of Anaesthesiologists (ASA) physical status classification of ASA 2 or greater.
•Patients who are undergoing or are to undergo an immunosuppressive therapy.
•Patients with active cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method