None listed
Conditions
Brief summary
This is a double-blind, randomised, comparator-controlled, four (4) arm, prospective investigation. The primary objective of this clinical investigation is to identify the optimal configuration of TrimphDent required to produce a clinical outcome similar to or better than that of autologous bone graft. The secondary objective of the clinical investigation is to evaluate the safety and usability of TrimphDent.
Interventions
Gold-standard state of the art orthognathic jaw surgery involves application of autologous bone graft to a surgically cut bone, to stimulate natural bone growth and healing. TrimphDent is a synthetic bone graft substitute formulated from a synthetic polymer (PNPHO - 140 mg per 1 ml of sterile water) chemically crosslinked with a synthetic peptide Thymosin B4 (30 mg per 1 ml of PNPHO solution).
The approximate duration of the intervention is 2 hours.
TrimphDent will be administered by an oral and
Gold-standard state of the art orthognathic jaw surgery involves application of autologous bone graft to a surgically cut bone, to stimulate natural bone growth and healing. TrimphDent is a synthetic bone graft substitute formulated from a synthetic polymer (PNPHO - 140 mg per 1 ml of sterile water) chemically crosslinked with a synthetic peptide Thymosin B4 (30 mg per 1 ml of PNPHO solution). The approximate duration of the intervention is 2 hours. TrimphDent will be administered by an oral and maxillofacial or orthognathic surgeon. Clinical investigation participants will be randomised into one of four treatment groups; Treatment 1 - Trimph Dent including Thymosin ß4 (investigational) Treatment 2 - Trimph Dent including Thymosin ß4 and 0.15 mg/ml BMP-2 (investigational) Treatment 3 - Trimph Dent including Thymosin ß4 and 0.30 mg/ml BMP-2 (investigational) Treatment 4 - Standard of care autologous bone grafting
Sponsors
Trimph Technology Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Patients with any osteotomy width less than 8 mm or greater than 12 mm. Patients with chronic inflammation, out of range blood markers: o Erythrocyte sedimentation rate (ESR) above 22 mm for male and 29 mm for female candidates. o C-reactive proteins (CRP) above 5 mg/L. • Patients with low liver function, as indicated by: o ALT and AST level > 1.5 times the upper limit of normal (ULN). o Alkaline phosphatase above 140 IU/L. o INR below 0.8 or above 1.3. o Bilirubin above 1.2 mg/dL. • Patients with low kidney function, as indicated by: o Serum creatinine above 1.4 for both male and female (the norm for male is 1.4 and for female is 1.2). o Glomerular 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.
Outcome results
None listed