Orthognathic surgery, cases of Bilateral Sagittal Split Osteotomy (B.S.S.O) of the mandible to achieve facial and occlusal balance. This could create bone gaps or continuity defects. These bone gaps can be small or quite large. Failure to graft these gaps can result in instability, relapse, and nonunion of the bone structures with subsequent redevelopment or worsening of the original deformity.
Conditions
Interventions
Product Name: recombinant soluble human tissue factor
Product Code: rshTF
Pharmaceutical Form: Solution for injection
Current Sponsor code: rshTF
Other descriptive name: thromboplastin or CD142
Concen
Sponsors
Henogen s.a.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with no hematological disorders, between 18 and 70 years old, requiring Bilateral Sagittal Split Osteotomy (BSSO) for repositioning of the mandible to achieve facial and occlusal balance and able to understand an informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - All exclusion criteria that apply for general anesthesia - Bone graft failure within a year - Hematological disorder - Clinically relevant cardiovascular disorder - Severe hypertension - Diabetes mellitus - Acute or chronic infection at the application site - Severe allergic rhinitis requiring permanent medication - History or presence of local or systemic malignant disease - Patient requiring chemo- or radiotherapy of the head - Chronic liver disorder (aspartate aminotransferase and/or alaninaminotransferase over 2 times upper limit of normal) - Impaired renal function (creatinine over 1.5 times upper limit of normal) - Clinically relevant symptoms of thyroid dysfunction - Known infection of Human Immunodeficiency Virus , Hepatitis B Virus or Hepatitis C Virus - Aspirin or Aspirin derived history 2 weeks before intervention - NSAID intolerance - Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Assessment of the efficacy of rshTF combined to a biosubsitute (Bio-Oss®, Geistlich) on mandible bone consolidation. - Assessment of the efficacy of rshTF combined to a collagen membrane (Bio-Gide®, Geistlich) on gingival cicatrisation. ;Secondary Objective: - Assessment of the safety of rshTF placed into the mandible.;Primary end point(s): Efficacy endpoints: - Quality of bone regeneration 6 and 24 weeks after surgery - Quality of gingival cicatrisation 6 and 24 weeks after surgery | — |
Countries
Belgium
Outcome results
None listed