None listed
Conditions
Brief summary
TrimphDent is an injectable biomaterial for use in dental and maxillofacial applications. TrimphDent consists of two components: (1) the Trimph smart synthetic polymer and (2) a peptide (Thymosin B4). The use of TrimphDent as a regenerative scaffold is aimed to: a) stimulate new bone regeneration following tooth extraction. b) negate the need for bone harvesting operations or other bone grafting procedures following tooth extraction c) reduce post-operative infections risks following oral surgery. This initial pilot study will enrol ten (10) patients from one (1) centre in Western Australia, The study is being conducted in conjunction with standard of care procedures in patients undergoing tooth extraction with subsequent planned dental implant procedure. The primary objective of this pilot study is to identify qualitative measures and analytical methodologies to further investigator the use of TrimphDent. This will be done using three methods including: oral examination, histological evaluation and CT-imaging. These methodologies will be utilised to evaluate bone regeneration in the presence of TrimphDent following tooth extraction.
Interventions
Single application of experimental device, TrimphDent, by injection. TrimphDent is an injectable biomaterial consisting of a synthetic polymer and peptide, Thymosin B4, chemically bonded to create a single uniform molecule.
Between 0.5ml and 2ml of TrimphDent will be injected to fill the empty dental socket immediately after tooth-extraction. The amount of TrimphDent to be injected (i.e. between 0.5ml and 2ml) is dependent on the size of the empty dental socket and this is based on clinical
Single application of experimental device, TrimphDent, by injection. TrimphDent is an injectable biomaterial consisting of a synthetic polymer and peptide, Thymosin B4, chemically bonded to create a single uniform molecule. Between 0.5ml and 2ml of TrimphDent will be injected to fill the empty dental socket immediately after tooth-extraction. The amount of TrimphDent to be injected (i.e. between 0.5ml and 2ml) is dependent on the size of the empty dental socket and this is based on clinical judgment. Application of TrimphDent will be performed by an experienced Dental Implant Surgeon and Specialist Periodontist. It is expected that TrimphDent will remain in-situ permanently as it stimulates and interfaces with both tissue regeneration.
Sponsors
Trimph Industries Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patients greater than 18 years of age. - Patients undergoing a planned tooth extraction. - Patients willing to give written informed consent and willing to participate and comply with the study.
Exclusion criteria
- Patients with chronic inflammation as assessed by clinical laboratory assessments. - Patients with low liver function as assessed by clinical laboratory assessments. - Patients with low kidney function as assessed by clinical laboratory assessments. - Pregnant or lactating women, or women of childbearing potential who are not willing to avoid becoming pregnant during the study. - Patients with a history of disease that is likely to interfere with the normal post-operative healing process.
Outcome results
None listed