Tooth Extraction
Conditions
Keywords
TT-173, Topical Hemostatics, Hemostasis
Brief summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.
Detailed description
As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety, tolerability and efficacy of TT-113 in healthy volunteers after tooth extraction.
Interventions
DRUGPlacebo
It is applied directly to the bleeding site after tooth extraction
DRUGTT-173
It is applied directly to the bleeding site after tooth extraction
Sponsors
Thrombotargets Europe S.L
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects to be undertaken for the simple extraction of at least one tooth (incisor, canine, premolar, molar different of third molar) that cause bloody wound, located in the upper or inferior maxillary area of the mouth either * Subjects who are able and willing to provide written and signed informed consent * All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits. Negative pregnancy test result in the screening visit.
Exclusion criteria
* Subjects with personal and family history that could affect correct hemostasis * Subjects with any clinically-significant coagulation disorder including including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura * Subject with hipersensivity of TT-173 of any of its components or has a known allergy. * Subjects who are unable to adequately follow or understand the instructions and requirements of the study. * Subjects that are not fully free to give informed consent, or any other obstacle in the opinion of investigator support the conclusion that the subject is not fully reasoned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax, Tmax, AUC and bioavailability | 48 h | — |
| Determine the presence of coagulation disorders | 4 months | Blood platelets, Prothrombin time, Fibrinogen, Thrombin time |
| Determine the immune responses to TT-173 | 4 months | Antibody concentration |
| Time to hemostasis until cessation of bleeding | time 0 until cessation of bleeding | — |
Countries
Spain
Outcome results
None listed