Bone formation bone lesion
Conditions
Interventions
The tooth extraction will be completed according to standard of care. The
extraction socket will be thoroughly curetted and irrigated with a sterile 0.9%
saline solution. A buccal dehiscence will be
Sponsors
FUJIFILM Manufacturing Europe BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 year or older at time of informed consent. - Have 1 tooth (front, pre-molar or molar) of poor prognosis diagnosed for tooth extraction - Have 1 or more healthy tooth/teeth immediately adjacent to the tooth that is to be extracted - Have a type I or type II socket of the buccal alveolar bone of the tooth to be extracted - Absence of pockets of 5mm or more in the full dentition, with exception of the pocket of the tooth to be extracted. - Able to return for follow-up visits, as defined in this clinical investigation plan, after tooth extraction. - Scheduled to have an implant placed 6 months after tooth extraction and FF-37101 implantation
Exclusion criteria
Exclusion criteria: - Signs of active inflammation, i.e. presence of inflammatory fluid during tooth extraction - Active generalized periodontal disease; evident periapical radiolucencies or abscesses; autoimmune disorders; taking or having a history of bisphosphonate medications or Denosumab (history of MRONJ (medication-related osteonecrosis of the jaw)/BRONJ (bisphosphonate-related osteonecrosis of the jaw)); congenital or metabolic bone disorders; or uncontrolled diabetes. - Metal root pin or dental implant completed on any tooth adjacent to the tooth to be extracted in this clinical investigation - Current or former smoker or user of chewing tobacco or nicotine-containing products. Former smokers or users are defined as subjects who smoked 10 cigarettes or more (or an equivalent amount of other tobacco products) per day in the 5 years prior to screening - Females who are pregnant, breastfeeding, or are planning to conceive during their enrollment in the clinical investigation - History of any clinically significant mental and/or psychological, or other major disease, as determined by the investigator that would prevent dental treatment. - Inability to effectively communicate with study staff during the clinical investigation. - History of any severe allergic or anaphylactic reactions to collagen or gelatin, or current sensitivity to collagen or gelatin - Unwillingness or inability to comply with the requirements of the clinical investigation plan - Previous head and neck radiation- or chemo- therapy - Other reasons that, in the opinion of the investigator, will make the subject unsuitable for enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary performance endpoint will be the proportion of patients that has bone formation in the grafted site after 6 months, as identified by CBCT imaging, will be 50% or more. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary performance endpoint is the evidence of newly formed bone and its individual components, bone maturity, and soft tissue/marrow space, at 6 months post-treatment, identified by histologic analysis of biopsies of the pre-molar and molar teeth. The exploratory performance endpoints are: - The amount of bone that has been formed in the extraction socket assessed based on bone height measurements, at 3 months post-treatment, identified by cone beam computed tomography (CBCT) evaluation. - The amount of FF-37101 at 6 months post-treatment, identified by histologic analysis of biopsies of the pre-molar and molar teeth. - The implant stability quotient (ISQ) that is measured after placing the implant, identified by ISQ measurement devices. - The bone volume that has been formed in the extraction socket at 3 and 6 months post-treatment, identified by CBCT evaluation. Exploratory safety endpoint: The safety objectives of this study are to assess the safety of the device, by assessing the overall incidence of device related serious adverse events. Furthermore, the immunogenicity of R-collagen will be assessed by the detection of anti-device antibodies to R-collagen. Immunogenicity responses that show related clinical symptoms will be further investigated as part of the safety evaluation. | — |
Countries
Netherlands
Outcome results
None listed