A Single-Center, Single-Cohort Study of FF-37101 for Bone Formation in the Maxillomandibular Regio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 28

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary performance endpoint will be the proportion of patients that has<br /><br>bone formation in the grafted site after 6 months, as identified by CBCT<br /><br>imaging, will be 50% or more. </p><br>

Secondary Outcome Measures

Name	Time	Method

Related Trials