The primary performance objective is to demonstrate bone formation assessed based on bone height measurements, in the maxillomandibular region after filling extraction sockets with FF-37101. Secondary and exploratory performance objectives of this…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Extraction of a tooth is generally indicated when a tooth cannot be restored or
maintained in acceptable conditions for long term health, function, and/or
esthetics. Tooth loss may have a direct impact on quality of life by impairing
the ability to speak, masticate, and in some instances, socialize. In addition,
the absence of a tooth triggers a cascade of biological events that typically
result in significant local anatomic changes. It is well known that after tooth
extraction, jawbone having supported the tooth undergoes significant reduction.
The severe reduction in the size of jawbone negatively affects the prosthetic
treatment, such as fixed bridge, removable denture and dental implant.
FUJIFILM has developed a new oral bone graft material, FF-37101, which intends
to support new bone formation in the maxillomandibular region, including bone
formation in the tooth extraction socket, sinus lift, periodontal defects, and
other indications. FF-37101 is composed of sponge like granules that are
manufactured from recombinant collagen (R-collagen) specifically designed for
this product. On implantation, it is theorized that the FF-37101 pores act to
absorb blood and form and stabilize the clot. The collagen sponge acts as a
scaffold for new bone formation. Once placed in the bone defect area such as
the tooth extraction socket, FF-37101 is gradually resorbed by the body*s
natural enzymes, while new bone formation occurs within and along the surface
of the FF-37101. The material is intended to be completely absorbed after
implantation with replacement by new bone.
Preclinical testing has shown the potential of the investigational device for
its intended use in humans. However, no clinical studies have been performed on
FF-37101 to date, nor are there any equivalent products available on the market
to establish the safety and performance of FF-37101 in humans. In order to
prove the safety and performance of FF-37101 in healthy adult subjects for bone
formation in the maxillomandibular region, this study will be conducted.
FUJIFILM has chosen socket preservation as a suitable method for determining
the performance of FF-37101 for bone formation in the maxillomandibular region.
Study objective
The primary performance objective is to demonstrate bone formation assessed
based on bone height measurements, in the maxillomandibular region after
filling extraction sockets with FF-37101.
Secondary and exploratory performance objectives of this study are:
• To evaluate bone maturity and bone formation at 6 months post-treatment.
• To evaluate bone formation assessed based on bone height measurements, in the
grafted site after filling of extraction sockets with FF-37101 at 3 months
post-treatment.
• To evaluate FF-37101 resorption in the extraction socket at 6 months after
FF-37101 implantation.
• To evaluate primary implant stability of the implant placed at 6 months
post-treatment.
• To evaluate bone formation assessed based on bone volume measurements, in the
grafted site after filling of extraction sockets with FF-37101 at 3 and 6
months post-treatment.
The safety objectives of this study are to assess the safety of the device by
assessing the overall incidence of serious adverse device effects.
Study design
This is a single-center, single cohort, non-randomized, open-label study of
FF-37101 following the extraction of a hopeless tooth (front, pre-molar or
molar) to demonstrate the safety and performance of the FF-37101 device in
adult subjects.
All subjects included in the study and that fulfill the inclusion and exclusion
criteria will be treated with FF-37101. No comparator or other treatments will
be used in this clinical investigation. Subjects will be followed up for 6
months.
Intervention
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 examined clinically using
periodontal probe and explorer immediately after extraction and the buccal bone
loss will be recorded in mm. FF-37101 will swell when it comes into contact
with blood or saline. FF-37101 will be pre-soaked with sterile 0.9% saline
solution or the subject*s blood before the implantation. After the pre-soaking,
the extraction socket will then be filled with FF-37101. FF-37101 granules in
the socket will be gently compressed to fill to the soft tissue edge. Caution
will be used not to over pack FF-37101 into the socket and avoid granule
fragmentation. The wound is closed using sutures. If possible, no membrane will
be utilized during or following placement of FF-37101. The decision of the use
of a membrane will be up to the investigator for the success of the surgery.
Study burden and risks
The subjects are expected to visit the clinic for an initial screening visit.
Subsequently, during visit 1 the actual tooth extraction and FF-37101
implantation are performed and afterwards 5 follow up visits (2-6) and an
intermediate telephone contact will be scheduled. During all visits and the
intermediate telephone contact, safety of the FF-37101 device will be
evaluated.
At visit 1, 5 and 6 a cone beam computed tomography (CBCT) will be taken. A
CBCT-scan uses X-rays. The total radiation exposure is will be about 00.0075
mSv (0.0025 mSv for each scan). For comparison: the background radiation in the
Netherlands is ~2,5 mSv each year.
At visit 6 a biopsy is taken for subjects treated for pre-molar and molar
teeth.
Blood (7 ml) will be drawn for immunogenicity testing during visit 1, 4, 5 and
6. If immunogenicity testing results are available and classified as positive,
subjects will be asked to provide an extra blood sample and to conduct an extra
phone contact visit. Subjects shall be informed that the extra blood sample and
phone contact visit are additional and that they are free to reject
participation.
Based on all preclinical testing, the Sponsor anticipates the following adverse
device effects:
• Allergic reaction to R-collagen/FF-37101.
• Superficial wound infection.
• Deep wound infection.
• Loss or migration of the graft material.
Participation in this research will have the following benefits for the subject:
- Potential improved healing and bone formation, to facilitate further
treatment for dental restoration, such as prosthetic treatment.
- state-of-the-art diagnostic examinations
- partial reimbursement of dental treatments, until placement of the first part
of the implant
The sponsor believes that any potential risk presented by this investigation
has been minimized and that adequate testing, safeguards, and safety monitoring
have been incorporated into the investigation to further minimize and mitigate
the risks. FUJIFILM Manufacturing Europe BV firmly believes that the benefits
of FF-37101 outweigh the potential risks posed to participating subjects.
Oudenstaart 1 1
Tilburg 5000 LJ
NL
Oudenstaart 1 1
Tilburg 5000 LJ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65005.028.19 |
| Other | NL8363 |
| OMON | NL-OMON24676 |