A one-sided exact binominal test of proportions will be used to determine if the proportion of patients (π) that have bone formation assessed based on bone height measurements, in the grafted site after 6 months, as identified by CBCT imaging, will…
ID
Bron
Verkorte titel
Aandoening
Reduction of Jawbone
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary performance endpoint: The proportion of patients that has bone formation assessed based on bone height measurements, in the grafted site after 6 months, as identified by CBCT imaging.
Achtergrond van het onderzoek
This study is a single center, single cohort, non-randomized, open label clinical study to demonstrate the performance and safety of FF-37101, intended to support new bone formation in the maxillomandibular region. The study will target to implant 30 subjects with FF-37101 in order to follow at least 23 subjects for 6 months post-treatment.
Doel van het onderzoek
A one-sided exact binominal test of proportions will be used to determine if the proportion of patients (π) that have bone formation assessed based on bone height measurements, in the grafted site after 6 months, as identified by CBCT imaging, will be greater than 50%. If the p-value from this test is less than or equal to 0.05 then we will state that there is significant evidence to reject the null hypothesis that the proportion is less than or equal to 50% in favor of the alternative that the proportion is greater than 50%.
Onderzoeksopzet
0, 1 week, 2 weeks, 1 month, 2 months (phone contact), 3 months, 6 months
Onderzoeksproduct en/of interventie
Use of FF-37101 as bone graft scaffold after tooth extraction
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization.
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
• Full coverage restoration or large metallic restoration work including 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 this 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 enrollment.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8363 |
| CCMO | NL65005.028.19 |
| OMON | NL-OMON55475 |