None listed
Conditions
Brief summary
Tooth extraction or loss results in resorption of bone volume in the jaw. This is a natural phenomenon which occurs mainly during the first 3 months following removal of the tooth. Preservation of bone volume facilitates subsequent placement of dental implants and leads to improved functional and aesthetic outcomes for patients. Guided bone regeneration (GBR) is a commonly used technique where a bone substrate (autologous or de-proteinised bovine bone matrix) is packed around the exposed implant to fill the defect, and covered with a membrane. The membrane promotes the growth of new bone by occluding infiltration of competing soft tissue, but permitting fluid and nutrient transfer to the newly forming bone. Native collagen membranes of porcine origin are commonly used as they have been proven to significantly enhance periodontal and bone regeneration in animal and human clinical studies. Celgro(tm) is an acellular type I/III collagen matrix of porcine origin. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens of porcine origin. Celgro(tm) is a next-generation membrane that is manufactured using collagen originating from animals bred and exclusively raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of Celgro(tm) is mechanically stronger and more elastic than other collagen membrane products of this type. This study proposes to use Celgro(tm) in a standardised dental implantation procedure to assess its suitability for use in GBR.
Interventions
Patients who are undergoing dental implant surgery with bone augmentation will receive Celgro(tm) collagen membrane as a part of the bone augmentation procedure instead of a commercially-available collagen membrane. The membrane is placed in the jaw during implant placement surgery, which is a single occasion.
Sponsors
Orthocell Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Participant requires one or more dental implants with simultaneous bone augmentation procedure - Tooth extraction procedure was performed prior to simultaneous augmentation procedure with no complications - Female participants of child-bearing potential must: *Have a negative pregnancy test within 72 hours of visit 1 *Agree not to fall pregnant while on the study - Non-smoker - Able to comply with the requirements of the protocol, including post-operative oral hygiene and attendance for follow-up procedures - Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP
Exclusion criteria
- Insulin-dependent, uncontrolled or poorly-controlled diabetes mellitus - History of malignancy, radiotherapy or chemotherapy within the last 5 years - Female participant who is pregnant or lactating - Participant is taking medication that may have an effect on bone turnover or mucosal healing - General contraindications for dental and/or surgical treatment - Concurrent disease or medical condition which affects bone or connective tissue metabolism - Known hypersensitivity to collagen - Known substance abuse - Participation in another study with an investigational product within previous 3 months - Other clinically significant disease (including psychological disorders) or medical condition that would, in the opinion of the investigator, compromise the safety or the participant or the outcome of the study
Outcome results
None listed