Bio-Oss Collagen Graft for Tooth Loss
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect bone metabolism, like certain bisphosphonates or glucocorticoids.
What data supports the effectiveness of the treatment Bio-Oss Collagen for tooth loss?
Is Bio-Oss Collagen Graft safe for humans?
How is the Bio-Oss Collagen treatment for tooth loss different from other treatments?
Bio-Oss Collagen is unique because it uses a natural bovine bone mineral that helps in bone conduction, promoting bone growth in areas where teeth have been lost. This treatment is often combined with a collagen membrane to enhance periodontal regeneration, making it different from other treatments that may not use these specific materials or methods.128910
What is the purpose of this trial?
The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites.Subjects with single rooted teeth planned for extraction and replacement with endosseous dental implants will be recruited for the study based on the eligibility criteria and will be divided in three groups (Groups 1, 2 and 3).A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the ridge dimensions, the tooth planned for extraction as well as the adjacent sites. After tooth extraction, the socket will be grafted with Bio-Oss Collagen® and, depending on the morphology of the extraction sockets, a collagen matrix (Mucograft® seal) and/or a restorable collagen membrane (BioGide®)will be placed to cover and stabilize the graft. Patients will return at 2 and 6 weeks post-extraction to evaluate the healing. A second CBCT will be obtained 2 weeks prior to implant placement to evaluate the ridge dimensions and compare them to the baseline data. Implant placement will take place at 12, 24 and 36 after tooth extraction for Groups 1, 2 and 3 respectively. A bone core biopsy will be obtained at the time of implant placement and will be sent for histological analysis. Patients will return for a post-operative visit at two weeks. Clinical indices (probing depth, recession, bleeding upon probing, keratinized mucosa height, plaque and gingival index), patient reported outcomes and marginal bone levels via standardized periapical radiographs will be evaluated and recorded at baseline (no more than 30 days following delivery of final implant restoration) 1, 2 and 3 years post-loading.
Research Team
Carlos Garaicoa Pazmino, DDS
Principal Investigator
University of Iowa
Eligibility Criteria
This trial is for adults needing a single-rooted tooth (not mandibular incisors) extracted and replaced with an implant. Candidates should be in good health, able to undergo dental procedures, and willing to sign consent. Exclusions include severe bone diseases, significant organ impairments, heavy smokers, pregnant or nursing women, those on certain medications affecting bone metabolism.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Tooth Extraction and Ridge Preservation
Tooth extraction and socket grafting with Bio-Oss Collagen®
Post-operative Monitoring
Post-operative visits to assess healing and remove sutures
Implant Placement
Placement of dental implants and bone core biopsy
Follow-up
Participants are monitored for safety and effectiveness after implant placement
Treatment Details
Interventions
- Bio-Oss Collagen
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gustavo Avila-Ortiz DDS, MS, PhD
Lead Sponsor
Theodoros Katsaros, DDS, MSD
Lead Sponsor
University of Iowa
Lead Sponsor
Geistlich Pharma AG
Industry Sponsor