An RCT Comparing Xenograft and Allograft for Ridge Preservation
This trial is active, not recruiting.
|Treatment||guided bone regeneration|
|Collaborator||Geistlich Pharma AG|
|Start date||April 2014|
|End date||September 2015|
|Trial size||40 participants|
|Trial identifier||NCT02330523, 13530232|
To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Bone ridge dimension
time frame: Six Months
Vital bone and mineral content at 6-months
time frame: Six Months
Wound closure at all study time points
time frame: surgery/ baseline; 1-week, 4-weeks, 3-months and 6-months (endpoint)
Male or female participants from 18 years up to 70 years old.
- Subjects 18 to 70-yrs of age
- Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing)
- Subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket
- Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- Subjects must be able and willing to follow study procedures and instructions.
- Subjects with a history of any tobacco use within the last six months.
- Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- Subjects taking intramuscular or intravenous bisphosphonates.
- Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic.
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration
- Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
- Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
|Official title||A Prospective, Randomized, Controlled, Multi-center Study With Direct Measure and Histological Evaluation Comparing Xenograft and Allograft for Posterior Buccal Dehiscence Extraction Site Ridge Preservation|
|Principal investigator||Eric T Scheyer, DDS, MS|
|Description||Buccal bony wall loss is a common sequela following tooth extraction, and guided bone regeneration (GBR) is a common treatment for the regeneration of ridge form and volume preservation allowing dental implant placement. Many bone augmentation biomaterials are employed to accomplish GBR, and both the medical/ dental community and, subsequently, patients benefit from understanding whether a given GBR biomaterial might be more efficacious. To this end, a randomized, case series comparison of allograft + x-linked collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to both the dental community and patients. The study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked collagen membrane with xenograft + non-x-linked collagen membrane for posterior region extraction socket ridge preservation.|
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