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.
Inclusion Criteria: 1. Subjects 18 to 70-yrs of age 2. Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing) 3. 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 4. Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF). 5. Subjects must be able and willing to follow study procedures and instructions. Exclusion Criteria: 1. Subjects with a history of any tobacco use within the last six months. 2. 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. 3. Subjects taking intramuscular or intravenous bisphosphonates. 4. Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic. 5. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration 6. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental). 7. 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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