N/A
N=40
An RCT Comparing Xenograft and Allograft for Ridge Preservation
Tooth Loss
Bottom Line
View on ClinicalTrials.gov: NCT02330523 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months — 4.95; 6.71; 5.29; 6.24 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- allograft + x-link collagen membrane (Device); xenograft + non-x-link collagen (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- McGuire Institute
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months |
4.95; 6.71; 5.29; 6.24 | — |
| SECONDARY New Bone Plus Graft Content at 6-months |
46.14; 49.21 | — |
| SECONDARY Wound Closure at 4-weeks |
2.26; 0.79 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02330523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.