Clinical trial NCT02330523: An RCT Comparing Xenograft and Allograft for Ridge Preservation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Lead sponsor: McGuire Institute
Sponsor class: INDUSTRY
Collaborators: name: Geistlich Pharma AG
First posted: 2015-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
timeFrame: Six Months
Secondary outcomes:
measure: New Bone Plus Graft Content at 6-months
timeFrame: Six Months
measure: Wound Closure at 4-weeks
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
Study officials:
affiliation: The McGuire Institute
name: Eric T Scheyer, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cook DC, Mealey BL. Histologic comparison of healing following tooth extraction with ridge preservation using two different xenograft protocols. J Periodontol. 2013 May;84(5):585-94. doi: 10.1902/jop.2012.120219. Epub 2012 Jun 9.