Overview

This trial is active, not recruiting.

Condition tooth loss
Treatment guided bone regeneration
Sponsor McGuire Institute
Collaborator Geistlich Pharma AG
Start date April 2014
End date September 2015
Trial size 40 participants
Trial identifier NCT02330523, 13530232

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
guided bone regeneration
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.
(Active Comparator)
Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
guided bone regeneration
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.

Primary Outcomes

Measure
Bone ridge dimension
time frame: Six Months

Secondary Outcomes

Measure
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)

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by McGuire Institute.