An interventional study of allograft + x-link collagen membrane and xenograft + non-x-link collagen in Tooth Loss, sponsored by McGuire Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-18.
Sponsored by McGuire Institute · Not applicable, Interventional, and Treatment
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.
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.
224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.
This study's enrollment of 40 is above the median of 30 across 166 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →McGuire Institute is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Device: allograft + x-link collagen membrane
Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Device: xenograft + non-x-link collagen
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. Allograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. X-link collagen membrane 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.
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. Xenograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. Non-x-link collagen membrane 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.
Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.
Time frame: Six Months
New Bone Plus Graft Content at 6-months
New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the "new healing" area.
Time frame: Six Months
Wound Closure at 4-weeks
Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.
Time frame: 4-weeks
Patients were recruited at all 9 investigation sites between October 2013 and June 2014.
| Milestone | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen |
|---|---|---|
| Started | 21 | 19 |
| Completed | 21 | 19 |
| Not completed | 0 | 0 |
The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.
| mm | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen |
|---|---|---|
| Bone Ridge Buccal-Lingual Width | 4.95 ± 2.65 | 6.71 ± 2.07 |
| Bone Ridge Apico-Coronal Height | 5.29 ± 3.73 | 6.24 ± 2.98 |
New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the "new healing" area.
| percentage of total area | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen |
|---|---|---|
| New Bone Plus Graft Content at 6-months | 46.14 ± 7.66 | 49.21 ± 8.27 |
Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.
| mm | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen |
|---|---|---|
| Wound Closure at 4-weeks | 2.26 ± 2.68 | 0.79 ± 1.55 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Allograft + X-link Collagen Membrane | — | 0/21 (0%) | 1/21 (4.8%) |
| Xenograft + Non-x-link Collagen | — | 0/19 (0%) | 0/19 (0%) |
| Event | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen |
|---|---|---|
| InfectionInfections and infestations | 1/21 | 0/19 |
| Age, Continuous(years) | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen | Total |
|---|---|---|---|
| Mean | 55.9 ± 10.7 | 55.3 ± 13.3 | 55.7 ± 11.8 |
| Sex: Female, Male(Participants) | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 11 | 10 | 21 |
| Region of Enrollment(participants) | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen | Total |
|---|---|---|---|
| United States | 21 | 19 | 40 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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