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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allograft + x-link collagen membrane | Active Comparator | Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction. |
|
| xenograft + non-x-link collagen | Active Comparator | Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allograft + x-link collagen membrane | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric T Scheyer, DDS, MS | The McGuire Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perio Health Professionals | Houston | Texas | 77063 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22680300 | Background | 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. |
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Patients were recruited at all 9 investigation sites between October 2013 and June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Allograft + X-link Collagen Membrane | 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. |
| FG001 | Xenograft + Non-x-link Collagen | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allograft + X-link Collagen Membrane | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm | Six Months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allograft + X-link Collagen Membrane | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | Healing was "as expected" for both treatment modalities; no AEs occurred that could be attributed to the study, though 1 subject presented with a localized infection with suppuration at the test site (DFDBA+RECXC) and was treated with antibiotics. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| E. Todd Scheyer DDS, MS | The McGuire Institute | 713-783-544 | etsperio@swbell.net |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D014184 | Transplantation, Homologous |
| D014183 | Transplantation, Heterologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| xenograft + non-x-link collagen | Device | 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. |
|
| 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. | 4-weeks |
| BG001 | Xenograft + Non-x-link Collagen | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Xenograft + Non-x-link Collagen | 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of total area | Six Months |
|
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | mm | 4-weeks |
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| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Xenograft + Non-x-link Collagen | 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. | 0 | 19 | 0 | 19 |
|
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