Trial Outcomes & Findings for An RCT Comparing Xenograft and Allograft for Ridge Preservation (NCT NCT02330523)
NCT ID: NCT02330523
Last Updated: 2016-02-18
Results Overview
The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Six Months
Results posted on
2016-02-18
Participant Flow
Patients were recruited at all 9 investigation sites between October 2013 and June 2014.
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An RCT Comparing Xenograft and Allograft for Ridge Preservation
Baseline characteristics by cohort
| Measure |
Allograft + X-link Collagen Membrane
n=21 Participants
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.
|
Xenograft + Non-x-link Collagen
n=19 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
55.3 years
STANDARD_DEVIATION 13.3 • n=107 Participants
|
55.7 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
19 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Six MonthsThe primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.
Outcome measures
| Measure |
Allograft + X-link Collagen Membrane
n=21 Participants
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.
|
Xenograft + Non-x-link Collagen
n=19 Participants
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.
|
|---|---|---|
|
Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
Bone Ridge Buccal-Lingual Width
|
4.95 mm
Standard Deviation 2.65
|
6.71 mm
Standard Deviation 2.07
|
|
Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
Bone Ridge Apico-Coronal Height
|
5.29 mm
Standard Deviation 3.73
|
6.24 mm
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: Six MonthsNew 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.
Outcome measures
| Measure |
Allograft + X-link Collagen Membrane
n=21 Participants
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.
|
Xenograft + Non-x-link Collagen
n=19 Participants
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.
|
|---|---|---|
|
New Bone Plus Graft Content at 6-months
|
46.14 percentage of total area
Standard Deviation 7.66
|
49.21 percentage of total area
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: 4-weeksSuture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.
Outcome measures
| Measure |
Allograft + X-link Collagen Membrane
n=21 Participants
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.
|
Xenograft + Non-x-link Collagen
n=19 Participants
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.
|
|---|---|---|
|
Wound Closure at 4-weeks
|
2.26 mm
Standard Deviation 2.68
|
0.79 mm
Standard Deviation 1.55
|
Adverse Events
Allograft + X-link Collagen Membrane
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Xenograft + Non-x-link Collagen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Allograft + X-link Collagen Membrane
n=21 participants at risk
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.
|
Xenograft + Non-x-link Collagen
n=19 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Infection
|
4.8%
1/21 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place