Trial Outcomes & Findings for Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen® (NCT NCT03659617)
NCT ID: NCT03659617
Last Updated: 2026-09-03
Results Overview
For participants that had implant placement, this outcome is determined via clinical evaluation of the number of participants that still had their 1 implant in place after 3 Years. Note: Only 1 implant was placed per participant.
COMPLETED
NA
42 participants
3 years after implant placement
2026-09-03
Participant Flow
Participant milestones
| Measure |
Implant Placement 3 Months After Tooth Extraction
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
Implant Placement 6 Months After Tooth Extraction
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
Implant Placement 9 Months After Tooth Extraction
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
3
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
7
|
Reasons for withdrawal
| Measure |
Implant Placement 3 Months After Tooth Extraction
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
Implant Placement 6 Months After Tooth Extraction
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
Implant Placement 9 Months After Tooth Extraction
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
5
|
|
Overall Study
Adverse Event
|
4
|
3
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Implant Placement 3 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
Implant Placement 6 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
Implant Placement 9 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=14 Participants
|
8 Participants
n=14 Participants
|
9 Participants
n=14 Participants
|
26 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
5 Participants
n=14 Participants
|
16 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
8 Participants
n=14 Participants
|
9 Participants
n=14 Participants
|
25 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
5 Participants
n=14 Participants
|
17 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
42 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 3 years after implant placementPopulation: 11 subjects from Group A (Implant placement 3 months after tooth extraction), 8 subjects from Group B (Implant placement 6 months after tooth extraction), and 7 subjects from Group C (Implant placement 9 months after tooth extraction) did not attend this visit/were lost to follow-up/were excluded from the study, so data was not collected.
For participants that had implant placement, this outcome is determined via clinical evaluation of the number of participants that still had their 1 implant in place after 3 Years. Note: Only 1 implant was placed per participant.
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=6 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=7 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=3 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Number of Participants That Had an Implant That Survived 3 Years After Implant Placement
|
6 participants
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 9 monthsPopulation: One bone biopsy in group A (Alveolar ridge preservation using xenograft and implant placement at 3 months) was too deteriorated for histological processing, so it was discarded.
After histological staining, median percent of mineralized tissue (vital bone) was calculated by appearance using ImageJ (NIH, open-source software).
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Median Percentage of Mineralized Tissue (Vital Bone)
|
33.33 percent of mineralized tissue
Interval 0.49 to 56.21
|
37.05 percent of mineralized tissue
Interval 9.53 to 68.85
|
13.53 percent of mineralized tissue
Interval 0.0 to 59.62
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 9 monthsPopulation: One bone biopsy in group A (Implant Placement 3 Months After Tooth Extraction) was too deteriorated for histological processing, so it was discarded.
Median percentage of non-mineralized tissue: Following histological staining, the percentage of non-mineralized tissue was calculated using ImageJ (NIH, open-source software). The total tissue area was measured, and the percentages of mineralized tissue and residual xenograft material were subtracted from the total area. The remaining area was reported as the percentage of non-mineralized tissue.
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Median Percentage of Non-mineralized Tissue
|
55.5 percentage of non-mineralized tissue
Interval 36.01 to 81.98
|
52.48 percentage of non-mineralized tissue
Interval 29.84 to 62.2
|
63.32 percentage of non-mineralized tissue
Interval 38.5 to 85.93
|
SECONDARY outcome
Timeframe: Baseline, Final Follow-Up (4 weeks before implant placement)When compared to baseline, determine if there is a change in median bone width reduction (at 1, 3, 5mm apical to bone crest) for each group (implant placement 3 months after tooth extraction, implant placement 6 months after tooth extraction, implant placement 9 months after tooth extraction), which will be measured using clinical and radiographic (via CBCT) assessment. To calculate change, the final follow-up value for each group is subtracted from the baseline value.
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Median Change in Bone Width Reduction (at 1, 3, 5mm Apical to Bone Crest) From Final Follow-up to Baseline for Each Group
Horizontal ridge width at 1mm.
|
-1.35 millimeters
Interval -4.0 to -0.2
|
-1.5 millimeters
Interval -4.2 to -0.2
|
-1.2 millimeters
Interval -4.2 to -0.4
|
|
Median Change in Bone Width Reduction (at 1, 3, 5mm Apical to Bone Crest) From Final Follow-up to Baseline for Each Group
Horizontal ridge width at 3mm.
|
-0.6 millimeters
Interval -2.7 to 0.0
|
-1.5 millimeters
Interval -3.0 to -0.3
|
-0.85 millimeters
Interval -1.5 to 0.0
|
|
Median Change in Bone Width Reduction (at 1, 3, 5mm Apical to Bone Crest) From Final Follow-up to Baseline for Each Group
Horizontal ridge width at 5mm.
|
-0.3 millimeters
Interval -1.5 to 0.0
|
-1.2 millimeters
Interval -4.2 to 0.0
|
-0.45 millimeters
Interval -2.0 to 0.0
|
|
Median Change in Bone Width Reduction (at 1, 3, 5mm Apical to Bone Crest) From Final Follow-up to Baseline for Each Group
Vertical mid-facial bone height.
|
-0.5 millimeters
Interval -1.5 to -0.2
|
-0.4 millimeters
Interval -2.2 to 0.6
|
-0.6 millimeters
Interval -2.0 to -0.3
|
|
Median Change in Bone Width Reduction (at 1, 3, 5mm Apical to Bone Crest) From Final Follow-up to Baseline for Each Group
Vertical mid-lingual bone height.
|
-0.45 millimeters
Interval -1.4 to -0.1
|
-0.3 millimeters
Interval -1.8 to -0.1
|
-0.4 millimeters
Interval -1.7 to 0.4
|
SECONDARY outcome
Timeframe: 1 week following tooth extraction and alveolar ridge preservationPopulation: 2 subjects from Group A (Implant placement 3 months after tooth extraction) were not able to attend 1-week visit, so data was not collected, resulting in 12 subjects for Group A.
Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=12 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® at 1 Week, Using a Wound Healing Index (1-3 Scale Rating)
|
1.14 units on a scale
Interval 1.0 to 2.0
|
1.14 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 2 weeks following tooth extraction and alveolar ridge preservationPopulation: 2 subjects from Group A (Implant placement 3 months after tooth extraction) and 1 subject from Group B (Implant placement 6 months after tooth extraction) were not able to attend 2-week visit, so this data was not collected.
Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=12 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® @ 2 Weeks, Using a Wound Healing Index (1-3 Scale Rating)
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 6 weeks following tooth extraction and alveolar ridge preservationPopulation: 1 subject from Group A (Implant placement 3 months after tooth extraction), 2 subjects from Group B (Implant placement 6 months after tooth extraction), and 1 subject from Group C (Implant placement 9 months after tooth extraction) were not able to attend this visit, so no data was collected.
Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=12 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® at 6 Weeks, Using a Wound Healing Index (1-3 Scale Rating)
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 2 weeks following dental implant placementPopulation: 2 subjects from Group A (Implant placement 3 months after tooth extraction) and 1 subject from Group B (Implant placement 6 months after tooth extraction), and 1 subject from Group C (Implant placement 9 months after tooth extraction) were not able to attend 2-week visit, so this data was not collected.
Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=12 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Assessment of the Mucosal Maturation Following Implant Placement, Using a Wound Healing Index (1-3 Scale Rating)
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 1 week following tooth extraction and alveolar ridge preservationPopulation: 2 subjects from Group A (Implant placement 3 months after tooth extraction) were not able to attend 1-week visit, so data was not collected, resulting in 12 subjects for Group A.
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=12 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Patient Reported Outcomes (Pain) 1 Week Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
|
10.64 score on a scale
Interval 0.0 to 66.0
|
14.85 score on a scale
Interval 0.0 to 67.0
|
9.91 score on a scale
Interval 1.0 to 29.0
|
SECONDARY outcome
Timeframe: 2 weeks following tooth extraction and alveolar ridge preservationPopulation: 2 subjects from Group A (Implant placement 3 months after tooth extraction) and 1 subject from Group B (Implant placement 6 months after tooth extraction) were not able to attend this visit, so this data was not collected.
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=12 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Patient Reported Outcomes (Pain) 2 Weeks Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
|
4.3 score on a scale
Interval 0.0 to 20.0
|
1.5 score on a scale
Interval 0.0 to 8.0
|
2.16 score on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: 6 weeks following tooth extraction and alveolar ridge preservationPopulation: 1 subject from Group A (Implant placement 3 months after tooth extraction), and 1 subject from Group C (Implant placement 9 months after tooth extraction) was not able to attend this visit, so this data was not collected.
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=14 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Patient Reported Outcomes (Pain) 6 Weeks Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)
|
1.58 score on a scale
Interval 0.0 to 4.0
|
3.07 score on a scale
Interval 0.0 to 20.0
|
2.23 score on a scale
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: 2 weeks following implant placementPopulation: 2 subjects from Group A (Implant placement 3 months after tooth extraction) and 1 subject from Group B (Implant placement 6 months after tooth extraction), and 1 subject from Group C (Implant placement 9 months after tooth extraction) were not able to attend this visit, so this data was not collected.
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=13 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=12 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Patient Reported Outcomes (Pain) 2 Weeks Following Implant Placement, Using a Visual Analog Score for Pain (0-100)
|
10.15 score on a scale
Interval 0.0 to 69.0
|
10.84 score on a scale
Interval 0.0 to 70.0
|
4.83 score on a scale
Interval 1.0 to 33.0
|
SECONDARY outcome
Timeframe: Up to 30 days post implant crown deliveryPopulation: 9 subjects from Group A (Implant placement 3 months after tooth extraction), 6 subjects from Group B (Implant placement 6 months after tooth extraction), and 6 subjects from Group C (Implant placement 9 months after tooth extraction) did not attend this visit, so data was not collected.
The patients will be asked to rate their satisfaction in terms of function using a Visual Analog Scale (0-100, with 0 meaning "not at satisfied at all" and 100 corresponding to "perfectly satisfied").
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=8 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=8 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=5 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Patient Reported Outcomes (Patient Satisfaction), Using a Visual Analog Scale (0-100)
|
94.375 score on a scale
Interval 55.0 to 100.0
|
98.62 score on a scale
Interval 95.0 to 100.0
|
98 score on a scale
Interval 95.0 to 100.0
|
SECONDARY outcome
Timeframe: Implant Crown Delivery, 3 years post implant crown deliveryPopulation: 11 subjects from Group A (Implant placement 3 months after tooth extraction), 8 subjects from Group B (Implant placement 6 months after tooth extraction), and 7 subjects from Group C (Implant placement 9 months after tooth extraction) did not attend this visit/were lost to follow-up/were excluded from the study, so data was not collected.
Measured in millimeters based on standardized intra-oral radiographs at crown placement and 3 years after crown placement. Negative values depicts bone levels below fixpoint (implant platform) meaning "true" bone loss. Positive values denotes bone levels above fixpoint meaning minimum remodeling following implant placement.
Outcome measures
| Measure |
Implant Placement 6 Months After Tooth Extraction
n=6 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=7 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
Implant Placement 3 Months After Tooth Extraction
n=3 Participants
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
|---|---|---|---|
|
Change in Marginal Bone Level From Crown Placement to 3 Years After Crown Placement.
|
-0.25 millimeters
Interval -0.67 to 0.59
|
-0.29 millimeters
Interval -0.65 to 0.36
|
0.49 millimeters
Interval -0.27 to 1.11
|
Adverse Events
Implant Placement 3 Months After Tooth Extraction
Implant Placement 6 Months After Tooth Extraction
Implant Placement 9 Months After Tooth Extraction
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Implant Placement 3 Months After Tooth Extraction
n=14 participants at risk
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction
|
Implant Placement 6 Months After Tooth Extraction
n=14 participants at risk
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction
|
Implant Placement 9 Months After Tooth Extraction
n=14 participants at risk
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction
|
|---|---|---|---|
|
Product Issues
Implant Failure
|
28.6%
4/14 • 3 Years
|
21.4%
3/14 • 3 Years
|
14.3%
2/14 • 3 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place