Trial Outcomes & Findings for Guided Bone Regeneration Around Immediate Implants (NCT NCT01628367)
NCT ID: NCT01628367
Last Updated: 2017-03-20
Results Overview
Change of buccal bone volume over study duration
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
One year
Results posted on
2017-03-20
Participant Flow
Double-group, parallel, single-blinded, randomize clinical trial
Forty-eight patients were consented and screened; 35 initially included then 3 excluded based on socket morphology after extraction. Final enrollment = 32
Participant milestones
| Measure |
Test
Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
|
Control
Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test
Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
|
Control
Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Guided Bone Regeneration Around Immediate Implants
Baseline characteristics by cohort
| Measure |
Test
n=16 Participants
Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
|
Control
n=16 Participants
Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Mean keratanized gingiva (KG) width
|
4.73 millimeters
STANDARD_DEVIATION 1.83 • n=5 Participants
|
3.63 millimeters
STANDARD_DEVIATION 1.93 • n=7 Participants
|
4.18 millimeters
STANDARD_DEVIATION 1.88 • n=5 Participants
|
|
Soft tissue thickness
4mm from free gingival margin (FGM)
|
.97 millimeters
STANDARD_DEVIATION .23 • n=5 Participants
|
1 millimeters
STANDARD_DEVIATION .18 • n=7 Participants
|
.985 millimeters
STANDARD_DEVIATION .59 • n=5 Participants
|
|
Soft tissue thickness
6mm from free gingival margin (FGM)
|
1.07 millimeters
STANDARD_DEVIATION .32 • n=5 Participants
|
1.09 millimeters
STANDARD_DEVIATION .2 • n=7 Participants
|
1.08 millimeters
STANDARD_DEVIATION .26 • n=5 Participants
|
|
Age, Customized
18 years old and older
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Buccal plate thickness
|
.93 millimeters
STANDARD_DEVIATION .46 • n=5 Participants
|
.75 millimeters
STANDARD_DEVIATION .26 • n=7 Participants
|
.84 millimeters
STANDARD_DEVIATION .36 • n=5 Participants
|
|
Lingual plate thickness
|
1.23 millimeters
STANDARD_DEVIATION .46 • n=5 Participants
|
.875 millimeters
STANDARD_DEVIATION .34 • n=7 Participants
|
1.0525 millimeters
STANDARD_DEVIATION .4 • n=5 Participants
|
|
Teeth
Maxillary Anteriors
|
5 Teeth
n=5 Participants
|
5 Teeth
n=7 Participants
|
10 Teeth
n=5 Participants
|
|
Teeth
Maxillary Premolars
|
9 Teeth
n=5 Participants
|
5 Teeth
n=7 Participants
|
14 Teeth
n=5 Participants
|
|
Teeth
Mandibular Premolars
|
2 Teeth
n=5 Participants
|
6 Teeth
n=7 Participants
|
8 Teeth
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearChange of buccal bone volume over study duration
Outcome measures
| Measure |
Test
n=15 Participants
Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
|
Control
n=16 Participants
Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
|
|---|---|---|
|
Change in Thickness of Buccal Bone
4mm from free gingival margin (FGM)
|
.73 millimeters
Standard Deviation .86
|
.86 millimeters
Standard Deviation .56
|
|
Change in Thickness of Buccal Bone
6mm from free gingival margin (FGM)
|
.63 millimeters
Standard Deviation .75
|
.66 millimeters
Standard Deviation .77
|
SECONDARY outcome
Timeframe: One yearChange of interproximal marginal bone loss (mean of mesial and distal sites)
Outcome measures
| Measure |
Test
n=15 Participants
Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
|
Control
n=16 Participants
Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
|
|---|---|---|
|
Change in Interproximal Bone Levels
|
1.38 millimeters
Standard Deviation .99
|
1.42 millimeters
Standard Deviation .66
|
SECONDARY outcome
Timeframe: One yearPink esthetic score per Furhauser et.al. measured at study conclusion where based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture (Fig. 1). Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. Thus a maximum score of 14 is best, and 0 is the worst.
Outcome measures
| Measure |
Test
n=15 Participants
Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
|
Control
n=16 Participants
Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
|
|---|---|---|
|
Pink Esthetic Score
|
11.53 units on a scale
Standard Deviation 1.13
|
9.88 units on a scale
Standard Deviation 2.13
|
Adverse Events
Test
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
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 |
Test
n=16 participants at risk
Membrane:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.
Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
|
Control
n=16 participants at risk
Collagen plug:
Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.
Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
|
|---|---|---|
|
Surgical and medical procedures
Implant Failure
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/16 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place