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Guided Bone Regeneration Around Immediate Implants

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ClinicalTrials.gov Identifier: NCT01628367
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : February 10, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Missing Tooth
Interventions Procedure: Minimally Traumatic Tooth Extraction
Device: Immediate Implant Placement
Biological: Bone Graft Placement
Biological: Membrane placement
Biological: Collagen plug placement
Drug: Medications
Enrollment 32
Recruitment Details Double-group, parallel, single-blinded, randomize clinical trial
Pre-assignment Details Forty-eight patients were consented and screened; 35 initially included then 3 excluded based on socket morphology after extraction. Final enrollment = 32
Arm/Group Title Test Control
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 16 16
Completed 15 16
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Test Control Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
18 years old and older Number Analyzed 16 participants 16 participants 32 participants
16 16 32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
8
  50.0%
8
  50.0%
16
  50.0%
Male
8
  50.0%
8
  50.0%
16
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Hispanic or Latino
0
   0.0%
1
   6.3%
1
   3.1%
Not Hispanic or Latino
16
 100.0%
15
  93.8%
31
  96.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
  18.8%
3
   9.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  12.5%
0
   0.0%
2
   6.3%
White
14
  87.5%
12
  75.0%
26
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   6.3%
1
   3.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 32 participants
16 16 32
Mean keratanized gingiva (KG) width   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 16 participants 16 participants 32 participants
4.73  (1.83) 3.63  (1.93) 4.18  (1.88)
[1]
Measure Description: Width of the keratinized gingiva at one study site
Soft tissue thickness  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 16 participants 16 participants 32 participants
4mm from free gingival margin (FGM) .97  (.23) 1  (.18) .985  (.59)
6mm from free gingival margin (FGM) 1.07  (.32) 1.09  (.2) 1.08  (.26)
Buccal plate thickness   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 16 participants 16 participants 32 participants
.93  (.46) .75  (.26) .84  (.36)
[1]
Measure Description: Thickness of the buccal plate measured clinically at the study site
Lingual plate thickness   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 16 participants 16 participants 32 participants
1.23  (.46) .875  (.34) 1.0525  (.4)
[1]
Measure Description: Thickness of the lingual plate measured clinically at the study site
Teeth   [1] 
Measure Type: Number
Unit of measure:  Teeth
Number Analyzed 16 participants 16 participants 32 participants
Maxillary Anteriors 5 5 10
Maxillary Premolars 9 5 14
Mandibular Premolars 2 6 8
[1]
Measure Description: Sites at which immediate implant were placed.
1.Primary Outcome
Title Change in Thickness of Buccal Bone
Hide Description Change of buccal bone volume over study duration
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: millimeters
4mm from free gingival margin (FGM) .73  (.86) .86  (.56)
6mm from free gingival margin (FGM) .63  (.75) .66  (.77)
2.Secondary Outcome
Title Change in Interproximal Bone Levels
Hide Description Change of interproximal marginal bone loss (mean of mesial and distal sites)
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: millimeters
1.38  (.99) 1.42  (.66)
3.Secondary Outcome
Title Pink Esthetic Score
Hide Description Pink 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.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.53  (1.13) 9.88  (2.13)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Control
Hide Arm/Group Description

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.

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

All-Cause Mortality
Test Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Test Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Test Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      0/16 (0.00%)    
Surgical and medical procedures     
Implant Failure *  1/16 (6.25%)  1 0/16 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Hom-Lay Wang
Organization: University of Michigan
Phone: 734-647-6175
Responsible Party: Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
ClinicalTrials.gov Identifier: NCT01628367     History of Changes
Other Study ID Numbers: HUM00050746
First Submitted: June 11, 2012
First Posted: June 26, 2012
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: March 20, 2017