Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602223
Recruitment Status : Completed
First Posted : November 11, 2015
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Collaborator:
Snoasis Medical Products
Information provided by (Responsible Party):
Sivaraman Prakasam, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alveolar Bone Loss
Pathological Conditions, Anatomical
Interventions Device: Placing Amnion chorion membrane over grafted site
Device: Placing d-PTFE membrane over grafted site
Enrollment 9
Recruitment Details Screening, recruitment and study-related procedures were done at Indiana University School of Dentistry (IUSD) clinics between 9/17/2012 and 7/14/2014
Pre-assignment Details  
Arm/Group Title Amnion Chorion Membrane & d-PTFE
Hide Arm/Group Description

Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed.

Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Amnion Chorion Membrane & d-PTFE
Hide Arm/Group Description

Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed.

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  77.8%
>=65 years
2
  22.2%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
54.88
(34 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
3
  33.3%
Male
6
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
Total Number of sites (maxilla vs Mandible)   [1] 
Measure Type: Number
Unit of measure:  Sites
Number Analyzed 9 participants
Total 22
Maxilla 14
Mandible 8
[1]
Measure Description: Number of sites in maxilla that received either ACM or d-PTFE
Number of participants with multiple study sites   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
Single paired study sites 7
Multiple (two) paired study sites 2
[1]
Measure Description: Number of participants who received either single vs multiple bilateral sites
1.Primary Outcome
Title Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures
Hide Description A radiographic stent will be fabricated with reproducible access holes ≈5 mm apical to the mid-facial and mid-lingual gingival margin of the teeth to be extracted. On day of surgery, a calibrated examiner masked to treatment allocation, will record initial clinical bucco-lingual (iCBL) ridge measurements in millimeters (mm), through the access holes in the stent, using calipers. Approximately 3.5(±0.5)-months post extractions, the calibrated examiner masked to treatment allocation, will record the final clinical bucco-lingual (fCBL) ridge measurements in mm using the calipers as described earlier. The difference between fCBL and iCBL will be calculated as change in clinical horizontal ridge width dimensions in mm (cΔHD).
Time Frame 3-4 months
Hide Outcome Measure Data
Hide Analysis Population Description
change in clinical horizontal ridge width dimensions in mm - cΔHD
Arm/Group Title Amnion Chorion Membrane d-PTFE Membrane
Hide Arm/Group Description:

Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side

Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

Overall Number of Participants Analyzed 9 9
Overall Number of Units Analyzed
Type of Units Analyzed: Sites
11 11
Mean (Standard Deviation)
Unit of Measure: millimeters
2.54  (1.29) 2.72  (1.01)
2.Primary Outcome
Title Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages.
Hide Description Approximately 3-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. A high-resolution microtomographic scanner will be used and images will be scanned at a voxel size of 8µm3. Moist bone cores will be wrapped in paraffin and scanned in air. Cores will be rotated in 0.7 degree increments with 450milli second time exposition. A 0.5m aluminum filter will be used to remove image noise. After scanning, 3D microstructural image data will be reconstructed using software. Structural indices will be calculated using a software. The micro-architectural variables; bone volume density (BV/TV), and bone surface density (BS/BV); will be quantified and reported as percentages.
Time Frame 3-4 month
Hide Outcome Measure Data
Hide Analysis Population Description
The micro-architectural variable; bone volume density (BV/TV),was quantified and is reported as percentages.
Arm/Group Title Amnion Chorion Membrane d-PTFE Membrane
Hide Arm/Group Description:

Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side

Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: Percentage of BV/TV
51.74  (17.13) 37.31  (11.93)
3.Primary Outcome
Title Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages.
Hide Description Approximately 3.5(±0.5)-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. Cores will be process and embedded in polymethylmethacrylate and sectioned to 5μm thickness and sections will be stained with Goldener's Trichrome. With the Goldener's trichrome, mineralized bone appears as green or blue regions, osteoid appears orange-red, nuclei appears blue-grey and graft remnants appear grey. Additional differentiation between graft and new bone will be achieved by morphologically assessing each sample individually. A slide scanner will be used to image the sample (20x magnification), and a software program will be used for the histomorphometric analysis, to quantify the amount of total mineralized bone, new bone / osteoid, soft tissue, and residual graft remnants in percentages .
Time Frame 3-4 months
Hide Outcome Measure Data
Hide Analysis Population Description
New bone/osteoid Percentages
Arm/Group Title Amnion Chorion Membrane d-PTFE Membrane
Hide Arm/Group Description:

Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side

Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: Percentage of New bone
8.31  (8.20) 3.50  (3.59)
4.Primary Outcome
Title Post Operative Pain
Hide Description A visual Analog score (VAS) pain scale form (scale of 1 to 10) will be provided with instructions to record pain levels on both surgical sites every day for 2-weeks post-surgery. VAS score of 10 indicates highest level of pain and 0 indicates no pain. Subjects will also asked to log any pain medications taken in that 2-week period. Subjects will be seen at 1&2 weeks for post-operative evaluation and VAS forms will be collected. Data will be reported as Average VAS score.
Time Frame 0-2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
VAS score at 24 hours post operative
Arm/Group Title Amnion Chorion Membrane d-PTFE Membrane
Hide Arm/Group Description:

Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side

Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: Units on a scale of 10
1.82  (1.57) 4.09  (2.7)
5.Primary Outcome
Title Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Horizontal Ridge Width Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.
Hide Description Radiographic stent with radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. The initial relative crest (iRC) reference point will be determined. The buccal and lingual crests at the central plane of site will be marked and distances from this crest to RRP will be measured in mm. The average distance of the buccal crest height and the lingual crest height will be calculated and that value will be used to determine the iRC for that site. Initial Bucco-lingual (iRBL) measurements will be recorded at 1 mm, 3 mm and 7 mm from iRC in all five planes. The final bucco-lingual (fRBL) measurements will be recorded on the second CBCT, using the same method as described before and using the iRC reference. Differences between iRBL and the fRBL reflect change in horizontal ridge width (RΔHD).
Time Frame 3-4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Change in horizontal ridge width (RΔHD).
Arm/Group Title Amnion Chorion Membrane d-PTFE Membrane
Hide Arm/Group Description:

Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side

Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: millimeters
1.33  (0.72) 2.53  (3.34)
6.Primary Outcome
Title Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Vertical Ridge Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.
Hide Description Radiographic stent with a radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3.5(±0.5)-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. Initial relative crest iRC will be determined as described above from the initial CBCT. In the second CBCT, vertical distance from the iRC from initial CBCT will be used to recreate the iRC. New relative crest will be determined for each of the three planes (nRC) as above. The difference between iRC and nRC indicates change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.
Time Frame 3-4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.
Arm/Group Title Amnion Chorion Membrane d-PTFE Membrane
Hide Arm/Group Description:

Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side

Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: millimeters
-0.24  (0.91) 1.18  (2.22)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amnion Chorion Membrane d-PTFE Membrane
Hide Arm/Group Description

Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.

Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side

Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed

All-Cause Mortality
Amnion Chorion Membrane d-PTFE Membrane
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Amnion Chorion Membrane d-PTFE Membrane
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amnion Chorion Membrane d-PTFE Membrane
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Small Sample size, but expanding study not justified through post hoc analysis. Crossover effects due to split mouth study design potentially indirect and possibly only minimal due to biological infeasibility of cross over effects.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sivaraman Prakasam
Organization: Oregon Health & Sciences University
Phone: 503-346-4711
EMail: prakasam@ohsu.edu
Layout table for additonal information
Responsible Party: Sivaraman Prakasam, Indiana University
ClinicalTrials.gov Identifier: NCT02602223    
Other Study ID Numbers: 1207009182
First Submitted: November 8, 2015
First Posted: November 11, 2015
Results First Submitted: April 15, 2016
Results First Posted: October 7, 2016
Last Update Posted: October 7, 2016