Back to resultsComparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (GBR)
Primary Purpose
Ridge Deficiency
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guided Bone Regeneration (GBR)
Sponsored by
About this trial
This is an interventional treatment trial for Ridge Deficiency focused on measuring Guided Bone Regeneration, Dehydrated Human Amnion Chorion Membrane, Type I Bovine Collagen Membrane, Ridge Preservation, Ridge Healing, Teeth Extraction
Eligibility Criteria
Inclusion Criteria: .
Patients included in the study were required:
- Not to be completely edentulous.
- To have at least 1 tooth that could not be saved and for which extraction and delayed implant placement were planned
Exclusion Criteria: Patients were excluded if they :
- Had received radiation therapy
- Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)
- Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart failure, or acute odontogenic infections)
- Were smokers (more than 10 cigarettes per day)
- Were pregnant or breastfeeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dehydrated Human Amnion Chorion Membrane
Type I Bovine Collagen Membrane
Arm Description
This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement.
Outcomes
Primary Outcome Measures
Alveolar Ridge Dimensional Changes
Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.
Alveolar Ridge Bone Vitality
a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses
Secondary Outcome Measures
Ridge Healing Evaluation
Pictures of the healing ridges were taken using clinical macro lens photography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03290638
Brief Title
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration
Acronym
GBR
Official Title
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 3, 2013 (Actual)
Primary Completion Date
October 1, 2016 (Actual)
Study Completion Date
October 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samer Faraj
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
Detailed Description
Forty-three patients requiring extraction of at least one tooth and delayed implant placement were randomly assigned to either an experimental or a control group. For both groups, demineralized freeze-dried bone allograft was used to graft the socket. For the control group, Type I bovine collagen was used as a membrane; for the experimental group, human amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed, and no primary closure was achieved. Patients returned for implant placement after a mean healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times of extraction and implant placement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ridge Deficiency
Keywords
Guided Bone Regeneration, Dehydrated Human Amnion Chorion Membrane, Type I Bovine Collagen Membrane, Ridge Preservation, Ridge Healing, Teeth Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dehydrated Human Amnion Chorion Membrane
Arm Type
Experimental
Arm Description
This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
Arm Title
Type I Bovine Collagen Membrane
Arm Type
Active Comparator
Arm Description
This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement.
Intervention Type
Procedure
Intervention Name(s)
Guided Bone Regeneration (GBR)
Other Intervention Name(s)
Ridge Preservation
Intervention Description
Teeth Extraction With Bone Grafting and Membrane
Primary Outcome Measure Information:
Title
Alveolar Ridge Dimensional Changes
Description
Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.
Time Frame
Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks
Title
Alveolar Ridge Bone Vitality
Description
a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses
Time Frame
Mean= 19.5 weeks after tooth extraction and bone grafting
Secondary Outcome Measure Information:
Title
Ridge Healing Evaluation
Description
Pictures of the healing ridges were taken using clinical macro lens photography
Time Frame
Two weeks form the time of the extraction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: .
Patients included in the study were required:
Not to be completely edentulous.
To have at least 1 tooth that could not be saved and for which extraction and delayed implant placement were planned
Exclusion Criteria: Patients were excluded if they :
Had received radiation therapy
Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)
Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart failure, or acute odontogenic infections)
Were smokers (more than 10 cigarettes per day)
Were pregnant or breastfeeding.
12. IPD Sharing Statement
Learn more about this trial
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration
We'll reach out to this number within 24 hrs