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Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (GBR)

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ClinicalTrials.gov Identifier: NCT03290638
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Samer Faraj, University of Kentucky

September 6, 2017
September 25, 2017
September 25, 2017
October 3, 2013
October 1, 2016   (Final data collection date for primary outcome measure)
  • Alveolar Ridge Dimensional Changes [ Time Frame: Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks ]
    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 [ Time Frame: Mean= 19.5 weeks after tooth extraction and bone grafting ]
    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
Same as current
No Changes Posted
Ridge Healing Evaluation [ Time Frame: Two weeks form the time of the extraction ]
Pictures of the healing ridges were taken using clinical macro lens photography
Same as current
Not Provided
Not Provided
 
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ridge Deficiency
Procedure: Guided Bone Regeneration (GBR)
Teeth Extraction With Bone Grafting and Membrane
Other Name: Ridge Preservation
  • Experimental: Dehydrated Human Amnion Chorion Membrane
    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.
    Intervention: Procedure: Guided Bone Regeneration (GBR)
  • Active Comparator: Type I Bovine Collagen Membrane
    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: Procedure: Guided Bone Regeneration (GBR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
Same as current
October 1, 2016
October 1, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 78 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03290638
13-0540-F3R
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Samer Faraj, University of Kentucky
Samer Faraj
Not Provided
Not Provided
University of Kentucky
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP