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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

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.

Condition or disease Intervention/treatment Phase
Ridge Deficiency Procedure: Guided Bone Regeneration (GBR) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 3, 2013
Actual Primary Completion Date : October 1, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration
Drug Information available for: Collagen

Arm Intervention/treatment
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.
Procedure: Guided Bone Regeneration (GBR)
Teeth Extraction With Bone Grafting and Membrane
Other Name: Ridge Preservation

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.
Procedure: Guided Bone Regeneration (GBR)
Teeth Extraction With Bone Grafting and Membrane
Other Name: Ridge Preservation




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Responsible Party: Samer Faraj, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03290638     History of Changes
Other Study ID Numbers: 13-0540-F3R
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samer Faraj, University of Kentucky:
Guided Bone Regeneration
Dehydrated Human Amnion Chorion Membrane
Type I Bovine Collagen Membrane
Ridge Preservation
Ridge Healing
Teeth Extraction

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes