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

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.

Study Overview

• Status: Completed
• Conditions: Ridge Deficiency
• Intervention / Treatment: Procedure: Guided Bone Regeneration (GBR)

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
• Enrollment (Actual): 43
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Ridge Preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks
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	Mean= 19.5 weeks after tooth extraction and bone grafting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ridge Healing Evaluation	Pictures of the healing ridges were taken using clinical macro lens photography	Two weeks form the time of the extraction

Collaborators and Investigators

• Sponsor: Samer Faraj

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 17, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 17, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Guided Bone Regeneration; Ridge Preservation; Dehydrated Human Amnion Chorion Membrane; Type I Bovine Collagen Membrane; Ridge Healing; Teeth Extraction
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: 13-0540-F3R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No