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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study

Conditions
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Ridge Deficiency

Intervention / Treatment
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* Procedure: Guided Bone Regeneration (GBR)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dehydrated Human Amnion Chorion Membrane<br>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)<br>* Teeth Extraction With Bone Grafting and Membrane<br>* Other names: Ridge Preservation;|
| Active Comparator: Type I Bovine Collagen Membrane<br>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)<br>* Teeth Extraction With Bone Grafting and Membrane<br>* Other names: Ridge Preservation;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided Bone Regeneration, Dehydrated Human Amnion Chorion Membrane, Type I Bovine Collagen Membrane, Ridge Preservation, Ridge Healing, Teeth Extraction