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

NCT ID: NCT03290638

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-03

Study Completion Date

2016-10-01

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.

Conditions

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Ridge Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Guided Bone Regeneration (GBR)

Intervention Type PROCEDURE

Teeth Extraction With Bone Grafting and Membrane

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.

Group Type ACTIVE_COMPARATOR

Guided Bone Regeneration (GBR)

Intervention Type PROCEDURE

Teeth Extraction With Bone Grafting and Membrane

Interventions

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Guided Bone Regeneration (GBR)

Teeth Extraction With Bone Grafting and Membrane

Intervention Type PROCEDURE

Other Intervention Names

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Ridge Preservation

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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samer Faraj

OTHER

Sponsor Role lead

Responsible Party

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Samer Faraj

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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13-0540-F3R

Identifier Type: -

Identifier Source: org_study_id