Case Series of New Alloplastic Bone Graft Material

NCT ID: NCT02221557

Last Updated: 2017-08-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

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A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.

Detailed Description

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Conditions

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Periodontology Oral Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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New alloplastic bone graft material

Group Type EXPERIMENTAL

easy-graft (beta-Tricalcium Phosphate)

Intervention Type DEVICE

Interventions

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easy-graft (beta-Tricalcium Phosphate)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must have read, understood and signed a consent form.
* 18-75 years of age
* Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.

Exclusion Criteria

* Active caries or endodontic lesions in adjacent teeth
* Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes)
* Taking any medication known for gingival hyperplasia for past 3 months.
* Any systemic contraindications to surgery
* Subject smokes \> 10 cigarettes per day.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunstar Americas

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Maryland School of Dentistry

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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2014-7-1-1

Identifier Type: -

Identifier Source: org_study_id

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