GBR With Ptfe With Bovine Bone With and Without Autogenous

NCT ID: NCT03628157

Last Updated: 2018-08-14

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-08-31

Brief Summary

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Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.

CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.

Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio

* 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.
* 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.

Detailed Description

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Conditions

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Atrophied Anterior Maxillary Ridges

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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intervention

using a bio-oss bovine bone alone

Group Type EXPERIMENTAL

Geistlich Bio-Oss® bovine bone alone

Intervention Type OTHER

Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone

control

using a bio-oss bovine bone with autogenous bone ratio 1:1

Group Type ACTIVE_COMPARATOR

Geistlich Bio-Oss® bovine bone alone

Intervention Type OTHER

Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone

Interventions

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Geistlich Bio-Oss® bovine bone alone

Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • Patients with atrophied anterior maxillary ridge area.

* Age: 18 years and older.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate bone augmentation

Exclusion Criteria

* • Heavy smokers more than 20 cigarettes per day.(32)

* Patients with systemic disease that may affect normal healing.
* Psychiatric problems.
* Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
* Pregnant or nursing women.
* Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
* Patient with previous history of radiotherapy.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sherif osama hegazy

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Oral and Dental Medicine

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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sherif hegazy, bachelor

Role: CONTACT

00201008183867

Facility Contacts

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hassan A ahmed, bachelor

Role: primary

(+202) 23642938

Other Identifiers

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Bone augmentation

Identifier Type: -

Identifier Source: org_study_id

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