Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone

February 26, 2021 updated by: Ain Shams University

The Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone in Horizontal Alveolar Ridge Augmentation - Controlled Clinical and Histomorphometric Study

Comparing amount of horizontal bone gain 4 months after alveolar ridge augmentation using IPRF Nano- micro Sticky Bone with perforated collagen membrane versus occlusive barrier membrane by :

  1. clinical and Radiographic analysis .
  2. Histomorphometric analysis .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • ain shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adult patients.
  2. Both sex, males and females. 3-Age from 20 - 40 years old. 4-All patients will be free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.

5-Remaining alveolar bone ≥ 8mm vertically and ≤ 4 mm horizontally. 6-Gingival biotype 1-2mm thickness.

Exclusion Criteria:

  1. Smokers.
  2. Pregnant and breast feeding females.
  3. Mentally retarded Patients.
  4. Presence of hematologic disease.
  5. Previous radiation, chemotherapy, or immunosuppressive treatments.
  6. Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
  7. Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Perforated collagen membrane
Procedure: Perforated collagen membrane
Horizontal Bone Augmentation using Perforated Collagen Membrane
ACTIVE_COMPARATOR: Occlusive collagen membrane
Procedure: Occlusive collagen membrane
Occlusive collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal alveolar bone width in mm
Time Frame: 6 months
Measured By Bone caliber and Cone Beam Computed Tomography (CBCT)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (ACTUAL)

March 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • FDASU-Rec ID021701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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