Open Sinus Lift Technique With Simultaneous Implantation Using Platelet Rich Fibrin (PRF) Versus Nano-crystalline Hydroxyapatite

October 14, 2015 updated by: waleed Mohamed Mohamed Mahmoud nour el din, Cairo University

Evaluation of Bone Quantity in Open Sinus Lift Technique With Simultaneous Implantation Using Platelet Rich Fibrin (PRF) Versus Nano-crystalline Hydroxyapatite as Sole Grafting Material in Patients With Atrophied Posterior Maxillary Ridge

Evaluation of bone quantity in open sinus lift technique with space maintaining using platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline hydroxyapatite with simultaneous placing of implants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Evaluation of bone quantity in open sinus lift technique with simultaneous implantation using platelet rich fibrin (PRF) versus Nano-crystalline Hydroxyapatite as sole grafting material in patients with atrophied posterior maxillary ridge which provides a new modality for treatment of patients with atrophied posterior maxillary ridge with least cost and a much easier way using platelet rich fibrin (PRF) as substitution to bone graft

Study Type

Interventional

Enrollment (Anticipated)

18

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, 11553
        • Recruiting
        • Faculty of Oral and Dental Medicine
        • Contact:
        • Contact:

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients should be seeking for implant supported prosthesis in posterior maxilla bilaterally
  • All patients should have atrophied posterior maxillary ridge with the maximum height of the alveolar bone is from 3 mm to 5 mm

Exclusion Criteria:

  • Ongoing steroid therapy;
  • Uncontrolled diabetes;
  • Recent cardiovascular diseases;
  • Inflammation of the maxillary sinus;
  • Previous radiant therapy for neoplastic pathologies
  • Patient who have had previous failed sinus augmentation, or exhibited pathological finding or had a history of maxillary sinus disease or operations or whose medical condition might increase surgical risk of the research protocol were excluded.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group ( Hydroxyappetite)
Patients will undergo open sinus lift using nano crystalline hydroxyapatite as augmentation material and placing implants simultaneously then evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)
Procedure: Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)
• The sinus cavity will be augmented with bone graft ( Nano crystalline hydroxyapatite)
Experimental: Test group (PRF)
Patients will undergo open sinus lift using PRF as sole augmentation material and placing implants simultaneously then Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)
Procedure: Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)
platelet rich fibrin (PRF) as sole grafting material in created space (PRF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of new bone formation the sinus cavity using CBCT
Time Frame: 6 months
the amount of new bone formation of PRF in comparison with Nano-crystalline hydroxyappetite in millimeters using cone beam computed tomography (CBCT)
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • open_sinus_augmentation

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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