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

Primary Purpose

Atrophied Posterior Maxillary Ridge

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophied Posterior Maxillary Ridge focused on measuring simultaneous implantation, Dental implant, Open sinus Lifting, PRF, platelet rich fibrin (PRF)

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of oral and dental medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group ( Hydroxyappetite)

Test group (PRF)

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

The amount of new bone formation the sinus cavity using CBCT
the amount of new bone formation of PRF in comparison with Nano-crystalline hydroxyappetite in millimeters using cone beam computed tomography (CBCT)

Secondary Outcome Measures

Full Information

First Posted
October 13, 2015
Last Updated
October 14, 2015
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02577289
Brief Title
Open Sinus Lift Technique With Simultaneous Implantation Using Platelet Rich Fibrin (PRF) Versus Nano-crystalline Hydroxyapatite
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophied Posterior Maxillary Ridge
Keywords
simultaneous implantation, Dental implant, Open sinus Lifting, PRF, platelet rich fibrin (PRF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group ( Hydroxyappetite)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Test group (PRF)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)
Intervention Description
• The sinus cavity will be augmented with bone graft ( Nano crystalline hydroxyapatite)
Intervention Type
Procedure
Intervention Name(s)
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)
Intervention Description
platelet rich fibrin (PRF) as sole grafting material in created space (PRF)
Primary Outcome Measure Information:
Title
The amount of new bone formation the sinus cavity using CBCT
Description
the amount of new bone formation of PRF in comparison with Nano-crystalline hydroxyappetite in millimeters using cone beam computed tomography (CBCT)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed M. Nour El Din, BDS
Phone
+2-01001448723
Email
waleed_nour@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hesham Abdel Hakm, Professor
Phone
+2-01156096060
Email
surgery@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of oral and dental medicine
City
Cairo
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
waleed M. Nour El din, BDS
Phone
+2-01001448723
Email
waleed_nour@live.com
First Name & Middle Initial & Last Name & Degree
Hesham Abdel Hakm, Profeesor
Phone
+2-01156096060
Email
surgery@dentistry.cu.edu.eg

12. IPD Sharing Statement

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

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