PRF Versus Advanced PRF in Sinus Augmentation

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05134753
Collaborator
(none)
32
2
7

Study Details

Study Description

Brief Summary

In the present study the main hypothesis , Advanced PRF will improve the bone quality and quantity in sinus augmentation

Condition or Disease Intervention/Treatment Phase
  • Biological: Advanced PRF
  • Biological: Control
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Platelet Rich Fibrin Versus Advanced Platelet Rich Fibrin as Bone Graft Material in Sinus Augmentation (Randomized Controlled Clinical Trial)
Anticipated Study Start Date :
Jan 30, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study arm

Patients will undergo sinus augmentation with advanced PRF

Biological: Advanced PRF
Advanced PRF will be placed for patients undergoing sinus augmentation

Placebo Comparator: Controlled arm

Patients will undergo sinus augmentation with PRF

Biological: Control
PRF will be placed for patients undergoing sinus augmentation

Outcome Measures

Primary Outcome Measures

  1. Bone quality [Six months]

    Histological analysis for core biopsies Available bone quality will be evaluated by measuring the Total Bone Volume (TBV)

Secondary Outcome Measures

  1. Bone quantity [Six months]

    • Linear height measurements changes of the bone will be evaluated via panoramic X-rays

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The Patients with missing posterior maxillary teeth with insufficient available bone for implant placement indicating the need for maxillary sinus floor augmentation before implantation.
  1. The Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

  2. The Patients should be free from any sinus disease that might affect the health and integrity of the sinus lining.

  3. Assign an informed consent to be involved in the study.

Exclusion Criteria:

Patients with any systemic disease that may affect normal healing. 2. Patients with any sinus disease.

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahinour magdy mohamed, Resident oral surgery, Cairo University
ClinicalTrials.gov Identifier:
NCT05134753
Other Study ID Numbers:
  • PRF and sinus augmentation
First Posted:
Nov 26, 2021
Last Update Posted:
Dec 23, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mahinour magdy mohamed, Resident oral surgery, Cairo University

Study Results

No Results Posted as of Dec 23, 2021