NCT05134753

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

November 15, 2021

Last Update Submit

December 12, 2021

Conditions

Maxillary Sinus

Keywords

PRFAdvanced PRFSinus augmentation

Outcome Measures

Primary Outcomes (1)

  • Bone quality

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

    Six months

Secondary Outcomes (1)

  • Bone quantity

    Six months

Study Arms (2)

Study arm

EXPERIMENTAL

Patients will undergo sinus augmentation with advanced PRF

Biological: Advanced PRF

Controlled arm

PLACEBO COMPARATOR

Patients will undergo sinus augmentation with PRF

Biological: Control

Interventions

Advanced PRFBIOLOGICAL

Advanced PRF will be placed for patients undergoing sinus augmentation

Study arm
ControlBIOLOGICAL

PRF will be placed for patients undergoing sinus augmentation

Controlled arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The Patients with missing posterior maxillary teeth with insufficient available bone for implant placement indicating the need for maxillary sinus floor augmentation before implantation.
  • \. The Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
  • \. The Patients should be free from any sinus disease that might affect the health and integrity of the sinus lining.
  • \. Assign an informed consent to be involved in the study.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mahinour Magdy Mohamed

CONTACT

01223944859Mahinour_mohamed@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident oral surgery

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 26, 2021

Study Start

January 30, 2022

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

December 23, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share