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CompletedNCT05721612Updated Feb 21, 2023

Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach

An interventional study of Flapless transcrestal sinus lift approach with TPRF and Flapless transcrestal sinus lift approach with PRF in Sinus Floor Elevation, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Mar 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study summary

Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence flapless transcrestal sinus floor elevation is minimally invasive technique which is used in moderately defected maxilla.

Aim of the study: to evaluate both clinical and radiographic outcomes in sinus floor elevation following dental implant placement using flapless transcrestal sinus lift approach with Titanium platelet rich fibrin (TPRF) as a sole sinus graft material compared to Platelet rich fibrin (PRF).

02

Conditions studied

  • Sinus Floor Elevation
03

In context

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient seeking replacement of a missed maxillary posterior teeth by a delayed dental implant procedure.
  • Residual bone height is (4-7) mm measured from crestal bone to sinus floor.
  • Good oral hygiene

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled Diabetes.
  • Coagulation disorders.
  • Immunological disorders.
  • Previous radiation of the head and neck region.
  • Abnormal bone physiology.
  • Therapy with Bisphosphonates.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Study group

    Other: Flapless transcrestal sinus lift approach with TPRF

  • Active comparator
    Control gorup

    Other: Flapless transcrestal sinus lift approach with PRF

Interventions

  • OtherFlapless transcrestal sinus lift approach with TPRF

    Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the TPRF as a sole grafting material.

  • OtherFlapless transcrestal sinus lift approach with PRF

    Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the PRF as a sole grafting material.

06

What researchers measure

Primary outcomes

  1. Change in bone density

    Cuts of CBCT (cross sectional, axial and sagittal view), bone density, will be analyzed using On-demand software. The radiographic evaluation will be based on radiological parameters, using reference points and lines at T0 and T1.

    Time frame: Baseline and 6 months

Secondary outcomes

  1. Change in implant stability

    Secondary implant stability will be measured 6 months post-operatively using Osstell device.

    Time frame: Baseline and 6 months

  2. change in pain scores

    Pain (by Visual Analogous Scale) ranges from 0 to 10 0 - No pain. 2 to 4 - Mild pain. 5 to 7 - Moderate pain. 8 to 10 - severe pain.

    Time frame: 1st day, 3rd day and 1 week

07

Study locations

1 site
  • Alexandria Faculty of Dentistry
    Alexandria, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05721612
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted
Feb 10, 2023
Start date
Mar 15, 2022
Primary completion
Jan 30, 2023
Completion
Feb 5, 2023
Last update
Feb 21, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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