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Not yet recruitingNCT06626776Updated Oct 4, 2024

The Use of Extended Platelet Rich Fibrin in Lateral Sinus Augmentation

An interventional study of lateral sinus lift with using allograft and collagen membrane and lateral sinus lift with using exteneded platelet rich fibrin in Sinus Lift Augmentation, sponsored by Mansoura University. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

  1. Clinical Evaluation

    • Implant stability
  2. Radiographic Evaluation Vertical bone gain (VBG)
02

Conditions studied

  • Sinus Lift Augmentation
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patent ostium of maxillary sinus.
  • Patient with missing one or more posterior maxillary teeth.
  • Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
  • A ridge width at the site of implantation of \<5mm.
  • Platelets of normal range.
  • Good oral hygiene.
  • Patients in the age frame between 20 years and 60 years old.
  • No gender preface in selection of the patients.
  • A minimum crown height space of 8 mm.

Exclusion criteria

Exclusion Criteria:

  • Active sinusitis, cyst, tumors or root tips at the planned surgical site.
  • Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
  • Heavy smoking and alcoholism.
  • Parafunctional habits such as bruxism and clenching.
  • Signs of acute infection or pus discharge.
  • Disturbed occlusion.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    lateral sinus lift with bone augmenation

    Procedure: lateral sinus lift with using allograft and collagen membrane

  • Experimental
    lateral sinus lift with extended platelet rich fibrin

    Procedure: lateral sinus lift with using exteneded platelet rich fibrin

Interventions

  • Procedurelateral sinus lift with using allograft and collagen membrane

    sinus floor elevation with placing allograft and collagen membrane

  • Procedurelateral sinus lift with using exteneded platelet rich fibrin

    sinus floor elevation with placing eprf

06

What researchers measure

Primary outcomes

  1. implant stability

    the stability of the implants will be evaluated by RFA with the Osstell Mentor device.

    Time frame: 9 months

  2. Vertical bone height

    vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant

    Time frame: 6 months

07

Study locations

1 site
  • MANSOURA University
    Mansoura, Egypt
    • mansoura · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06626776
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Oct 4, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Oct 4, 2024

Study contacts

ammar samman
Contact
dr.3mmar@std.mans.edu.eg
+201558990325

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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