- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367217
Albumin-PRF in Sinus Lift With Implants: 2-Year Study
January 16, 2026 updated by: Ammar Radwan, Mansoura University
Albumin Platelet-Rich Fibrin in Lateral Sinus Floor Augmentation With Simultaneous Implant Placement: A Prospective Two-Year Follow-Up Study
thirty-two 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Al Mansurah, Egypt, 002
- Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: lateral sinus lift with bone augmenation
|
sinus floor elevation with placing allograft and collagen membrane
|
|
Experimental: lateral sinus lift with extended platelet rich fibrin
|
sinus floor elevation with placing extended-PRF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. implant stability
Time Frame: 12 months
|
the stability of the implants will be evaluated by RFA with the Osstell Mentor device.
|
12 months
|
|
2. Vertical bone height
Time Frame: 24 Months
|
vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant
|
24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2023
Primary Completion (Actual)
May 10, 2024
Study Completion (Actual)
November 10, 2025
Study Registration Dates
First Submitted
January 16, 2026
First Submitted That Met QC Criteria
January 16, 2026
First Posted (Actual)
January 26, 2026
Study Record Updates
Last Update Posted (Actual)
January 26, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- R.25.12.93
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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