Erythropoietin - Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement

NCT07150858 — Not applicable, Recruiting, 20 participants, Alexandria University

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Comparison Between Erythropoietin-enhanced Albumin Platelet-rich Fibrin and Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement

Registry	NCT07150858
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Alexandria University (Other)
Conditions	Sinus Lifting
Interventions	Erythropoietin and albumin PRF gel + implant placement, Albumin PRF gel +implant placement (Other)
Dates	start 2025-05-25, primary completion 2026-07-25 (estimated), completion 2026-07-25 (estimated), first posted 2025-09-02, last updated 2025-09-02
Locations	1 site in Egypt

-Summary

Background: 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 trans crestal sinus lifting with albumin platelet rich plasma.

Aim of the study: To compare between erythropoietin and albumin platelet rich fibrin transcrestal sinus lifting versus albumin platelet rich fibrin transcrestal sinus lifting using piezoelectric device in patients with atrophic maxilla.

Methods: This study will be carried out as a randomized

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+Arms and interventions

Arm	Type	Interventions	Description
Erythropoietin and albumin PRF gel	Experimental	Other: Erythropoietin and albumin PRF gel + implant placement
albumin PRF gel	Active comparator	Other: Albumin PRF gel +implant placement

Erythropoietin and albumin PRF gel + implant placement (Other): This group will be treated by transcrestal sinus lifting with erythropoietin and albumin PRF gel with simultaneous implant placement.
Albumin PRF gel +implant placement (Other): This group (the Control group) will be treated with transcrestal sinus lifting using albumin PRF gel, with simultaneous implant placement.

+Outcome measures

Primary outcomes

Change in pain scores [up to 14 days]: pain will be assessed through a 10 point visual analogue scale (VAS). (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe).
Change in edema [up to 14 days]: Edema will be assessed as follows: 1. None (no swelling) 2. Mild (intraoral swelling confined to the surgical field) 3. Moderate (extra oral swelling in the surgical zone) 4. Severe (extraoral swelling spreading beyond the surgical zone)
Change in implant stability [immediate and 4 months]: implant stability will be assessed using ostell device

Secondary outcomes

Change in bone gain [baseline and 4 months]: amount of sinus bone gain (SBG) which equals implant protrusion length (IPL) added to Peri-implant sinus bone level (PSBL) which is the distance between the apex of the implant and sinus bone level
Change in bone density [baseline and 4 months]: it will be assessed using CBCT

+Eligibility

Sex: All, ages: 20 Years to 60 Years

Inclusion Criteria:

* Residual bone height not less than 5 mm measured from crestal bone to sinus floor.
* Both genders.
* Good oral hygiene
* No previous surgery or radiation treatment on the maxillary sinus

Exclusion Criteria:

* Recent radiation therapy in maxilla.
* Uncontrolled systemic diseases such as diabetes mellitus.
* Heavy smoker (those who smoke ≥ 25 cigarettes a day).
* Alcohol abuse.
* Patient on anticoagulant drug
* Severe allergic rhinitis.
* Tumor or large cyst in the maxillary sinus.
* Oroantral fistula.
* Presence of acute or chronic sinus pathoses or sinus membrane perforation.(

+Locations (1)

Facility	City	Country	Status
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University	Alexandria	Egypt	Recruiting