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NCT Number: NCT07150858

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

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

Recruiting

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Key information

Conditions

Sinus Lifting

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location status: Recruiting

Location contact

Hassan M Ruzyqat, BDS

CONTACT

[email protected]

01555767730

Hassan M Ruzyqat, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.(

Treatment and study plan

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.

Primary outcomes

  1. Change in pain scores

    Time frame: 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).

  2. Change in edema

    Time frame: up to 14 days

    Edema will be assessed as follows:

    • None (no swelling)
    • Mild (intraoral swelling confined to the surgical field)
    • Moderate (extra oral swelling in the surgical zone)
    • Severe (extraoral swelling spreading beyond the surgical zone)

  3. Change in implant stability

    Time frame: immediate and 4 months

    implant stability will be assessed using ostell device

Secondary outcomes

  1. Change in bone gain

    Time frame: 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

  2. Change in bone density

    Time frame: baseline and 4 months

    it will be assessed using CBCT

Study contacts

Contact information is provided by the study sponsor or research team.

Hassan M Ruzyqat, BDS

CONTACT

[email protected]

01555767730

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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