NCT07150858

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
May 2025Jul 2026

Study Start

First participant enrolled

May 25, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

August 27, 2025

Last Update Submit

August 27, 2025

Conditions

Sinus Lifting

Keywords

Transcrestal sinus lifting, erythropoitein, albumin PRF, Peizo electric device, Dental implants, CBCT.

Outcome Measures

Primary Outcomes (3)

  • Change in pain scores

    pain will be assessed through a 10 point visual analogue scale (VAS). (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe).

    up to 14 days

  • Change in edema

    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)

    up to 14 days

  • Change in implant stability

    implant stability will be assessed using ostell device

    immediate and 4 months

Secondary Outcomes (2)

  • Change in bone gain

    baseline and 4 months

  • Change in bone density

    baseline and 4 months

Study Arms (2)

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

Interventions

Erythropoietin and albumin PRF gel + implant placementOTHER

This group will be treated by transcrestal sinus lifting with erythropoietin and albumin PRF gel with simultaneous implant placement.

Erythropoietin and albumin PRF gel
Albumin PRF gel +implant placementOTHER

This group (the Control group) will be treated with transcrestal sinus lifting using albumin PRF gel, with simultaneous implant placement.

albumin PRF gel

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.(

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Central Study Contacts

Hassan M Ruzyqat, BDS

CONTACT

01555767730hassanmohammadrziqat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 2, 2025

Study Start

May 25, 2025

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

July 25, 2026

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

EG(1)