Erythropoietin Gel Effect on Dental Implant Stability

Evaluation of Erythropoietin Gel Effect on Stability of Immediate Implant ( Clinical and Radiographical Study )

• Achieving and maintaining long-term osseointegration for dental implants is a key objective in the field of dentistry. The success of osseointegration is influenced by the surface treatment applied to dental implants. Numerous coating techniques have been developed to improve and speed up osseointegration.
• The aim of the current study is to assess immediate dental implant stability coated with erythropoietin gel, both clinically and radiographically.
• Materials and Methods: We conducted a randomized controlled clinical trial.The sample will include patients demanding immediate implant treatment in the anterior maxilla . Patients will be randomly allocated into the two groups of the study. The group A will be treated with erythropoietin gel coated dental implant immediately after extraction of non restorable teeth in the anterior maxilla . Group B will be treated with non coated dental implant immediately after extraction of non restorable teeth in the anterior maxilla .
• The primary outcome variable will be implant stability and the secondary outcome will be crestal marginal bone level and bone density around implants. It will be measured at time of implant placement and reevaluated after 6-months .

Study Overview

• Status: Recruiting
• Conditions: Osseointegration
• Intervention / Treatment: Other: Erythropoietin gel coated implants; Other: Non coated dental implants

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mohsen Principle investigator; Phone Number: 00201020994802; Email: a7medmohsen453@gmail.com
• Study Contact Backup: Name: Mohamed Mahjob Head of oral and maxillofacial surgery department; Phone Number: 00201001544056

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 088
      • Recruiting
      • Faculty of dental medicine Al-Azhar university
      • Contact: Mohamed Mahjob Head of oral and maxillofacial surgery department; Phone Number: 00201001544056
      • Contact: Mohamed Alaa Lecturer of OMFS; Phone Number: 00201091919870
      • Principal Investigator: Ahmed Mohsen Principle investigator
      • Principal Investigator: Mohamed Mahjob Head of oral and maxillofacial surgery department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients Should have nonrestorable teeth in the anterior maxilla indicated for extraction and seeking implant placement.
• Good general periodontal health and maintenance.

Exclusion Criteria:

• Heavy smokers who smoke more than ten cigarettes per day
• Acute infected socket
• Ant socket with wall defect.
• Pregnency
• Local or systemic conditions that will interfere with bone healing (uncontrolled diabetes mellitus or human immune deficiency virus infections, resonance therapy), bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease.
• Patients who had subjected to intravenous and/or oral bisphosphonate therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Patients with fresh extraction sockets in the anterior maxilla will be treated by immediate implant coated by erythropoietin gel .	Other: Erythropoietin gel coated implants; Patients with fresh extraction sockets in the anterior maxilla will be treated by immediate implant coated by erythropoietin gel.
Active Comparator: Control group; Patients with fresh extraction sockets in the anterior maxilla will be treated by non coated immediate implant .	Other: Non coated dental implants; Patients with fresh extraction sockets in the anterior maxilla will be treated by non coated immediate implant .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in implant stability	Implant stability will be assessed by using ( AnyCheck - Implant Stability Tester ) Utilizes physical tapping technique and dumping capacity analysis to measure implant stability with precision	Baseline and after 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in marginal bone level and bone density around implants	To evaluate the amount of marginal bone loss and bone density around osseointegrated implants, all patient will be subjected to Cone beam computed tomography (CBCT) immediate postoperative and after 6 months.	Baseline and after 6 month

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Mohamed Alaa Lecturer of OMFS, Faculty of dental medicine Al-Azhar university

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: Implant surface modification

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No