NCT06665451

Brief Summary

  • 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 .

Trial Health

77
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 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

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Study Timeline

Key milestones and dates

Study Progress97%
Mar 2025Jul 2026

First Submitted

Initial submission to the registry

October 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

October 25, 2024

Last Update Submit

May 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in marginal bone level and bone density around implants

    Baseline and after 6 month

Study Arms (2)

Test Group

EXPERIMENTAL

Patients with fresh extraction sockets in the anterior maxilla will be treated by immediate implant coated by erythropoietin gel .

Control group

ACTIVE COMPARATOR

Patients with fresh extraction sockets in the anterior maxilla will be treated by non coated immediate implant .

Other: Non coated dental implants

Interventions

Patients with fresh extraction sockets in the anterior maxilla will be treated by non coated immediate implant .

Control group

Patients with fresh extraction sockets in the anterior maxilla will be treated by immediate implant coated by erythropoietin gel.

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dental medicine Al-Azhar university

Asyut, Asyut Governorate, 088, Egypt

RECRUITING

Study Officials

  • Mohamed Alaa Lecturer of OMFS

    faculty of Dental medicine Al-Azhar University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Mohsen Principle investigator

CONTACT

Mohamed Mahjob Head of oral and maxillofacial surgery department

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 25, 2024

First Posted

October 30, 2024

Study Start

March 15, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations