Xenograft with or Without Erythropoietin in Immediate Dental Implant

September 14, 2024 updated by: Kholoud Sobhy Ibrahim Farag El Deeb, Cairo University

Evaluation of Bone Dimensional Changes After Using Xenograft with or Without Erythropoietin Around Immediate Implants in the Esthetic Zone: a Randomized Clinical Trial

The aim of this study is to evaluate changes in buccal bone thickness after immediate implant placement with xenograft mixed with erythropoietin in the anterior maxilla with a thin buccal bone

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PICO:

Population: Patients with non-restorable tooth in anterior maxilla with thin buccal bone (less than 1mm) Intervention: Immediate implant placement with Xenograft mixed with Erythropoietin.

Control: Immediate implant placement with Xenograft alone.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Faculty of Dentistry, Cairo University
        • Contact:
        • Contact:
          • kholoud Sobhy Eldeeb, Master degree holder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • Inclusion criteria

    • Adult (≥18 years) with non-restorable maxillary teeth in the esthetic zone (upper right second premolar to upper left second premolar).
    • Intact with thin labial plate of bone (≤1mm).
    • The recipient site of the implant should be free from any pathological conditions.
    • Patients who are cooperative, motivated and hygiene conscious.
    • Appropriate crown height space to maintain favorable crown : implant ratio

  • Exclusion criteria

    • Systemic conditions/diseases that contraindicate surgery.
    • Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
    • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
    • Patients with periodontal disease.
    • Alcohol or drug abuse.
    • Pregnant and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Test)
Immediate implant placement with Xenograft mixed with Erythropoietin
Combination product: Erythropoietin (EPO) with xenograft
After atraumatic extraction of the non-restorable tooth, Implant will be placed palatal and apical to osteotomy with at least 2mm gap junction between implant and buccal bone which will be grafted with xenograft and erythropoietin.
Active Comparator: Group B (Control)
Immediate implant placement with Xenograft alone
Other: Xenograft alone
After atraumatic extraction of the non-restorable tooth, implant will be placed palatal and apical to osteotomy with at least 2mm gap junction between implant and buccal bone which will be grafted with xenograft alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buccal bone thickness.
Time Frame: 1 year follow up period
by Cone Beam Computed Tomography (CBCT) in mm
1 year follow up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crestal bone loss
Time Frame: 1 year follow up period
will be measured by Cone Beam Computed Tomography (CBCT) in mm
1 year follow up period
Soft tissue thickness.
Time Frame: 1 year follow up period
will be measured by Endodontic spreader with rubber stopper in mm
1 year follow up period
The pink esthetic score (PES)
Time Frame: 1 year follow up period
by taking photographs
1 year follow up period
Success and survival criteria
Time Frame: 1 year follow up period
the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ≧ 5 mm, and without vertical bone loss ≧ 1.5 mm in the first year. The cases will be defined as failure if it can't reach any one of the success criteria
1 year follow up period
Bleeding on probing (BOP)
Time Frame: 1 year follow up period
According to presence (yes) or absence (No) of bleeding on probing
1 year follow up period
Pain score
Time Frame: 1, 3, and 7 days
by using Visual analogue scale from (0-10)
1, 3, and 7 days
Full-mouth plaque score
Time Frame: 1 year follow up period
According to presence (yes) or absence(No) of plaque
1 year follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Noha ghallab, PHD, Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.
  • Study Chair: Manar El Zanaty, PHD, lecturer of periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 14, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 14, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 14, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erythropoietin,Dental implant

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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