Dimensional Changes of Peri-implant Tissues Following Jumping Gap Grafting Using Erythropoietin Gel Mixed With Xenograft.

Dimensional Changes of Peri-implant Tissues Following Jumping Gap Grafting Using Erythropoietin Gel Mixed With Xenograft. (A Randomized Controlled Clinical Study)

This study will be conducted to compare the effect of Erythropoietin gel mixed with xenograft versus xenograft alone in grafting the jumping gap around immediate implant.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-implant Bone and Soft Tissues
• Intervention / Treatment: Drug: Erythropoetin gel mixed with xenogenic bone graft; Other: Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose)

Detailed Description

The distance between the implant and the defect's surrounding wall is known as the horizontal bone defect (also known as the "Jumping Distance" or "Gap"). By filling the space between the implant and the buccal bone walls of recently extracted sockets, bone grafting material promotes hard tissue repair and reduces marginal bone loss. To increase bone contact to the implant surface and lessen gingival recession brought on by horizontal bone resorption, bone grafting at the gap is advised.

Various methods have been employed to bridge the gap in bone: autograft and allograft-based bone substitutes, which can be utilized separately or in conjunction with other materials like freeze-dried bone, xenograft (like bovine bone), and ceramic-based bone graft alternatives like calcium phosphate, calcium sulphate, and bio-glass. According to a study by Bianchi S, using xenografts improved the osteoconductive qualities of bone regeneration by demonstrating significant cellular activity.

The potential of EPO to enhance bone growth and tissue protection by reducing ischemia and inflammatory responses is one of its non-hematopoietic properties. EPO stimulates the development of mesenchymal stem cells (MSCs) into osteoblasts and participates in the interactions of osteoblasts and osteoclasts to promote bone formation.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed S Ahmed; Phone Number: +20 1211380626; Email: AhmedShakerTaha@dent.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Both genders aged from 20 to 50 years.
2. Systemically free patients as evidenced by Burket's oral health history questionnaire.
3. Patients need the extraction of non-restorable maxillary tooth in esthetic zone and the possibility of immediate placement of implants on the same site with Intact labial plate and interproximal bone levels (socket type 1).
4. Gap space of more than 2 mm between the implant and buccal bone.

Exclusion Criteria:

1. Smokers.
2. Pregnant or lactating females.
3. Acute infection at the implant site
4. Patients under any medication that affects the healing.
5. Vulnerable group of patients (prisoners, handicapped, and decisional impaired individuals).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with EPO gel mixed with xenogenic bone graft; Patients with EPO gel mixed with xenogenic bone graft in the jumping gap of immediate implant.	Drug: Erythropoetin gel mixed with xenogenic bone graft; Patients with EPO gel mixed with xenogenic bone graft in the jumping gap of immediate implant.
Active Comparator: Patients with xenogenic bone graft and gelling agent; Patients with xenogenic bone graft and gelling agent in the jumping gap of immediate implant.	Other: Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose); Patients with xenogenic bone graft and gelling agent in the jumping gap of immediate implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic assessment	Radiographic assessment of alveolar bone width by CBCT	0-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic assessment	Radiographic assessment of alveolar bone height by CBCT	0-6 months
Clinical assessment	Clinical assessment (Soft tissue height and thickness)	0-3-6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): April 12, 2026
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): November 12, 2026

Study Registration Dates

• First Submitted: April 5, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Radiographic assessment of alveolar bone width (0-6 months).; Radiographic assessment of alveolar bone height (0-6 months).; Clinical assessment (Soft tissue height and thickness): (0-3-6 months).
• Additional Relevant MeSH Terms: Carbohydrates; Polysaccharides; Glucans; Cellulose; Methylcellulose; Carboxymethylcellulose Sodium
• Other Study ID Numbers: FDAsu-RecIM022439

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