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NCT Number: NCT07523412

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders aged from 20 to 50 years.
  • Systemically free patients as evidenced by Burket's oral health history questionnaire.
  • 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).
  • Gap space of more than 2 mm between the implant and buccal bone.

Exclusion criteria

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

Treatment and study plan

Erythropoetin gel mixed with xenogenic bone graft

Drug

Patients with EPO gel mixed with xenogenic bone graft in the jumping gap of immediate implant.

Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose)

Other

Patients with xenogenic bone graft and gelling agent in the jumping gap of immediate implant.

Primary outcomes

  1. Radiographic assessment

    Time frame: 0-6 months

    Radiographic assessment of alveolar bone width by CBCT

Secondary outcomes

  1. Radiographic assessment

    Time frame: 0-6 months

    Radiographic assessment of alveolar bone height by CBCT

  2. Clinical assessment

    Time frame: 0-3-6 months

    Clinical assessment (Soft tissue height and thickness)

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed S Ahmed

CONTACT

[email protected]

+20 1211380626

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.