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Not yet recruiting NCT07523412

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

Phase IV Interventional Peri-implant Bone and Soft Tissues

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erythropoetin gel mixed with xenogenic bone graft, Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose).
Who it may be relevant to
Registry conditions: Peri-implant Bone and Soft Tissues. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Drug Erythropoetin gel mixed with xenogenic bone graft
    Patients with EPO gel mixed with xenogenic bone graft 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.

Primary outcome measures

  • Radiographic assessment [Time frame: 0-6 months]
Secondary outcome measures (2)
  • Radiographic assessment [Time frame: 0-6 months]
  • Clinical assessment [Time frame: 0-3-6 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ahmed — Cairo

Identifiers

NCT: NCT07523412 · FDAsu-RecIM022439

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗