Menu
Not yet recruiting NCT06601400

Xenograft with or Without Erythropoietin in Immediate Dental Implant

No phase Interventional Hopeless Teeth

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: Erythropoietin (EPO) with xenograft, Xenograft alone.
Who it may be relevant to
Registry conditions: Hopeless Teeth. Basic parameters: from 18 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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Buccal bone thickness. [Time frame: 1 year follow up period]
Secondary outcome measures (7)
  • Crestal bone loss [Time frame: 1 year follow up period]
  • Soft tissue thickness. [Time frame: 1 year follow up period]
  • The pink esthetic score (PES) [Time frame: 1 year follow up period]
  • Success and survival criteria [Time frame: 1 year follow up period]
  • Bleeding on probing (BOP) [Time frame: 1 year follow up period]
  • Pain score [Time frame: 1, 3, and 7 days]
  • Full-mouth plaque score [Time frame: 1 year follow up period]

Eligibility criteria

  • 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.

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
  • Faculty of dentistry, Cairo university — Giza

Publications

  • Fettouh AIA, Ghallab NA, Ghaffar KA, Mina NA, Abdelmalak MS, Abdelrahman AAG, Shemais NM. Bone dimensional changes after flapless immediate implant placement with and without bone grafting: Randomized clinical trial. Clin Implant Dent Relat Res. 2023 Apr;25(2):271-283. doi: 10.1111/cid.13178. Epub 2023 Jan 3. PMID 36596471

Identifiers

NCT: NCT06601400 · Erythropoietin,Dental implant

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗