NCT06601400

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

September 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 11, 2024

Last Update Submit

September 14, 2024

Conditions

Hopeless Teeth

Keywords

dental implantErythropoietinXenograft

Outcome Measures

Primary Outcomes (1)

  • Buccal bone thickness.

    by Cone Beam Computed Tomography (CBCT) in mm

    1 year follow up period

Secondary Outcomes (7)

  • Crestal bone loss

    1 year follow up period

  • Soft tissue thickness.

    1 year follow up period

  • The pink esthetic score (PES)

    1 year follow up period

  • Success and survival criteria

    1 year follow up period

  • Bleeding on probing (BOP)

    1 year follow up period

  • +2 more secondary outcomes

Study Arms (2)

Group A (Test)

EXPERIMENTAL

Immediate implant placement with Xenograft mixed with Erythropoietin

Combination Product: Erythropoietin (EPO) with xenograft

Group B (Control)

ACTIVE COMPARATOR

Immediate implant placement with Xenograft alone

Other: Xenograft alone

Interventions

Erythropoietin (EPO) with xenograftCOMBINATION_PRODUCT

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.

Group A (Test)
Xenograft aloneOTHER

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.

Group B (Control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo university

Giza, Egypt

Location

Related Publications (1)

  • 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: 36596471BACKGROUND

MeSH Terms

Interventions

ErythropoietinTransplantation, Heterologous

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTransplantationSurgical Procedures, Operative

Study Officials

  • Noha ghallab, PHD

    Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.

    STUDY DIRECTOR

  • Manar El Zanaty, PHD

    lecturer of periodontology

    STUDY CHAIR

Central Study Contacts

kholoud El Deeb, Master degree holder

CONTACT

(+20)1113211914kholoud.eldeeb@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer at future university in egypt

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

September 14, 2024

Primary Completion

October 1, 2025

Study Completion

January 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)