Xenograft with or Without Erythropoietin in Immediate Dental Implant

NCT ID: NCT06601400

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-14

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Hopeless Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A (Test)

Immediate implant placement with Xenograft mixed with Erythropoietin

Group Type EXPERIMENTAL

Erythropoietin (EPO) with xenograft

Intervention Type COMBINATION_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 B (Control)

Immediate implant placement with Xenograft alone

Group Type ACTIVE_COMPARATOR

Xenograft alone

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Kholoud Sobhy Ibrahim Farag El Deeb

assistant lecturer at future university in egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha ghallab, PHD

Role: STUDY_DIRECTOR

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

Manar El Zanaty, PHD

Role: STUDY_CHAIR

lecturer of periodontology

Locations

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Faculty of dentistry, Cairo university

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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kholoud El Deeb, Master degree holder

Role: CONTACT

(+20)1113211914

Facility Contacts

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Cairo University

Role: primary

(+202)23634965

kholoud Sobhy Eldeeb, Master degree holder

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 36596471 (View on PubMed)

Other Identifiers

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Erythropoietin,Dental implant

Identifier Type: -

Identifier Source: org_study_id

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