Evaluation of Erythropoietin on Alveolar Ridge Preservation

NCT06513039 | Recruiting Phase 4

• 1 other identifier: 1111 phd
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

regenerative materials would help in decreasing post-extraction resorption in sites indicated for placement of a conventional bridge or prosthetically driven implant. Erythropoietin (EPO) is a growth factor that promotes angiogenesis and bone regeneration by stimulating osteoblastic differentiation and by inhibiting osteoclastic resorption. Post-extraction alveolar ridge resorption creates morphological and volumetric changes. These changes can be considered of clinical value that may threaten the placement of a conventional bridge or an implant-supported crown. Atwood et al. \[1\] in a cephalometric study categorized factors influencing the rate of alveolar ridge resorption into 4 types: anatomic, metabolic, functional, and prosthetic. As stated by Tan et al. \[2\] in a systematic review of alveolar hard and soft tissue dimensional changes in humans post-extraction, they found that alveolar ridge resorption occurs to a greater extent in a horizontal direction than vertical. Therefore, alveolar ridge preservation (ARP) procedures were introduced in an attempt to prevent hard and soft tissue dimensional changes following extraction.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Dimensional changes

  Clinical measurement using bone caliper. Radiographic measurement using CBCT

  six months

Secondary Outcomes (1)

• Postoperative Pain level Postoperative wound Healing Patterns of bone regeneration of extraction socket

  six months

Study Arms (3)

study group

EXPERIMENTAL

Patient will have extraction of teeth and placement of Erythropoietin carried on chitosan carrier for six months

Drug: Erythropoietin carried on chitosan carrier

control

NO INTERVENTION

Patient will have extraction of teeth only and followup

positive control

ACTIVE COMPARATOR

Patient will have extraction of teeth and placement of chitosan carrier only for six months

Other: chitosan carrier

Interventions

Erythropoietin carried on chitosan carrier DRUG

Patient will have extraction of teeth and placement of Erythropoietin carried on chitosan carrier for six months to enhance bone healing

study group

chitosan carrier OTHER

inert scaffold agent

positive control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range (18-40).
• Hopeless teeth indicated for extraction such as root fractures, caries, internal root resorption, external root resorption, endodontic failures.
• Systemically free patients using Cornell Medical Index-Health Questionnaire \[36\].
• Patients diagnosed with intact surrounding alveolar bone (socket type I) \[37\].
• Maxillary anterior teeth and/or premolars indicated for extraction.
• Enough zone of keratinized tissue (≥2 mm).

You may not qualify if:

• Smokers
• Occlusal trauma at the site of the graft
• Pregnancy and lactation
• Bad compliance with the plaque control instructions following initial therapy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

RECRUITING

Related Publications (1)

• Atwood DA. Some clinical factors related to rate of resorption of residual ridges. 1962. J Prosthet Dent. 2001 Aug;86(2):119-25. doi: 10.1067/mpr.2001.117609. No abstract available.

  PMID: 11514795 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Marwa El Kassaby

CONTACT

01001741212; marwaelkassaby@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Three group randomized clinical trial study

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 22, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

EG (1)