Evaluation of Erythropoietin on Alveolar Ridge Preservation

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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].

Disqualifiers

Smokers

Occlusal trauma at the site of the graft

Pregnancy and lactation

Bad compliance with the plaque control instructions following initial therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • chitosan carrier

    Other intervention

    inert scaffold agent

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: study groupExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions
Group C: positive controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dimensional changes

Clinical measurement using bone caliper. Radiographic measurement using CBCT

Time frame
six months

Secondary outcomes

1

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

Visual analogue scale.

Time frame
six months

Other outcomes

Sponsors and contacts

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