Actively Recruiting

Phase 4
Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID06513039

Evaluation of Erythropoietin on Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial with Histomorphometric Assessment

Led by Ain Shams University · Updated on 2024-07-22

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of erythropoietin (EPO), a growth factor that promotes blood vessel formation and bone regeneration, to reduce bone loss after tooth extraction in areas planned for bridges or dental implants. The study focuses on preserving the alveolar ridge—the bone surrounding the tooth socket—which often shrinks, affecting implant placement. This randomized controlled trial aims to measure how EPO affects bone size changes and healing after extraction. Participants are divided into three groups: one receiving tooth extraction followed by placement of EPO on a chitosan carrier in the socket; another receiving extraction with chitosan carrier alone; and a control group with natural healing after extraction. The surgical procedure includes careful tooth extraction, socket preparation, and suturing. Follow-up includes implant placement after four months, with bone biopsies collected for detailed bone analysis. Participants will have clinical assessments of bone dimension changes immediately after extraction and at four months using calipers and cone beam CT scans. Postoperative pain and wound healing will be evaluated with patient reports and healing indexes. Bone regeneration patterns will be studied through histological examination of biopsies. The study duration includes initial treatment, four months follow-up, and assessments of bone changes and healing over six months.

CONDITIONS

Brief Title

Evaluation of Erythropoietin on Alveolar Ridge Preservation

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 40 years
  • Teeth indicated for extraction due to root fractures, caries, internal or external root resorption, or endodontic failure
  • Generally healthy patients as confirmed by health questionnaire
  • Presence of intact surrounding alveolar bone (socket type I)
  • Maxillary anterior teeth or premolars indicated for extraction
  • At least 2 mm of keratinized gum tissue around the extraction site
Not Eligible

You will not qualify if you...

  • Smokers
  • Occlusal trauma at the graft site
  • Pregnant or breastfeeding women
  • Poor compliance with dental plaque control after initial therapy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 months

Participants undergo tooth extraction followed by placement of either Erythropoietin carried on chitosan carrier, chitosan carrier alone, or natural healing to preserve the alveolar ridge.

1 visit for extraction and intervention

Follow-up

Duration - 2 weeks after extraction for pain and wound healing assessments; implant placement and biopsy at 4 months post-extraction

Participants are monitored for postoperative pain, wound healing, and bone regeneration including implant placement and biopsy collection.

Approximately 3 visits (postoperative pain and wound healing assessments at 1 and 2 weeks; implant placement visit at 4 months)

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry Ain Shams University

Cairo, Egypt, 11361

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Research Team

M

Marwa El Kassaby

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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