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Xenograft

Shefabone for Alveolar Bone Loss

Phase 2
Waitlist Available
Led By Mohanad Al-Sabbagh, DDS
Research Sponsored by Rachad Kudsi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.5 months
Awards & highlights

Study Summary

This trial is comparing the use of a synthetic bone substitute to a commonly used xenograft material in an augmented maxillary sinus.

Eligible Conditions
  • Alveolar Bone Loss
  • After-effects
  • Tooth Extrusion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements
Secondary outcome measures
Bone Quality

Trial Design

2Treatment groups
Experimental Treatment
Group I: Test GroupExperimental Treatment1 Intervention
The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
Group II: Control GroupExperimental Treatment1 Intervention
Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shefabone
2020
Completed Phase 2
~30
Bio-Oss
2005
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

Rachad KudsiLead Sponsor
Mohanad Al-SabbaghLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Mohanad Al-Sabbagh, DDSPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this clinical trial?

"This clinical trial seeks 20 individuals, aged between 20 and 75, with a history of tooth extrusion. To be eligible for the study, candidiates must have an edentulous site in their maxillary arch that requires sinus grafting and implantation."

Answered by AI

How many participants is the clinical trial enrolling?

"Affirmative, the requisite information found on clinicaltrials.gov demonstrates that this study is actively searching for participants. This research project was first announced on June 17th 2020 and modifications were made most recently on November 16th 2022. The trial requires 20 individuals to be admitted from 1 location."

Answered by AI

Does the study protocol permit enrolment of participants above 30 years old?

"To be considered for this trail, applicants must fall within the age range of 20 to 75 years old. Additionally, there are 19 trials specifically targeting individuals under 18 and those over 65 respectively."

Answered by AI

Is enrollment currently open for the trial?

"Affirmative. Clinicaltrials.gov provides evidence that this particular trial is actively enrolling, having been posted on June 17th 2020 and last updated November 16th 2022. The research team has a goal of recruiting 20 patients to be studied at 1 location."

Answered by AI

What risks, if any, do people run when utilizing Shefabone?

"Shefabone's safety is rated as 2 on our 1-3 scale due to the fact that this Phase 2 trial has some evidence of its security, but no data indicating effectiveness."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
New Jersey
Virginia
Other
How old are they?
18 - 65
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
~5 spots leftby Apr 2025