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Bone Graft

Xenograft and allograft for Alveolar Ridge Deficiency

Phase 4

Recruiting

Led By Eswar Kandaswamy, MS

Research Sponsored by Louisiana State University Health Sciences Center in New Orleans

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 6-9 months

Awards & highlights

Study Summary

"This trial aims to study the results of a procedure that enhances the width of the jawbone using a combination of bone material and a collagen membrane that can be absorbed by the body."

Who is the study for?

This trial is for adults over 18 needing bone augmentation before dental implants, who can follow up for 6-9 months, are in good health (ASA I or II), non-smokers, and able to undergo surgery. It's not for those with jaw radiation history, uncontrolled diabetes, HIV/hepatitis, pregnancy plans within 6 months, bisphosphonate use, untreated chronic periodontitis, failed prior implant at the site, immune issues or active infection/pathology at the treatment site.Check my eligibility

What is being tested?

The study tests horizontal ridge augmentation using a mix of demineralized human bone (allograft) layered with animal-derived bone (xenograft) under a collagen membrane. The goal is to see how well this combination works for patients needing more bone width before getting dental implants.See study design

What are the potential side effects?

While specific side effects aren't listed here as it's a surgical procedure rather than drug administration; potential risks may include pain at the surgery site, swelling, bruising and less commonly infection or graft failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-9 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

Amount of graft shrinkage

Amount of horizontal bone gain

Percentage of Vital bone

Secondary outcome measures

Incidence of surgical complications

Trial Design

1Treatment groups

Experimental Treatment

Group I: Xenograft and allograftExperimental Treatment1 Intervention

The group will consist of patients receiving horizontal ridge augmentation using a combination of Demineralized Freeze Dried Bone Allograft (DFDBA) layered with xenograft particulate bone using a resorbable collagen membrane. The DFDBA will be used internally in contact with the native bone and xenograft will be layered buccal to it.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Geistlich PharmaUNKNOWN

Louisiana State University Health Sciences Center in New OrleansLead Sponsor

114 Previous Clinical Trials

43,988 Total Patients Enrolled

Eswar Kandaswamy, MSPrincipal InvestigatorLSUHSC School of Dentistry

Frequently Asked Questions

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

Is the enrollment phase for this investigation currently ongoing?

"Affirmative, the details available on clinicaltrials.gov reveal that this investigation is presently seeking individuals to participate. The study was initially disclosed on March 27th, 2024, and most recently revised on the same date. Enrollment aims to secure a cohort of 15 volunteers from one designated site."

Answered by AI

What is the current number of participants being recruited for this research study?

"Affirmative. Records on clinicaltrials.gov reveal that this particular medical investigation is actively seeking participants. Originally shared on March 27, 2024, the trial has since been updated as of the same date and aims to enroll a total of 15 subjects at one designated facility."

Answered by AI

Have Xenograft and allograft been sanctioned by the FDA for use in medical treatment?

"Given that this intervention is endorsed due to its approval status, the safety rating for Xenograft and allograft treatment has been designated as 3 on our assessment scale at Power."

Answered by AI

Who else is applying?

What site did they apply to?

LSUHSC School of Dentistry

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I have several missing teeth in a row along the top and bottom of my mouth and I can feel the shrinkage of my gums. Therefore, I know I would never be able to get implants. Dental work is something I wish I can afford.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Prospective Clinical Study

2024. "Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Prospective Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06342973.

All > New Orleans