40 Participants NeededMy employer runs this trial

Grafting for Alveolar Bone Loss

IG
TZ
Overseen ByTara Zhou
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Virginia Commonwealth University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Ossix mineralized grafting to address bone loss in the jaw after tooth removal. The goal is to determine whether grafting immediately after tooth removal or later during implant placement better maintains bone height for successful dental implants. Individuals with at least 6 mm of bone height after tooth extraction and minimal surrounding damage may qualify. The trial seeks to reduce discomfort and improve outcomes for those needing dental implants. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future dental implant procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this grafting method is safe for dental procedures?

Research has shown that the materials used in Ossix mineralized grafting are generally safe for patients. Studies have found that Ossix products, such as Ossix Plus and Ossix Agile, have received FDA approval and are frequently used in dental procedures. These materials are designed to be compatible with the body, meaning they integrate well and break down safely over time.

However, some important considerations exist. People allergic to collagen or materials derived from pigs should not use Ossix products. Although these allergies are rare, awareness is crucial.

Overall, the treatment is considered safe due to its regular use in dental care and FDA approval.12345

Why are researchers excited about this trial?

Researchers are excited about the grafting treatments for alveolar bone loss because they utilize Ossix products, which are known for their advanced resorbable collagen membranes and bone graft materials. Unlike traditional grafting methods, these treatments use Ossix Plus and Ossix Agile, both FDA-approved and designed to integrate seamlessly with the body's natural healing processes. The Ossix products stand out for their ability to enhance bone regeneration while minimizing complications due to their resorbable nature, which means they gradually dissolve, eliminating the need for surgical removal. This innovative approach could lead to more efficient and comfortable recovery for patients undergoing dental procedures.

What evidence suggests that this trial's treatments could be effective for alveolar bone loss?

This trial will compare immediate grafting with delayed grafting using Ossix materials. Studies have shown that Ossix mineralized grafting effectively rebuilds jawbone, which is crucial for successful dental implants. Research indicates that Ossix products can result in an average of 43.8% new bone growth. More bone provides better support for dental implants. Additionally, case reports have demonstrated successful implant placements with strong tissue and bone support when using Ossix materials. Praised for their ease of shaping and stability, these materials aid in the reliable growth of new bone. Overall, research supports the use of Ossix grafting materials in dental procedures.14567

Who Is on the Research Team?

IG

Iya Ghassib

Principal Investigator

Virginia Commonwealth University

SA

Sandra Al-Tarawneh

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults needing a maxillary molar extraction who have at least 6 mm of bone height left, minimal damage to the socket walls (less than 5mm), and enough space between tooth roots and sinus. People with major bone loss or other dental complications are not eligible.

Inclusion Criteria

My gum and palate have no gaps or gaps smaller than 5mm.
* Initial residual bone height (RBH) of at least 6 mm. 3-A minimum distance of 1 mm between root apices and sinus membrane.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Grafting

Participants receive immediate grafting using Ossix Plus and Ossix bone graft after extraction

Immediate post-extraction
1 visit (in-person)

Delayed Grafting

Grafting performed after extraction and at the time of implant placement using Ossix Agile and Ossix bone graft

At implant placement
1 visit (in-person)

Follow-up

Participants are monitored for clinical and radiographic outcomes post-implant

1 year
2 week, 6 month, and 1 year visits

What Are the Treatments Tested in This Trial?

Interventions

  • Ossix mineralized grafting

Trial Overview

The study compares two approaches: placing a mineralized bone graft right after tooth extraction versus waiting to place the graft later when the dental implant is put in. The goal is to see which method better preserves jawbone thickness and height.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Immediate GraftingExperimental Treatment1 Intervention
Group II: Delayed GraftingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

Dentsply Sirona Inc.

Industry Sponsor

Trials
3
Recruited
180+

Citations

Power of OSSIX® Products

OSSIX® products are at the forefront of dental regeneration, offering advanced solutions for guided bone and tissue regeneration and backed by research, case ...

Advancements in alveolar bone grafting and ridge preservation

This narrative review systematically explores the progression of materials and techniques in alveolar ridge preservation (ARP).

K212509 - Janice Hogan - accessdata.fda.gov

OSSIX® Breeze cross-linked pericardium membrane is a biodegradable and biocompatible collagen membrane intended for guided tissue and bone ...

Regenerating Alveolar Bone for Implant Placement

The findings suggest that AMD grafts resulted in an average (and 95% confidence interval) of 43.8% [36.6%, 50.8%] newly formed bone, and delayed implant ...

Antibiotic Prophylaxis Versus Placebo in Alveolar Bone ...

This randomized, double-blind, placebo-controlled clinical trial aims to compare the effects of prophylactic amoxicillin versus placebo on postoperative ...

Grafting for Alveolar Bone Loss

Dental implants are a fixed replacement solution with reported long-term survival rates between 94-98% over 20-40 years.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30161278/

Ridge preservation following tooth extraction using ...

This study provides the first histologic comparison between the wound healing of FDBA and SDBA over a 12-week healing period in a ridge preservation ...