40 Participants Needed

Guided Bone Regeneration for Horizontal Ridge Deficiency

DD
AO
Overseen ByAlice Ou, RDH, MS
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 explores ways to improve the health of gums and bone around dental implants for individuals with jawbone loss. Researchers are testing whether adding a soft tissue graft substitute on top of a bone graft can enhance the area's appearance, health, and stability. The study includes two treatment groups: one using a collagen membrane and the other using an acellular dermal matrix, a type of tissue substitute. Individuals who have lost a tooth and have a thin gum type in certain jaw areas might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative dental research that could enhance future treatments.

Do I need to stop taking my current medications for the trial?

If you are taking medications that affect bone metabolism or wound healing, like bisphosphonates or corticosteroids, you may not be eligible for the trial. The protocol does not specify a washout period, but these medications are part of the exclusion criteria.

What prior data suggests that these guided bone regeneration techniques are safe?

Research has shown that guided bone regeneration using acellular dermal matrix is generally well-tolerated. Studies have found that this method can increase bone size and improve tissue thickness. In past research, the acellular dermal matrix was safely used with other materials to support bone growth and stability.

For the collagen membrane method, studies indicate it is a safe and effective way to encourage bone growth in areas where bone is missing. Research demonstrates that using a collagen membrane can successfully increase bone mass. This method has a high success rate for implants, meaning it usually works well and is safe for patients.

Overall, both methods have demonstrated positive safety records in research, with reported benefits for bone and tissue health.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for horizontal ridge deficiency because they explore innovative materials that may enhance bone regeneration. Traditional treatments often use collagen membranes to support bone growth. However, one of the study treatments uses an acellular dermal matrix, a type of allogenic material that could potentially integrate more effectively with the patient's tissue, promoting more robust and natural bone regeneration. This approach might offer improved outcomes in bone healing and stability compared to standard options.

What evidence suggests that this trial's treatments could be effective for horizontal ridge deficiency?

Research has shown that guided bone regeneration using acellular dermal matrix (ADM), a treatment in this trial, can strengthen and stabilize bone grafts. This technique has yielded good results in medical settings, although animal tests have not demonstrated significant superiority over other methods. Another treatment option in this trial involves using a collagen membrane for guided bone regeneration. Studies have found that this method reliably increases bone width and successfully addresses serious bone issues, resulting in stronger bones. Both treatments in this trial aim to enhance the health and appearance of the bone around dental implants.12356

Who Is on the Research Team?

MS

Muhammad Saleh, BDS, MSD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with horizontal ridge deficiency, which means they have bone loss in their jaw that affects how dental implants can be placed. The study is looking for participants who need a single dental implant and are suitable candidates for bone grafting.

Inclusion Criteria

I am generally healthy or have a mild to moderate condition that is under control.
I am 18 years old or older.
Patients willing to sign the informed consent
See 4 more

Exclusion Criteria

I am not on medications that affect bone health or wound healing.
Allergy to the graft materials
Pregnant subjects or individuals who self-report as attempting to become pregnant
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an implant with simultaneous guided bone regeneration, with half also receiving an acellular dermal matrix graft

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Guided Bone Regeneration with Acellular Dermal Matrix
  • Guided Bone Regeneration with Collagen Membrane
Trial Overview The study tests if adding a soft tissue graft substitute (acellular dermal matrix) over the bone graft during guided bone regeneration provides better outcomes than using just a collagen membrane when placing dental implants.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Guided bone regeneration with Phenotype modification.Experimental Treatment2 Interventions
Group II: Guided bone regenerationActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Citations

Guided bone regeneration: materials and biological ...Biomechanical analyses have shown that ADM has better strength and stiffness than cellular dermal membrane 71. Moreover, ADM has been clinically applied for ...
Guided Bone Regeneration for Horizontal Ridge DeficiencyThe purpose of this study is to determine whether putting a soft tissue graft substitute over the bone graft will provide an increased benefit for improving the ...
A Prospective Study: Alveolar Ridge Augmentation Using ...The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone ...
Simultaneous Implant and Guided Bone Regeneration ...In animal studies, there were no statistically significant differences between the groups 16 weeks after employing GBR with ADM as a barrier ...
Guided bone regeneration versus screw-tenting techniquesThe aim of this study was to systematically review bone volume changes obtained via the use of the Guided. Bone Regeneration Technique (GBR-T) versus the ...
Ridge Preservation With Acellular Dermal Matrix and ...This study describes clinical and histologic outcomes for two commercially available biomaterials for ridge preservation, when used as membrane ...
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