Guided Bone Regeneration for Horizontal Ridge Deficiency

Overseen By Alice Ou, RDH, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Immunosuppressants

Disqualifiers: Smoking, Alcohol abuse, Pregnancy, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have uncontrolled diabetes, you may not be eligible to participate.

What data supports the effectiveness of the treatment Guided Bone Regeneration (GBR) for horizontal ridge deficiency?

Research shows that guided bone regeneration (GBR) is a reliable method for increasing bone in areas with deficiencies, like horizontal ridge deficiencies, when strict protocols are followed. Studies have demonstrated successful bone growth using GBR techniques, although the best materials to use are still being debated. ^{1 2 3 4 5}

Is guided bone regeneration (GBR) generally safe for humans?

Guided bone regeneration (GBR) is generally considered a safe and reliable technique for bone augmentation, but it requires strict protocols to minimize risks. Some complications, like the penetration of fixation tacks into the maxillary sinus, have been reported, highlighting the importance of careful surgical planning. ^{1 6 7 8 9}

How does the treatment Guided Bone Regeneration (GBR) differ from other treatments for horizontal ridge deficiency?

Guided Bone Regeneration (GBR) is unique because it uses a barrier membrane to direct the growth of new bone in areas with bone loss, making it a reliable option for horizontal ridge augmentation. Unlike other methods, GBR is specifically designed to support dental implants by creating a stable bone structure, although the choice of barrier material is still debated. ^{1 2 3 6 7}

What is the purpose of this trial?

The purpose of this study is to compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM).

Research Team

Hom-Lay Wang, DDS MSD PhD

Principal Investigator

Department of Periodontics and Oral Medicine, University of Michigan

Eligibility Criteria

This trial is for adults over 18 who are healthy or have mild to moderate controlled diseases. They should have missing teeth in the back of their lower jaw with bone defects and be able to understand the study's terms. Smokers, pregnant individuals, those with autoimmune disorders, recent radiotherapy patients, substance abusers, or people with severe organ dysfunction cannot participate.

Inclusion Criteria

I am generally healthy or have a mild to moderate condition that is under control.

I have missing teeth in the back of my lower jaw with bone loss of at least 3mm.

I understand and agree to the study's conditions.

Exclusion Criteria

Autoimmune disorders

Smoking habit of >10 cigarettes/day (self-reported)

I have undergone radiotherapy within the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mandibular ridge augmentation using either Customized CAD/CAM Titanium Mesh or Reinforced Perforated PTFE Mesh

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic and histological assessments

6 months

Treatment Details

Interventions

• Guided Bone Regeneration (GBR)

Trial Overview The study aims to compare two techniques for increasing bone density in the jaw where teeth are missing: using a custom-made titanium mesh versus a reinforced PTFE mesh. The goal is to see which method is better for both vertical and horizontal growth of the jawbone.

Participant Groups

Group I: Customized CAD/CAM Titanium Mesh Experimental Treatment 1 Intervention

A customized CAD/CAM Titanium Mesh will be used to cover the bone graft

Group II: Reinforced Perforated PTFE Mesh (RPM) Active Control 1 Intervention

A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Statements and Recommendations for Guided Bone Regeneration: Consensus Report of the Guided Bone Regeneration Symposium Held in Bologna, October 15 to 16, 2016. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Horizontal guided bone regeneration on knife-edge ridges: A retrospective case-control pilot study comparing two surgical techniques. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Horizontal ridge augmentation using native collagen membrane vs titanium mesh in atrophic maxillary ridges: Randomized clinical trial. [2020]

4. Denmark pubmed.ncbi.nlm.nih.gov

Ridge preservation after ridge expansion with simultaneous guided bone regeneration: a preclinical study. [2017]

5. China pubmed.ncbi.nlm.nih.gov

The influence of initial defect morphology of alveolar ridge on volumetric change of grafted bone following guided bone regeneration in the anterior maxilla region: an exploratory retrospective study. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Dental implants with versus without peri-implant bone defects treated with guided bone regeneration. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Targeted Alveolar Ridge Augmentation for Patient-Centered Dental Implant Site Development. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Guided bone regeneration around endosseous implants with anorganic bovine bone mineral. A randomized controlled trial comparing bioabsorbable versus non-resorbable barriers. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Fixation tack penetration into the maxillary sinus: A case report of a guided bone regeneration procedure complication. [2021]