Guided Bone Regeneration for Ridge Augmentation

Overseen By Himabindu Dukka, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Must not be taking: IV bisphosphonates, Oral bisphosphonates, NSAIDs, Steroids

Disqualifiers: Osteonecrosis, Head/neck radiation, Chemotherapy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore different techniques in guided bone regeneration, a process that builds up bone in needed areas, such as for dental implants. Researchers seek to determine if making tiny holes in the bone marrow (intra-marrow penetrations) enhances bone growth compared to not making these holes. Participants will receive the procedure either with or without these holes. Ideal candidates are healthy adults needing jaw bone regeneration and not taking certain medications, such as bisphosphonates.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve future dental treatments.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on long-term NSAID or steroid therapy, or if you have been treated with bisphosphonates for certain durations.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that making small holes in the bone, known as intra-marrow penetrations, benefits similar procedures. These procedures are usually well-tolerated, with studies showing only minor differences in healing and bone changes, suggesting the treatment is generally safe for most people.

For the other method in this trial, which does not involve making holes in the bone, researchers expect similar safety. Techniques like guided bone regeneration, used in this trial, are common and usually safe, with few side effects reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for guided bone regeneration with intra-marrow penetrations because it explores a potentially more effective way to prepare the jawbone for dental implants. Unlike traditional methods that rely on bone grafts alone, this technique involves creating small penetrations in the bone marrow to possibly enhance blood flow and promote better integration of the graft. By comparing this method to the standard grafting process without penetrations, researchers aim to determine if the new technique offers superior outcomes in bone healing and stability, potentially leading to improved success rates for dental implants.

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

In this trial, participants will receive guided bone regeneration therapy with or without intra-marrow penetrations (IMPs). Research has shown that IMPs can enhance bone healing, leading to improved bone growth. IMPs encourage blood vessel growth and supply essential cells for bone repair. Studies suggest that IMPs can increase the success of bone grafts by creating a more favorable environment for bone growth. This method has been reported to aid in the effective regeneration of bone needed for dental implants. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals needing ridge augmentation, a dental procedure to rebuild the jawbone. Participants should be suitable candidates for guided bone regeneration but cannot have conditions that would interfere with bone healing or be taking medications affecting bone turnover.

Inclusion Criteria

Patients must sign an informed consent approved by the University of Louisville Human Studies Committee

Exclusion Criteria

I have a serious illness that affects my gums.

I am currently on IV bisphosphonates or have been treated with them before.

I have been on oral bisphosphonates for over three years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Presurgical Management

Diagnostic work-up including radiographs, CBCT scan, study casts, clinical photographs, and clinical examination. Presurgical preparation includes oral hygiene instructions.

1-2 weeks

Treatment

Guided bone regeneration procedures with or without intra-marrow penetrations. Full thickness flap for ridge augmentation is performed.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Clinical and histologic measurements are taken at 6 months.

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intra-marrow penetrations
• No Intra-marrow penetrations

Trial Overview The study is examining if making small holes in the jawbone (intra-marrow penetrations) during guided bone regeneration helps improve clinical and histologic outcomes after 6 months compared to not making these holes.

How Is the Trial Designed?

Group I: Intra-marrow penetrations Experimental Treatment 1 Intervention

Twelve test patients will receive guided bone regeneration therapy with the use of intra-marrow penetrations prior to bone graft placement.

Group II: No Intra-marrow penetrations Active Control 1 Intervention

Twelve test patients will receive guided bone regeneration therapy without the use of intra-marrow penetrations prior to bone graft placement.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10157995/

Intra-marrow penetrations and root coverage outcomes Intra-marrow penetrations (IMPs) have been performed during guided tissue regeneration (GTR) procedures with reported clinical benefits.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0300571225000570

Regenerative approaches in alveolar bone augmentation ... This review aimed to evaluate the outcomes of ridge augmentation techniques and bio-materials for alveolar bone regeneration, addressing inconsistencies across ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4040931/

Mechanisms of Guided Bone Regeneration: A Review - PMC To regenerate enough bone for successful implant placement, a ridge augmentation technique is often required. One technique of ridge augmentation is Guided Bone ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/prd.12471

Techniques on vertical ridge augmentation: Indications and ... 3 Effectiveness based on clinical studies. Several studies report on the effectiveness of guided bone regeneration in achieving vertical bone ...

5. deepblue.lib.umich.edu deepblue.lib.umich.edu/bitstream/handle/2027.42/141560/jper1231.pdf?sequence=1

Effect of Ridge Morphology on Guided Bone Regeneration ... In addition, intramarrow penetration provides angiogenesis and undifferen- tiated mesenchymal cells that are essential for. GBR.25-29 Hence, we postulated the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6954934/

Evaluation of Alveolar Ridge Height Gained by Vertical ... This report demonstrates the remarkable efficacy of guided bone regeneration using a combination of titanium mesh and novabone putty for vertical ridge ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/prd.12518

Bone regeneration in implant dentistry: Which are the ... A number of studies indicated minimal differences in short- and moderate-term healing outcomes, as well as crestal bone level changes between ...

8. researchgate.net researchgate.net/publication/364374949_Review_of_the_Long-Term_Outcomes_of_Guided_Bone_Regeneration_and_Autologous_Bone_Block_Augmentation_for_Vertical_Dental_Restoration_of_Dental_Implants

(PDF) Review of the Long-Term Outcomes of Guided Bone ... We aimed to review the current status of guided bone regeneration and autologous bone block augmentation for vertical dental restoration of dental implants.