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

Trial Summary

What is the purpose of this trial?

The primary aims of this study are to compare, after 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+