SRP + MM for Gum Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of minocycline microspheres (tiny antibiotic particles) combined with scaling and root planing (deep cleaning) for gum disease. Researchers compare this combination to deep cleaning alone and to individuals with healthy gums. It targets those with gum disease, specifically periodontitis, and at least 20 natural teeth. Recent dental cleanings, smoking, or certain medications may disqualify participation. As an unphased trial, this study provides a unique opportunity to contribute to understanding new treatment combinations for gum disease.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications, especially if they affect gum disease, are non-steroidal anti-inflammatory drugs, or are antibiotics. The trial excludes participants currently using these medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using minocycline microspheres (MM) with scaling and root planing (SRP) is safe for patients. This combination reduces gum disease symptoms more effectively than SRP alone. After one month, patients who received both MM and SRP showed a greater decrease in gum pocket depth, a sign of gum disease, compared to those who did not use MM.
The treatment also significantly reduces harmful bacteria in the gums, suggesting it helps manage current gum disease and fights infection. Overall, minocycline microspheres are well-tolerated, with no major safety concerns reported in the studies.12345Why are researchers excited about this trial?
Researchers are excited about the combination treatment of Scaling and Root Planing (SRP) with minocycline microspheres (MM) for gum disease because it offers a novel approach to managing the condition. Unlike traditional treatments, which mainly involve mechanical cleaning through SRP, this approach introduces minocycline, an antibiotic, directly into the gums via microspheres. This targeted delivery system not only enhances the effectiveness of the treatment by directly combating bacteria at the site of infection but also potentially reduces the need for systemic antibiotics, minimizing side effects. This innovative combination could lead to more effective and efficient periodontal care.
What evidence suggests that this trial's treatments could be effective for gum disease?
Research has shown that using minocycline microspheres (MM) with scaling and root planing (SRP) can improve gum health. In this trial, one group of participants will receive SRP alone, while another group will receive SRP combined with MM. Studies have found that adding MM to SRP leads to a greater reduction in pocket depth, an important sign of gum disease. Specifically, one study found that patients who received this combination treatment healed better than those who only had SRP. Additionally, large studies in real-world settings have confirmed that SRP with MM effectively manages gum disease. These findings suggest that adding MM to SRP could be a promising way to treat gum disease.35678
Who Is on the Research Team?
Arif Salman, DDS
Principal Investigator
West Virginia University
Are You a Good Fit for This Trial?
This trial is for adults with at least 20 natural teeth who have been diagnosed with Periodontitis (stage II, III, or IV). It's also open to those with healthy gums. People can't join if they don't meet the specific dental health criteria set by the researchers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Examination
Clinical examination including measurement of clinical attachment loss, probing pocket depth, bleeding on probing, and plaque score. Subgingival plaque biofilms sampled.
Treatment
Participants receive full-mouth scaling and root planing (SRP) alone or in combination with minocycline microspheres (MM).
Follow-up
Participants are evaluated for clinical outcomes and subgingival plaque samples are collected.
What Are the Treatments Tested in This Trial?
Interventions
- Scaling and Root Planing (SRP)
- SRP + MM
Find a Clinic Near You
Who Is Running the Clinical Trial?
West Virginia University
Lead Sponsor
Bausch Health Americas, Inc.
Industry Sponsor
Dr. Jonathan Sadeh
Bausch Health Americas, Inc.
Chief Medical Officer
MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School
Thomas J. Appio
Bausch Health Americas, Inc.
Chief Executive Officer since 2021
Bachelor's degree in Biology from Rutgers University