SRP + MM for Gum Disease

AS
Overseen ByArif Salman, DDS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: West Virginia University
Stay on Your Current MedsYou can continue your current medications while participating
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 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.12345

Why 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?

AS

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

My gums are healthy with minimal bleeding and no bone loss.
I have at least 20 natural teeth and have been diagnosed with moderate to severe gum disease.

Exclusion Criteria

Subjects allergic to any of the tetracyclines
I have diabetes or another condition that can affect gum disease.
I need antibiotics to prevent infections.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Examination

Clinical examination including measurement of clinical attachment loss, probing pocket depth, bleeding on probing, and plaque score. Subgingival plaque biofilms sampled.

1 day
1 visit (in-person)

Treatment

Participants receive full-mouth scaling and root planing (SRP) alone or in combination with minocycline microspheres (MM).

1 day
1 visit (in-person)

Follow-up

Participants are evaluated for clinical outcomes and subgingival plaque samples are collected.

2 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Scaling and Root Planing (SRP)
  • SRP + MM
Trial Overview The study is testing whether adding minocycline microspheres (MM) to standard gum disease treatment (scaling and root planing - SRP) changes the makeup and activity of bacteria under the gums compared to just SRP alone.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: SRP + MMExperimental Treatment1 Intervention
Group II: SRPActive Control1 Intervention
Group III: Periodontally-Healthy SubjectsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials
192
Recruited
64,700+

Bausch Health Americas, Inc.

Industry Sponsor

Trials
265
Recruited
82,000+
Dr. Jonathan Sadeh profile image

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 profile image

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/15536783/
A post-marketing study of 2805 patients treated for ...This study demonstrated that a large study could be conducted in a private practice setting, that Arestin and SRP were effective in reducing pocket depth.
Research Article Effect of scaling and root planing with and ...This study tests the effects of scaling and root planing (SRP) vs SRP with minocycline hydrochloride microspheres (MMs) (SRP with MM) on serum biomarkers.
Study Details | NCT05422742 | Influence of SRP With MM ...The purpose of this study is to characterize the effect of minocycline microspheres (MM) administered as an adjunct to scaling and rooting planning (SRP) on the ...
Effectiveness of Conventional Periodontal Treatment With ...Locally delivered tetracycline and minocycline gel are effective as adjuncts to SRP and may improve the healing outcome in the management of periodontitis.
ARESTIN | Clinical Efficacy“After 1 month of treatment, patients receiving SRP plus minocycline microspheres had a significantly greater mean reduction in PD when compared with vehicle ...
New Clinical Study Suggests the Use of OraPharma's ...This study identified that the administration of minocycline HCI microspheres, 1mg did significantly decrease specific periodontal pathogens.
Gum disease is caused by bacteria.1 Fight infection by ...ARESTIN® (minocycline HCl) Microspheres, 1 mg is used in combination with scaling and root planing (SRP) procedures to treat patients with adult periodontitis ( ...
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/12789964/
Minocycline microspheres: a complementary medical- ...Minocycline microspheres plus SRP are safe in patients and more effective than SRP alone in reducting the signs of chronic periodontitis.
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