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SRP + MM for Gum Disease

N/A
Recruiting
Led By Arif Salman, DDS
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For periodontally-healthy participants: Diagnosis of healthy periodontium defined as ≤9% of sites bleeding on probing with absence of interproximal attachment loss and bone loss
For randomized participants: Have at least 20 natural teeth with a diagnosis of Periodontitis (stage II, III, or IV)
Must not have
Subjects with conditions requiring prophylactic antibiotics
Use of local or systemic antibiotics within the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 months post procedure
Awards & highlights

Summary

This trial tests if adding tiny antibiotic particles to a deep cleaning procedure helps patients with severe gum disease by reducing harmful bacteria in their gums.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from treatment may include discomfort during dental procedures, sensitivity in treated areas, and potential allergic reactions to minocycline for those sensitive to this medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My gums are healthy with minimal bleeding and no bone loss.
Select...
I have at least 20 natural teeth and have been diagnosed with moderate to severe gum disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need antibiotics to prevent infections.
Select...
I have not taken any antibiotics in the last 3 months.
Select...
I am taking medication that affects gum disease.
Select...
I have had gum disease treatment in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 months post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bleeding on Probing (SRP + MM)
Bleeding on Probing (SRP only)
Change in Clinical Attachment Loss (SRP + MM)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: SRP + MMExperimental Treatment1 Intervention
Scaling and rooting planning in combination with minocycline microspheres
Group II: SRPActive Control1 Intervention
Scaling and rooting planning
Group III: Periodontally-Healthy SubjectsActive Control1 Intervention
No Intervention

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor
181 Previous Clinical Trials
63,666 Total Patients Enrolled
Bausch Health Americas, Inc.Industry Sponsor
262 Previous Clinical Trials
81,991 Total Patients Enrolled
Arif Salman, DDSPrincipal InvestigatorWest Virginia University

Media Library

Scaling and Root Planing (SRP) Clinical Trial Eligibility Overview. Trial Name: NCT05422742 — N/A
Gum Disease Research Study Groups: SRP, SRP + MM, Periodontally-Healthy Subjects
Gum Disease Clinical Trial 2023: Scaling and Root Planing (SRP) Highlights & Side Effects. Trial Name: NCT05422742 — N/A
Scaling and Root Planing (SRP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05422742 — N/A
~11 spots leftby Sep 2025
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