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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
No Placebo-Only Group
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 months post procedure
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
183 Previous Clinical Trials
63,820 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My gums are healthy with minimal bleeding and no bone loss.I have diabetes or another condition that can affect gum disease.I need antibiotics to prevent infections.I have not taken any antibiotics in the last 3 months.I have at least 20 natural teeth and have been diagnosed with moderate to severe gum disease.I had a dental cleaning in the last 3 months.I use non-steroidal anti-inflammatory drugs.I am taking medication that affects gum disease.I have had gum disease treatment in the last year.I have at least 20 natural teeth and have been diagnosed with moderate to severe gum disease.You have healthy gums with no signs of bleeding or bone loss around your teeth.
Research Study Groups:
This trial has the following groups:- Group 1: SRP
- Group 2: SRP + MM
- Group 3: Periodontally-Healthy Subjects
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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