Status:
ACTIVE_NOT_RECRUITING
Influence of SRP With MM on the Composition and Functional Characteristics of Subgingival Microbiome Communities
Lead Sponsor:
West Virginia University
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Periodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 subgingival community composition and m...
Detailed Description
Patients attending the West Virginia University School of Dentistry Clinics will be invited to participate in this study. Thirty periodontitis patients (stage II, III or IV) with ≥4 teeth with a probi...
Eligibility Criteria
Inclusion
- Inclusion Criteria for randomized participants:
- Have at least 20 natural teeth with a diagnosis of Periodontitis (stage II, III, or IV).
- Inclusion Criteria 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
- Exclusion Criteria for all participants:
- Pregnancy or lactation
- Patients with diabetes mellitus or any other systemic disease that can modify periodontitis
- Current smokers
- Current use of f any medication with known effects on periodontitis
- Use of non-steroidal anti-inflammatory drugs
- Use of local or systemic antibiotics within the last 3 months
- Subjects with conditions requiring prophylactic antibiotics
- Subjects allergic to any of the tetracyclines
- Professional dental cleaning within the last 3 months
- SRP or surgical periodontal therapy in the previous year
Exclusion
Key Trial Info
Start Date :
October 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05422742
Start Date
October 15 2021
End Date
December 1 2025
Last Update
July 22 2025
Active Locations (1)
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1
West Virginia University
Morgantown, West Virginia, United States, 26506