Influence of Scaling and Root Planing With Minocycline Microspheres on the Composition and Functional Characteristics of Subgingival Microbiome Communities

NCT05422742 NA ACTIVE_NOT_RECRUITING

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 metatranscriptome functional profile, in comparison to a group treated with SRP only and to periodontally-healthy subjects.

Details

Lead sponsor	West Virginia University
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	50
Start date	2021-10-15
Completion	2025-12

Conditions

• Periodontitis

Interventions

• SRP + MM
• Scaling and Root Planing (SRP)

Primary outcomes

• Change in Clinical Attachment Loss (SRP + MM) — baseline to 2 months post procedure
  Change in Clinical Attachment Loss which is a routine clinical measure of periodontal health (measured in mm) from baseline to 2 months post procedure
• Change in Clinical Attachment Loss (SRP only) — baseline to 2 months post procedure
  Change in Clinical Attachment Loss which is a routine clinical measure of periodontal health (measured in mm) from baseline to 2 months post procedure
• Probing Pocket Depth (SRP + MM) — Baseline to 2 months post procedure
  Change in Probing depth is a routine clinical measure of periodontal health (measured in mm)
• Probing Pocket Depth (SRP only) — Baseline to 2 months post procedure
  Change in Probing depth is a routine clinical measure of periodontal health (measured in mm)
• Bleeding on Probing (SRP + MM) — Baseline to 2 months post procedure
  Change in Bleeding on Probing is a measure of inflammation and determined as the percent of bleeding sites that are measured at 6 sites per tooth
• Bleeding on Probing (SRP only) — Baseline to 2 months post procedure
  Change in Bleeding on Probing is a measure of inflammation and determined as the percent of bleeding sites that are measured at 6 sites per tooth

Countries

United States