Influence of SRP With MM on the Composition and Functional Characteristics of Subgingival Microbiome Communities

NCT05422742 | Active Not Recruiting

• 1 other identifier: 2008078967
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (8)

• Change in Clinical Attachment Loss (SRP + MM)

  Change in Clinical Attachment Loss which is a routine clinical measure of periodontal health (measured in mm) from baseline to 2 months post procedure

  baseline to 2 months post procedure

• Change in Clinical Attachment Loss (SRP only)

  Change in Clinical Attachment Loss which is a routine clinical measure of periodontal health (measured in mm) from baseline to 2 months post procedure

  baseline to 2 months post procedure

• Probing Pocket Depth (SRP + MM)

  Change in Probing depth is a routine clinical measure of periodontal health (measured in mm)

  Baseline to 2 months post procedure

• Probing Pocket Depth (SRP only)

  Change in Probing depth is a routine clinical measure of periodontal health (measured in mm)

  Baseline to 2 months post procedure

• Bleeding on Probing (SRP + MM)

  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

  Baseline to 2 months post procedure

• Bleeding on Probing (SRP only)

  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

  Baseline to 2 months post procedure

• Plaque Score (SRP + MM)

  Change in O'Leary plaque score. Plaque score will be assessed dichotomously. Score 1 when plaque is identifiable using a dental probe or score 0 when no plaque is present. Following this assessment, plaque score is calculated by dividing the number of plaque containing surfaces by the total number of surfaces examined.

  Baseline to 2 months post procedure

• Plaque Score (SRP only)

  Change in O'Leary plaque score. Plaque score will be assessed dichotomously. Score 1 when plaque is identifiable using a dental probe or score 0 when no plaque is present. Following this assessment, plaque score is calculated by dividing the number of plaque containing surfaces by the total number of surfaces examined.

  Baseline to 2 months post procedure

Study Arms (3)

SRP

ACTIVE COMPARATOR

Scaling and rooting planning

Procedure: Scaling and Root Planing (SRP)

SRP + MM

EXPERIMENTAL

Scaling and rooting planning in combination with minocycline microspheres

Procedure: SRP + MM

Periodontally-Healthy Subjects

NO INTERVENTION

No Intervention

Interventions

SRP + MM PROCEDURE

Subjects will be randomized into either SRP only or SRP +MM. Periodontal therapy will consist of one visit full-month SRP alone or in-combination with MM placed at all sites regardless of probing pocket depth. Each site will recieve 1mg of MM for a total of 6mg of MM per tooth.

SRP + MM

Scaling and Root Planing (SRP) PROCEDURE

Procedure involving removal of dental plaque and calculus (scaling or debridement) and then smoothing, or planing, of the (exposed) surfaces of the roots, removing cementum or dentine that is impregnated with calculus, toxins, or microorganisms, the etiologic agents that cause inflammation.

SRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least 20 natural teeth with a diagnosis of Periodontitis (stage II, III, or IV).
• Diagnosis of healthy periodontium defined as ≤9% of sites bleeding on probing with absence of interproximal attachment loss and bone loss

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Arif Salman, DDS

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: October 15, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)