Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05422742

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

About this study

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 probing pocket depth (PPD) >4 mm; at least 1 tooth with a PPD >6 mm and clinical attachment loss (CAL) ≥2 mm, and radiographic evidence of bone loss will be recruited.

Clinical examination will include measurement of clinical attachment loss (CAL), probing pocket depth (PPD), bleeding on probing (BOP), and plaque score (PS) at 6 sites per tooth. Furcation involvement (FI) will also be recorded. Radiographic examination will include full-mouth radiographic series. Patients will receive a clinical examination at baseline (V1, before periodontal therapy), and their subgingival plaque biofilms will be sampled at a second visit (V2) two weeks after this initial exam to collect subgingival plaque not disrupted by the examination procedures.

Subjects will be then randomized to one of two groups: SRP only and SRP + MM. Periodontal therapy will consist of one visit (V3) full-mouth SRP alone or in combination with MM placed at all sites regardless of PPD. Each site will receive 1mg of MM for a total of 6mg of MM per tooth. In this manner we will also evaluate whether MM modifies the microbiome of shallow sites, since subgingival microbiome dysbiosis affects shallow sites of subjects with periodontitis and therefore represents a risk for future disease progression.

Subjects will be evaluated 2 months after receiving periodontal therapy (V4). At this visit subgingival plaque samples will be collected and clinical outcomes evaluated. Clinical examinations and plaque collection will be conducted by one calibrated examiner.

Fifteen periodontally-healthy subjects will also be recruited from the West Virginia University School of Dentistry Clinics. Subjects will receive a clinical examination and their subgingival communities sampled at the same visit (V1).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Clinical Attachment Loss (SRP + MM)

    Time frame: 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

  2. Change in Clinical Attachment Loss (SRP only)

    Time frame: 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

  3. Probing Pocket Depth (SRP + MM)

    Time frame: Baseline to 2 months post procedure

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

  4. Probing Pocket Depth (SRP only)

    Time frame: Baseline to 2 months post procedure

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

  5. Bleeding on Probing (SRP + MM)

    Time frame: 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

  6. Bleeding on Probing (SRP only)

    Time frame: 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

  7. Plaque Score (SRP + MM)

    Time frame: Baseline to 2 months post procedure

    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.

  8. Plaque Score (SRP only)

    Time frame: Baseline to 2 months post procedure

    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.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 16, 2022
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.