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

NCT ID: NCT05422742

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2025-12-31

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.

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 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).

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SRP

Scaling and rooting planning

Group Type: ACTIVE_COMPARATOR

Scaling and Root Planing (SRP)

Intervention Type: 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 + MM

Scaling and rooting planning in combination with minocycline microspheres

Group Type: EXPERIMENTAL

SRP + MM

Intervention Type: 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.

Periodontally-Healthy Subjects

No Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SRP + MM

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.

Intervention Type: PROCEDURE

Scaling and Root Planing (SRP)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arif Salman, DDS

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

2008078967

Identifier Type: -

Identifier Source: org_study_id