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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05422742
• Other study ID #: 2008078967
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: West Virginia University
• Contact: Arif Salman, DDS
• Phone: 304-293-7429
• Email: arifsalman.abdulshakore[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
West Virginia University	Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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