Influence of Scaling and Root Planing With Minocycline Microspheres on the Composition and Functional Characteristics of Subgingival Microbiome Communities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Plaque Score (SRP only)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SRP
Scaling and rooting planning
干预措施: Scaling and Root Planing (SRP) (Procedure)
SRP + MM
Scaling and rooting planning in combination with minocycline microspheres
干预措施: SRP + MM (Procedure)
Periodontally-Healthy Subjects
No Intervention
结局指标
主要结局
Plaque Score (SRP only)
时间窗: 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.
Change in Clinical Attachment Loss (SRP only)
时间窗: 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
Plaque Score (SRP + MM)
时间窗: 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.
Change in Clinical Attachment Loss (SRP + MM)
时间窗: 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
Bleeding on Probing (SRP + MM)
时间窗: 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)
时间窗: 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
Probing Pocket Depth (SRP only)
时间窗: 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 + MM)
时间窗: Baseline to 2 months post procedure
Change in Probing depth is a routine clinical measure of periodontal health (measured in mm)
次要结局
未报告次要终点