Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Clinical Attachment Loss (CAL)
研究概览
简要总结
The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients.
详细描述
The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. Patients' enrollment will be conducted according to inclusion criteria.
At the first visit, periodontal parameters will be recorded: Plaque Index (PI), recession (R) Bleeding on Probing (BoP), modified Marginal Gingival Index (mMGI), Papillary Marginal Gingival (PMGI), Plaque Control Record ( PCR %), Approximal Plaque Index (API), Clinical Attachment loss (CAL) and Probing Pocket Depth (PPD).
Professional debridement will be conducted with piezoelectric instrumentation and air-flow administration with glycine powders.
Subsequently, patients will be randomly divided into two groups:
- the Probiotic group, in which patients will undergo daily probiotic supplementation in addition to the standard treatment
- the Control group, in which patients will undergo standard treatment
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Products will be concealed.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women at the 4th month of pregnancy
排除标准
- •presence of cardiac pacemaker
- •neurological and psychiatric diseases
- •patients taking bisphosphonates during the previous 12 months from the beginning of the study
- •patients undergoing anticancer therapy.
- •patients with poor compliance.
结局指标
主要结局
Change in Clinical Attachment Loss (CAL)
时间窗: Baseline, 1, 3 and 6 months
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Change in Plaque Index
时间窗: Baseline, 1, 3 and 6 months
Scoring criteria: 0 = no plaque; 1. = thin plaque layer at the gingival margin, only detectable by scraping with a probe; 2. = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; 3. = abundant plaque along the gingival margin; interdental spaces filled with plaque.
Change in Recession (R)
时间窗: Baseline, 1, 3 and 6 months
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in Bleeding on Probing (BoP)
时间窗: Baseline, 1, 3 and 6 months
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%.
Change in Papillary Marginal Gingival Index (PMGI)
时间窗: Baseline, 1, 3 and 6 months
Numerical score from 0 to 3 of gingival inflammation. Papille and gingival margins (vestibular and lingual) are given a score from 0 to 3. The score is given by the total amount of inflamed sites on the total of examined sites.
Change in modified Marginal Gingival Index (mMGI)
时间窗: Baseline, 1, 3 and 6 months
Scoring criteria: 0 = Absence of inflammation 1. = Mild inflammation (marginal or papillary unit) 2. = Mild inflammation (entire marginal and papillary unit) 3. = Moderate inflammation 4. = Severe inflammation
Change in Probing Pocket Depth (PPD)
时间窗: Baseline, 1, 3 and 6 months
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Change in API - Approximal Plaque Index
时间窗: Baseline, 1, 3 and 6 months
Following application of disclosing, a simple yes/no decision is made concerning whether the interproximal surfaces are covered by plaque (+) or not (-). The proportion of plaque-covered interproximal spaces is expressed as a percentage. Usually, in a given quadrant the interproximal spaces are scored from only one aspect (i.e. from the facial - Q2 and Q4 - or from the oral aspect - Q1 and Q3).
Change in Plaque Control Record (PCR%)
时间窗: Baseline, 1, 3 and 6 months
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia