Non-surgical Periodontal Treatment With Adjunctive Use of Lactoferrin Contained in Toothpaste and Mouthwash: 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 Plaque Index (Silness and Loe, 1964)
研究概览
简要总结
The aim of the study is to assess the effect of lactoferrin in LBC complex 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 the effect of lactoferrin in LBC complex 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 Trial group, in which patients will perform home oral hygiene with Emoform Glic toothpaste + mouthwash twice a day the Control group, in which patients will perform home oral hygiene with Emoform Glic toothpaste twice a day.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 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 Plaque Index (Silness and Loe, 1964)
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 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 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 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 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 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 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 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