Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Domiciliary Oral Hygiene.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in BOP - Bleeding on Probing (percentage)
研究概览
简要总结
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day
- Control group: home oral application of Biorepair Peribioma Toothpaste
Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months.
详细描述
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day
- Control group: home oral application of Biorepair Peribioma Toothpaste
Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months, the following indexes will be assessed: Probing Pocket Depth, Bleeding on Probing (percentage), Clinical Attachment Loss, Gingival recession, Plaque Control Record, Modified Gingival Index, Papillary Marginal Gingival Index.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
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 BOP - Bleeding on Probing (percentage)
时间窗: Baseline, after 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 PMGI - Papillary Marginal Gingival Index
时间窗: Baseline, after 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 CAL - Clinical Attachment Loss
时间窗: Baseline, after 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 PPD - Probing Pocket Depth
时间窗: Baseline, after 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 R - Gingival recession
时间窗: Baseline, after 1, 3 and 6 months.
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in PCR% - Plaque Control Record
时间窗: Baseline, after 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.
Change in MGI - Modified Gingival Index
时间窗: Baseline, after 1, 3 and 6 months.
Scoring criteria: * 0: normal * 1: mild inflammation (slight changes in color and texture, but not in all portions of gingival marginal or papillary) * 2: mild inflammation (slight changes in color and texture in all portions of gingival marginal or papillary) * 3: moderate (bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary) * 4: severe inflammation (erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration)
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia