Adjunctive Use of Coenzyme Q10 and Probiotics to Improve Periodontal Health in Pregnant Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Dental Plaque Measured by the Plaque Index Score
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effectiveness of adjunctive coenzyme Q10 and probiotic supplementation (Limosilactobacillus reuteri Prodentis®) in improving periodontal health in pregnant women undergoing non-surgical periodontal therapy. Forty participants will be randomly assigned to two groups: the test group will receive professional oral hygiene every three months along with a coenzyme Q10-based toothpaste and daily probiotic supplementation; the control group will follow the same protocol without probiotics. The primary outcome is the reduction of the Plaque Index (PI), while secondary outcomes include Bleeding on Probing (BoP), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), gingival inflammation (MGI, PMGI), plaque distribution (PCR%, API), and gingival recession (R). The study duration is 6 months. The goal is to assess whether this combined therapy can promote a balanced oral microbiota and enhance periodontal health during pregnancy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between the 4th and 8th month of gestation
- •Age ≥ 18 years
- •Able to understand and communicate in Italian and/or English
- •Willing to provide written informed consent
- •Good compliance and willingness to follow study instructions
排除标准
- •Presence of cardiac pacemakers
- •Diagnosed psychological, neurological, or psychiatric disorders
- •Ongoing oncological therapy
- •Use of bisphosphonates within the last 12 months
- •Poor motivation or low compliance
- •Substance abuse (drugs or alcohol) or lifestyle incompatible with study requirements
研究组 & 干预措施
Coenzyme Q10 Plus Probiotics
Participants assigned to this arm will undergo professional oral hygiene every three months and will follow a home-care regimen consisting of twice-daily use of a coenzyme Q10-based toothpaste combined with a daily probiotic supplement (Limosilactobacillus reuteri Prodentis®, 1 tablet per day) for 6 months. Additional hygiene tools include soft picks and a sonic toothbrush.
干预措施: Limosilactobacillus reuteri Prodentis® (Dietary Supplement)
Coenzyme Q10 Plus Probiotics
Participants assigned to this arm will undergo professional oral hygiene every three months and will follow a home-care regimen consisting of twice-daily use of a coenzyme Q10-based toothpaste combined with a daily probiotic supplement (Limosilactobacillus reuteri Prodentis®, 1 tablet per day) for 6 months. Additional hygiene tools include soft picks and a sonic toothbrush.
干预措施: Coenzyme Q10 Toothpaste (Other)
Coenzyme Q10 Only
Participants assigned to this arm will undergo professional oral hygiene every three months and will follow a home-care regimen consisting of twice-daily use of a coenzyme Q10-based toothpaste for 6 months, without probiotics. Additional hygiene tools include soft picks and a sonic toothbrush.
干预措施: Coenzyme Q10 Toothpaste (Other)
结局指标
主要结局
Change in Dental Plaque Measured by the Plaque Index Score
时间窗: Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3)
The Plaque Index (PI) Score will be recorded at four timepoints (baseline, 1 month, 3 months, and 6 months) to assess the amount of dental plaque accumulation. The primary endpoint is the change in PI from baseline (T0) to 6 months (T3), comparing the intervention group (coenzyme Q10 + probiotics) to the control group (coenzyme Q10 only). The index is measured by visually scoring the plaque on tooth surfaces using standardized criteria. The Plaque Index score ranges from 0 (no plaque) to 3 (abundant plaque), with higher scores indicating a worse outcome.
次要结局
- Change in Gingival Bleeding Measured by the Bleeding on Probing (BoP) Index(Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3))
- Change in Periodontal Pocket Depth Measured by the Probing Pocket Depth (PPD)(Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3))
- Change in Clinical Attachment Level Measured by CAL(Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3))
- Change in Gingival Inflammation Measured by the Modified Gingival Index (MGI)(Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3))
- Change in Interproximal Plaque Measured by the Approximal Plaque Index (API)(Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3))
- Change in Plaque Distribution Measured by Plaque Control Record (PCR%)(Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3))
- Change in Gingival Inflammation Measured by the Papillary Marginal Gingival Index (PMGI)(Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3))
- Change in Gingival Recession Measured by Clinical Examination(Baseline (T0), 1 Month (T1), 3 Months (T2), and 6 Months (T3))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia