Efficacy of Multi-component Oral Hygiene Regimens in Patients Undergoing Non-surgical Periodontal Treatment: a Multicentered Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pocket depth (PD) reduction
研究概览
简要总结
The objective of this clinical study is to evaluate the efficacy of multi-component oral hygiene regimens as adjunctive to non-surgical periodontal treatment in patients with stage II periodontitis.
详细描述
This is a Phase III, multicenter, controlled, randomized, double-blind clinical trial with two parallel arms. A total of 100 participants, aged 30 to 70, diagnosed with stage II generalized periodontitis will undergo non-surgical periodontal treatment and be randomized to one of two at-home oral hygiene regimens. Participants will be monitored over a 12-month period to assess clinical periodontal parameters.
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)
盲法说明
All products will be covered with white over-wrapping in order to conceal product identity. The examining dentist and their staff will remain blinded to product assignments.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, between 30-70 years of age, inclusive.
- •Good general health. Minimum of 15 uncrowned permanent natural teeth (excluding third molars and crowns).
- •Clinical diagnosis of stage II generalized periodontitis.
排除标准
- •Periodontal treatment undergone 3 months before the beginning of the study. - Mucosal oral pathology.
- •Uncontrolled systemic chronic disease that may interfere with host response. - Use of anti-inflammatory and antibiotic within 3 months prior to the start of the study, scheduled to start such intake during the treatment phase, or use of therapeutic mouthwash within the last three months.
- •Need for antibiotic prophylaxis.
- •Participation in any other clinical study.
- •Pregnant, breastfeeding, or intended to get pregnant during the study.
- •Allergic to oral care products, personal care consumer products, or their ingredients.
- •Ongoing use of medications known to affect the gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine).
- •Current smokers and subjects with a history of alcohol or drug abuse. - Orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations.
研究组 & 干预措施
Test Group
Participants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen (Regimen I) consisting of a chlorhexidine mouthwash, stannous fluoride toothpaste, toothbrush, and floss for 3 weeks. Afterward, they switch to Regimen II consisting of a CPC/Zinc Lactate mouthwash, stannous fluoride toothpaste, toothbrush, and floss.
干预措施: Active Oral Hygiene Regimen (Combination Product)
Negative Control Group
Participants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen consisting of a fluoride placebo mouthwash, standard fluoride toothpaste, toothbrush, and floss for the duration of the study.
干预措施: Placebo Oral Hygiene Regimen (Combination Product)
结局指标
主要结局
Pocket depth (PD) reduction
时间窗: Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment
The distance measured between the gingival margin and the bottom of the gingival sulcus or the periodontal pocket, assessed at six sites per tooth using a calibrated periodontal probe.
次要结局
- Change in Bleeding on Probing (BOP)(Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment)
- Number of residual pockets(3 months, 6 months, 9 months, and 12 months post-treatment)
- Change in subgingival microbiological composition(Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment)
- Change in levels of immunological mediators in gingival crevicular fluid (GCF)(Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment)
- Change in Gingival Index (GI)(Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment)
- Change in Plaque Index (PI)(Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment)
- Clinical Attachment Level (CAL) gain(Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment)