Evaluation of IgY Antibody Effectiveness in Supportive Therapy of Periodontitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
研究概览
简要总结
Patients visiting National Hospital of Odonto-Stomatology for treating periodontitis used a food supplement (lozenge) containing chicken egg antibody (IgY) against Porphyromonas gingivalis gingipains as an adjunct to conventional scaling and root planing (SRP). After 8 weeks the patients were examined against. Parameters including probing depth (PD), bleeding on probing (BOP), number of P. gingivalis in periodontal pockets were evaluated and compared to the control group that had used placebo lozenges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with chronic periodontitis
- •had at least 2 interproximal site with pocket depth between 3 mm to 5 mm
- •nonsmokers with at least 20 natural teeth
- •bone loss and bleeding on probing
- •had not undergone periodontal treatments within 6 weeks before the study
排除标准
- •patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months
- •had allergy to egg proteins
研究组 & 干预措施
Gingipain IgY
Participants consume lozenges containing IgY against gingipains of Porphyromonas gingivalis
干预措施: lozenges containing IgY (Dietary Supplement)
Placebo IgY
Participants consume lozenges containing placebo IgY
干预措施: Placebo IgY (Dietary Supplement)
结局指标
主要结局
Effect of anti-gingipain IgY on probing pocket depth of subjects with chronic periodontitis
时间窗: 8 weeks
Outcome measurement is probing pocket depth (PD)
Effect of anti-gingipain IgY on bleeding on probing of subjects with chronic periodontitis
时间窗: 8 weeks
Outcome measurement is bleeding on probing (BOP)
次要结局
- Effect of anti-gingipain IgY on Porphyromonas gingivalis level of subjects with chronic periodontitis(8 weeks)