Levels of IL-1β, PGE2, and MMP-8 in Saliva After the Use of Nigella Sativa Toothpaste in Indonesian Army Soldiers With Gingivitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in salivary IL-1β levels.
研究概览
简要总结
This study evaluated the effects of Nigella sativa toothpaste on salivary inflammatory biomarkers (IL-1β, PGE2, and MMP-8) in Indonesian Army personnel with gingivitis. The aim was to determine whether the toothpaste could reduce inflammatory marker levels associated with gingival inflammation.
详细描述
Gingivitis is an inflammatory condition of the gingiva that is commonly associated with elevated levels of inflammatory biomarkers in saliva. Nigella sativa has been reported to possess anti-inflammatory, antioxidant, and immunomodulatory effects, making it a potential adjunct in gingival inflammation management.
This study investigated the effect of Nigella sativa toothpaste on the salivary levels of IL-1β, PGE2, and MMP-8 in Indonesian Army personnel diagnosed with gingivitis. Saliva samples were collected before and after the intervention period. Biomarker concentrations were analyzed to assess the clinical and biochemical response to the use of Nigella sativa toothpaste. The study aimed to determine whether this herbal-based toothpaste could reduce inflammatory biomarkers and provide benefits in managing gingivitis.
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
- Double (Participant, Investigator)
盲法说明
This is a double-blind study where both the participants and the investigators are unaware of the group assignments. The treatment group received toothpaste containing 3% Nigella sativa, while the control group received a placebo toothpaste that was identical in appearance and packaging to ensure masking.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Indonesian Army (TNI) soldiers from the 202 Tajimalela Mechanized Infantry Battalion.
- •Diagnosed with gingivitis and periodontitis.
- •Aged 18-50 years.
- •Minimum of 20 teeth (excluding third molars).
- •Bleeding on Probing (BoP) score of ≥ 10%.
排除标准
- •Subjects who do not meet the inclusion criteria or are unwilling to provide written informed consent.
研究组 & 干预措施
Experimental Group: Nigella sativa Toothpaste
Participants in this group used toothpaste containing 3% Nigella sativa extract twice daily for three months, along with standardized oral hygiene education, to evaluate its effect on salivary inflammatory biomarkers.
干预措施: Nigella sativa toothpaste (Drug)
Control Group: Placebo Toothpaste
Participants in this group used a placebo toothpaste identical in appearance and taste but without Nigella sativa extract twice daily for three months, along with standardized oral hygiene education, as a comparison group.
干预措施: Placebo toothpaste (Drug)
结局指标
主要结局
Change in salivary IL-1β levels.
时间窗: Baseline and 3 months of daily toothpaste use
Measuring the concentration of Interleukin-1 beta (IL-1β) in saliva samples using the enzyme-linked immunosorbent assay (ELISA) method to evaluate inflammatory response.
Change in salivary PGE2 levels
时间窗: Baseline and 3 months of daily toothpaste use.
Measuring the concentration of Prostaglandin E2 (PGE2) in saliva samples using the enzyme-linked immunosorbent assay (ELISA) method to evaluate the reduction of inflammatory mediators.
次要结局
未报告次要终点
研究者
Yonathan Stiawan
Resident Department of Periodontology
Universitas Airlangga