The Effects of Theranovis Dental Gel in Patients With Gingivitis: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The aim of this randomized, blinded, controlled study is to compare the theranovis dental gel with a placebo product in order to determine whether an improvement in oral health can be achieved in patients with gingivitis.
详细描述
This study will be conducted at the Medical University of Graz and will include a total of 20 participants, divided into two groups (10 participants per group). One group will receive theranovis dental gel, while the other group will receive a placebo product. Participants will be randomly assigned to the groups using a randomization list created before the start of the study.
The dental gel should be applied with a manual toothbrush every morning and evening after toothbrushing, left in place for 30 seconds without swallowing, and then spat out without rinsing with water afterward.
Participation in the study is expected to last 8 weeks. Study-related procedures include a professional dental cleaning at baseline, assessment of baseline values and repeated measurements of these parameters every 2 weeks during the study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged over 18 years
- •At least 12 teeth per jaw (natural teeth, including restorations such as crowns and implants)
- •Smokers (less than 10 cigarettes per day)
- •Gingivitis with intact periodontium (probing depth ≤ 3.0 mm, bleeding on probing > 10%)
- •Gingivitis with intact periodontium (probing depth ≤ 4 mm, no bleeding on probing at these sites)
- •Periodontal screening index (PSI) up to grade 2
排除标准
- •Male and female participants under 18 years of age
- •Fewer than 12 teeth per jaw
- •Individuals not capable of giving informed consent
- •Individuals with hypersensitivity or allergies to any of the study product ingredients
- •Patients with periodontitis
- •Patients with non-plaque-induced gingivitis
- •Periodontal screening index (PSI) grade 3 or higher
- •Current antibiotic prophylaxis