NCT07494747招募中不适用
Benchmark Controlled Evaluation of the Effect of a Cosmetic Product in Improving Gums Condition - in Use Test Under Dentist Control
Lacer S.A.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
The goal of this study is to learn if a toothpaste works to alleviate gingivitis in adults. It will also learn about the safety of the product. The main question it aims to answer is:
• Does the toothpaste help to improve signs of gingivitis? Researchers will compare gingivitis toothpaste to a regular toothpaste to see if it works to improve gingivitis.
Participants will:
- Use assigned toothpaste daily for 4 weeks
- Visit the clinic on the established days during 4 weeks for check-ups and evaluation
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male and female subjects (with no specific repartition)
- •Subjects of Caucasian ethnicity
- •Subjects aged between 18 and 65 years (extremes included)
- •Subjects clinically showing moderate gums inflammation (gingivitis grade II, in particular all gingival scores for the mean should be between 1.75 and 2.3, according to Löe and Silness gingival scoring system), in particular:
- •40% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
- •60% of them with generalized gingivitis (>30% of evaluated sites with bleeding) Repartition to be respected in both study groups.
- •Subjects with dental plaque (total plaque score at inclusion ≥2)
- •Subjects registered with the national health service
- •Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
- •Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
- •Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements
- •Subjects who commit not to change their daily routine or lifestyle during the study
- •Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
- •Subjects informed about the test procedures who have signed a consent form and privacy agreement
排除标准
- •Subjects who do not meet the inclusion criteria
- •Smokers subjects
- •Subjects planning toothcare during the study period
- •Subjects using dental apparatus or using dental prosthesis, with generalized tooth recession, with presence of caries, with dental abscess or signs of periodontitis (periodontal probing depth >3mm) or active periodontitis
- •Subjects using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period
- •Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study
- •Subjects participating or planning to participate in other clinical trials
- •Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- •Subjects that have food intolerances or food allergies to ingredients of the study product
- •Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
- •Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
- •Subjects admitted to a health or social facility
- •Subjects planning a hospitalization during the study
- •Subjects not able to be contacted in case of emergency
- •Subjects deprived of freedom by administrative or legal decision or under guardianship
- •Subjects who have or have had a history of alcohol or drug addiction
- •Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
- •Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Extrinsic Tooth Whitening Evaluation of a Whitening ToothpasteNCT07428603Church & Dwight Company, Inc.118
已完成
不适用
Evaluation of Toothpaste Effect in Volunteers With Dental SensitivityNCT07593755Lacer S.A.71
尚未招募
3 期
Efficacy of a Toothpaste in Reducing Plaque, Gingivitis, and Gingival BleedingPlaque, DentalGingivitisNCT07499115Colgate Palmolive90
尚未招募
不适用
A Study Comparing Moringa Oleifera Mouthwash With Chlorhexidine And Salt water Concentration To Check Anti Plaque and Anti Gingivitis Effect in Gingivitis PatientsCTRI/2024/08/072097Dr Snigdha Kandukuri36
尚未招募
2/3 期
A Study of Kasisadi Churna Pratisaran Along With Madhu and Chlorhexidine Gluconate 1 % Gel in The Management of Sheetad W.S.R. to GingivitisCTRI/2024/03/063433Government Ayurveda College and Hospital100