EUCTR2008-000990-39-LV进行中（未招募）不适用
Reduction of the gingival inflammation by V0109 DI. Randomised, parallel groups, double blind study, V0109 DI versus placebo, in patients presenting gingivitis.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Will be eligible patients (male or female) who meet the following criteria:
- •- age between 18 and 45 years inclusive,
- •- negative urine pregnancy test at inclusion for woman of child bearing potential and using an efficient contraceptive (oral contraception, intrauterine device, tubal ligature) since at least 2 months before the screening and until 1 month after the end of the study,
- •- stable hormonal contraception since least 2 months before the screening visit and not start it during the study,
- •- be non smoker,
- •- have a minimum of 20 natural teeth ( excluding wisdom teeth) and good dental health (except gingivitis),
- •- have a toothbrush and toothpaste,
- •- have gingivitis (Gingival Index > or equal to 1,5),
- •- willing and able to understand and sign an approved Informed Consent Form,
- •- able to understand the protocol and to attend the control visits,
- •- registered with a social security or health insurance system if required by law.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Will not be included patients who have one of the following criteria:
- •* Criteria related to pathology
- •- periodontitis,
- •- history of periodontitis or acute necrotizing ulcerative gingivitis,
- •- history of severe medical or psychiatric disease/disorder which, in the judgement of the investigator, puts the patient « at risk » or is likely to modify the handling of the study drug,
- •- epilepsy,
- •- any coagulation disorder,
- •- hyposialia or asialia,
- •- caries with cavities and ill-fitting restorations,
- •- lichen planus,
- •- current signs or symptoms of mucosal tissue ulcerations, or canker sores,
- •*Criteria related to treatments
- •- currently undergoing orthodontic treatment,
- •- extensive interproximal restorations, crowns, bridges or implants,
- •- treatment within the six weeks preceding inclusion with either :·antibiotics·corticosteroids·non-steroidal anti-inflammatory drugs·immunosuppressive drugs, immunostimulant drug, antimitotic drug,
- •- start or change within the preceding month of any drug which could interfere with salivary flow: anticholinergic drug, atropine, scopolamine, quaternar amoniums, imipraminic antidepressives, sedative antihistamines, phenothiazines neuroleptics, disopyramide,
- •- treatment with any other topical product (i.e. mouthwashes, gels,…) which could interfere with the study treatment,
- •* Criteria related to the way of life
- •- Drinking excessive amounts of alcohol (more than 2 glass of wine (>2) per day or equivalent),
- •- history of drug addiction,
- •* Criteria related to the population
- •- female who is pregnant or breast feeding or not using contraception, or planning to become pregnant,
- •- participation to an other clinical trial in the previous month before the inclusion visit or during the study,
- •- patient who is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
- •- patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship,
研究者
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