Assessment of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Treatment of Periodontitis, Compared to Placebo and 0.2% Chlorhexidine. A Randomised Controlled Clinical Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Plaque index
研究概览
简要总结
Assessment of the efficacy of BMG0703 in the treatment of periodontitis and control of supragingival plaque, compared to Chlorhexidine and a placebo product
详细描述
The enrolled subjects will be examined and treated by specialized medical personnel.
Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
Next, subjects will be divided into three groups: after the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with the test product, active comparator or placebo, with the aid of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of the product (test, comparative or placebo) will then be given to the patient who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
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
The products will be packaged in such a way that they are not recognizable either by the operator or by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator on the basis of the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.
The data will be collected in pseudonymised form and inserted into a dedicated database in order to carry out the statistical analysis provided.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of periodontitis with pockets between 3 and 7 mm
- •Acceptance of informed consent
排除标准
- •subjects suffering from HIV
- •subjects suffering from hepatitis
- •serious systemic diseases preventing the use of specific dental therapies
- •acute and/or chronic infectious pathologies
- •inability to provide consent
- •use of topical or systemic drugs
- •inability to follow post-intervention hygiene instructions
研究组 & 干预措施
Hydrogen Peroxide and Hyaluronic acid (BMG0703)
Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of BMG0703 will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
干预措施: Hydrogen Peroxide and Hyaluronic acid filming formulation (Drug)
Chlorhexidine 0.2%
Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of Chlorhexidine 0.2% will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
干预措施: Chlorhexidine 0.2% (Drug)
Placebo product
Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of the placebo product will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Plaque index
时间窗: 0, 3, 7, 30 days
Subjects will undergo the measurement of plaque index according to Silness J \& Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered. Data will be collected based on four possible clinical conditions: Code 0: absence of plaque; Code 1: presence of plaque not visible to the naked eye but evidenced by the periodontal probe passage; Code 2: presence of plaque at the level of the gingival margin; Code 3: abundant presence of plaque at the level of the gingival margin and/or the rest of the dental surface. Higher score means worse outcome The sum of the values of the four surfaces examined, divided by the very number of surfaces, will give the plaque and bleeding index value for each individual tooth. The sum of the indices of each examined tooth divided by the total number of teeth examined will indicate the overall plaque and bleeding index of the subject at that time.
Change in Bleeding index
时间窗: 0, 3, 7, 30 days
Subjects will undergo the measurement of bleeding index according to Silness J \& Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered. Data will be collected based on four possible clinical conditions: Code 0: absence of bleeding during probing depth measurement; Code 1: absence of bleeding during probing depth measurement, presence of redness and oedema; Code 2: presence of bleeding during probing depth measurement with redness and oedema; Code 3: spontaneous bleeding Higher score means worse outcome.
次要结局
- Change in Microbiological analysis(0,3,7,30 days)
研究者
Chiara Occhipinti
Professor
University of Milan