Clinical Evaluation of a Mouthwash Containing Malva Sylvestris Extract and Its Role in Reducing Oral Biofilm and Gingival Inflammation. A Randomized, Triple Masked Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Basic periodontal examination
研究概览
简要总结
Background: For centuries, plants (and / or their products) were the only resource available for the prevention and treatment of many diseases. However, its indiscriminate use without phytochemical, pharmacological and toxicological knowledge is a concern for health. The Malva sylvestris (family Malvaceae and popularly known as Malva) is mentioned in the literature as an ethnopharmacological medicine with anti-inflammatory, antimicrobial, wound healing and other properties. For this reason, M. sylvestris presents empirical indications in dentistry, mainly in the treatment of periodontal diseases (gingivitis and periodontitis), which are highly prevalent worldwide. However, scientific evidence is scarce in information that supports the biological properties and clinical benefits attributed to it.
Objective: The objective of this study was to evaluate the effect of a mouthwash based on Malva sylvestris in the control of gingival inflammation and dental biofilm.
Methods: A randomized, three-group, triple-masked clinical trial was designed. Patients from the Center of Dental Clinics of the Austral University of Chile participated with a diagnosis of gingivitis and chronic periodontitis. They were distributed randomly in three study groups: 1. Chlorhexidine mouthwash 0.12%; 2. Mouthwash with extract of M. sylvestris and 3. Mouthwash control group. The indications and dosage were identical for all groups: rinse with 10 ml, for 1 minute, every 12 hours for 7 days. The gingival index and plaque control record were recorded at the beginning and end of the follow-up period (7 days). The results obtained between the groups were compared through normality test and group analysis (ANOVA/Mann-Whitney/Dunnet p <0.05).
Results: The pharmacological potential of M. sylvestris was determined in the reduction of the plaque control record and gingival index.
详细描述
Design:
It´s designed a randomized clinical trial of three parallel groups, triple masking. The study and informed consent document were reviewed and approved by the Comité Ético Científico of Servicio de Salud Valdivia (ORD 181/2017) and written according to the CONSORT (EQUATOR Network) writing guidelines.
Population:
The participants were selected from the Department of Oral and Periodontal Surgery of the Dental Clinic Center of the Universidad Austral de Chile (UACh) (Valdivia, southern Chile) during the months of October 2017 to December 2018.
Sample size:
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Each clinical record was coded by number, group and each group was assigned a color, which was stamped on the bottle of each mouthwash (bottles were of the same appearance).
The masking mechanisms through coding by number, group and color, ensured that the patients did not know the specific mouthwash they received; examiners E.A and A.N were limited only to assessing the clinical aspects; and the data analysis was performed with the database using numerical coding. Only researcher B.B was aware of the real assignment by color, with its corresponding study group and number.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Code equal of higher than 2 (Basic Periodontal Examination-BPE).
- •I or II ASA classification.
- •Without periodontal treatment on past three months.
排除标准
- •Acute infection
- •Dental trauma
- •Alveolar osteitis (Dry socket)
- •Elderly dependent patients
- •Orthodontic appliances
- •Antibiotic therapy
- •Analgesic therapy
- •Heavy smokers
- •Menstrual period
- •Pregnants
- •Lactating woman
研究组 & 干预措施
M. sylvestris mouthwash
using 10 ml, rinse for one minute, 1 time every 12 hours for 7 days.
干预措施: experimental group 10% mouthwash of M. sylvestris extract (Drug)
CHX mouthwash
using 10 ml, rinse for one minute, 1 time every 12 hours for 7 days.
干预措施: experimental group 10% mouthwash of M. sylvestris extract (Drug)
Placebo mouthwash
using 10 ml, rinse for one minute, 1 time every 12 hours for 7 days.
干预措施: experimental group 10% mouthwash of M. sylvestris extract (Drug)
结局指标
主要结局
Basic periodontal examination
时间窗: 7 days
The mouth is divided into sextants and using a WHO-standardized periodontal probe (Hu-FriedyⓇ), the probing of each tooth is performed in 3 points (mesial, medial and distal) by vestibular and lingual -palatal of each tooth, registering the highest value per sextant, according to the following coding: 0 (healthy tissue), 1 (positive bleeding, absence of periodontal pocket), 2 (presence of tartar, defective fillings, black area of the probe completely visible), 3 (black area of the probe partially visible, periodontal pocket of 3.5 - 5.5 mm), 4 (black area of the probe below the gingival margin, periodontal pocket greater than 5.5 mm).
Plaque control record
时间窗: 7 days
5 drops of Bacterial Plaque Revealing Solution (Caristop-Revelador DUAL TONE, MAVERⓇ) are applied and the patient is instructed to make movements with the tongue in such a way that it touches all dental surfaces in a time of 15 seconds . The vestibular, lingual and interproximal surfaces of all the teeth are then examined. To calculate the index, add the total number of dental surfaces with bacterial plaque, divide this number by the total number of surfaces present in the mouth and multiply by 100
Gingival index
时间窗: 7 days
With a WHO-standardized periodontal probe (Hu-FriedyⓇ), the buccal, lingual and interdental papillae marginal gingivae are probed, using a four-point scale from 0 (absence of inflammation) to 3 (severe inflammation)
次要结局
未报告次要终点