Effect of Miswak and Miswak Extract on Oral Malodor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).
研究概览
简要总结
The aim of this experiment is to investigate the effect of Miswak on oral malodor and to determine whether this effect -if present- is the result of the mechanical action of Miswak or the chemical effect of its extract
详细描述
The study was designed as a randomized, parallel group clinical trial with one control and two test groups. The efficacy of each modality was evaluated by comparing the oral malodor indicators before use with those after 15 minutes (masking effect) and 7 days (therapeutic effect) of use. Three indicators for oral malodor were recorded; Organoleptic scores (OLS), Self-assessment of oral malodor, and the level of volatile sulfur compounds (VSC) measured by a breath checker device.
Ethical committee approval was obtained from the research center in Riyadh Colleges of Dentistry and Pharmacy (FUGRP/2013/114) prior to conducting of the study.
Between March and December 2014, screening of volunteered 212 female dental students aged 18-35 years was carried out. Preliminary interview and clinical examinations were done for all volunteers to select the sample according to the study inclusion and exclusion criteria. To be included in the study, the participants should report that they suffered from bad oral malodor and also should have an organoleptic score of 2 or above. Total of 167 interviewed subjects were excluded from the study for not fulfilling the eligibility criteria and a final sample size of 45 volunteers who have satisfied the criteria were selected in the study. The objectives of the study were fully explained and an informed written consent was obtained to participate in the study.
One week before the baseline readings all the 45 participants received instructions to avoid eating spicy foods, garlic and onions 2 days prior to the assessment. All participants were instructed to maintain their current oral hygiene regime.
The included participants (N=45) were randomly divided into 3 groups. (Group ME): 15 participants were asked to rinse with 50% Miswak extract mouth wash (5ml) twice a day for 7 days. Each participant was given a determined volume of the mouth wash and a marked scoop for the prescribed dose. Compliance of the participants was checked by measuring the remaining volume in the bottle during the second visit.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •the participants should report that they suffered from bad oral malodor
- •organoleptic score of 2 or above
排除标准
- •current systemic diseases or medical treatment
- •active caries or any faulty restorations
- •acute sinusitis or oro-pharyngeal infection
- •chronic periodontitis
- •pregnancy
- •breast feeding
- •eating very spicy food
- •use of antibiotic during the last two months before the start of the study
结局指标
主要结局
Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).
时间窗: After the first use of the prescribed method by 15 minutes, and after 7 days of use
The Organoleptic scores were obtained by a calibrated judge who first tested her ability to detect and distinguish odors even at low concentrations using the Smell Identification Test (Sensonics Inc., Haddon Heights, NJ, USA). To obtain the score, the patient was asked to close her mouth for approximately 3 minutes while breathing only from the nose. Then he/she was asked to release air from the mouth slowly. The judge kept a distance of about 10 cm between her nose and the patient's mouth to determine the score based on the intensity of the odor. The intensity ratings of 0 to 5 score was used where Score 0 stands for "No odor present", score 1 stands "barely noticeable odor", score 2 stands "slight but clearly noticeable odor", score 3 stands "moderate odor", score 4 stands "strong offensive odor" and a Score 5 stands "extremely foul odor".
次要结局
- Volatile Sulfur Compound Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect)(After the first use of the prescribed method by 15 minutes, and after 7 days of use)
- Self-assessment of Mouth Odor After 7 Days of Use(After 7 days of first use)
研究者
Mohammad Ramadan Rayyan
Assistant professor
Riyadh Colleges of Dentistry and Pharmacy