Effect of Aloe Vera Mouthwashes on Plaque and Gingivitis Indices in Children (Clinical Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Effect of Aloe vera mouthwashes on plaque index
研究概览
简要总结
Prevention of dental problems by controlling plaque is the best solution to maintain oral health and prevent high cost of dental treatments. Home oral care is the cornerstone in removing plaque and therefore controlling tooth decay and gum disease. Unfortunately, complete plaque removal is difficult to achieve by mechanical methods alone.
For effective plaque control antiplaque agents such as chlorhexidine mouthwash is necessary. Chlorhexidine has shown distinct advantage, but it has many side effects such as staining of the teeth and the tongue, altered taste sensation, and increased calculus formation often deters its use for long periods.
Recently the use of herbal mouthwashes is rising due to the widespread awareness that natural substances have less side effects and lower economic cost. Of various plant extracts used as a base for mouthwashes, aloe vera deserves a special attention as it has recently been introduced in dentistry after years of use in medicine field.
Many recent studies stated that aloe vera mouthwashes has shown efficiency in plaque control and prevention of gingivitis, but there is a need for more studies to determine the best protocols regarding concentration and frequency of its use. A review of the literature shows that there is no randomized controlled trials evaluating its efficiency in plaque control and prevention of gingivitis in children, which is the main purpose of this study.
详细描述
The crossover design will be adopted in this study, i.e. the three types of mouthwashes (experimental "aloe Vera", positive control "chlorhexidine", negative control "placebo") will be utilized for all participants, with an equal (5) days application period for each type of mouthwashes and a wash-out period of (12) days between each type to ensure the elimination of the effects of a mouthwash before moving to the next one.
The evaluation areas selected for the study comprised the central maxillary incisors and the first maxillary molars.
A special plaque guard will be fabricated to cover the evaluated teeth and their gingival margins, this plaque guard will prevent plaque removal of the evaluated teeth and facilitate localized plaque accumulation and the resultant gingivitis if any.
At the start of the study, all participants will be instructed on how to brush their teeth properly and continue their regular oral hygiene.
All subjects will be instructed to wear the plaque guards every time they cleaned their teeth, so that they will not brush the maxillary incisors and the maxillary first molars. This phase "the accumulation phase" will last for 3 days, and then the subjects will be recalled to assess the difference in plaque accumulation on the 5th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient ages between (8 - 12) years.
- •Healthy children without any systemic medical conditions.
- •Good oral health (no manifestations of oral diseases on the mucous membranes).
- •The presence of the maxillary first permanent molars and the maxillary central incisors.
- •No caries on the buccal and lingual surfaces of the teeth.
- •Cooperative children (positive or definitely positive on Frankl's behavior rating scale).
- •The patient has the physiological ability to use the mouthwashes, This will be confirmed by asking the child's parent first and then test his/her ability to rinse with water before being enrolled in the study.
排除标准
- •Children with systemic medical conditions.
- •Patients undergoing current dental or orthodontic treatment.
- •Patients who used any other mouthwash during the study period or were given antibiotic therapy within 2 weeks before starting the study or corticosteroids within 30 days before starting the study.
- •Patients who use removable prosthetic or orthodontic appliances.
- •Patients who have gingival pockets more than (3) mm or advanced gingival diseases.
- •Fluorescent patients.
- •Patients who have a sensitivity story for any element of the mouthwashes used in the study.
- •Patients who underwent an extraction within two weeks of starting the study.
- •Patient lack of commitment toward follow-up appointments.
研究组 & 干预措施
Aloe Vera mouthwash
plaque accumulation and gingivitis will be evaluated before and after giving aloe vera mouthwash by studying plaque, gingival and bleeding indices.
the plaque will be accumulated for 3 days "accumulation phase" before applying aloe vera mouthwash for 5 days "rinsing phase".
干预措施: Aloe Vera mouthwash (Drug)
Chlorhexidine mouthwash
plaque accumulation and gingivitis will be evaluated before and after giving chlorhexidine mouthwash by studying plaque, gingival and bleeding indices.
the plaque will be accumulated for 3 days "accumulation phase" before applying chlorhexidine mouthwash for 5 days "rinsing phase".
干预措施: Chlorhexidine mouthwash (Drug)
Placebo mouthwash
plaque accumulation and gingivitis will be evaluated before and after giving placebo mouthwash by studying plaque, gingival and bleeding indices.
the plaque will be accumulated for 3 days "accumulation phase" before applying placebo mouthwash for 5 days "rinsing phase".
干预措施: Placebo mouthwash (Drug)
结局指标
主要结局
Effect of Aloe vera mouthwashes on plaque index
时间窗: before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)
this variable will be measured by calculating the difference between the index studied at the beginning and end of the experimental phase, to evaluate children's oral health and know the probability to have caries later.
Effect of Aloe vera mouthwashes on gingival index
时间窗: before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)
this variable will be measured by calculating the difference between the index studied at the beginning and end of the experimental phase, to evaluate children's gingival health and know the probability to have gingivitis later.
Effect of Aloe vera mouthwashes on gingival bleeding index
时间窗: before accumulation phase (at the 1st day), before rinsing phase (at the 3rd day) and after rinsing phase (at the 8th day)
this variable will be measured by calculating the difference between the index studied at the beginning and end of the experimental phase, to evaluate children's gingival health and know the probability to have gingivitis later.
次要结局
- the level of receptivity and discomfort and side effects of the Aloe vera mouthwashes.(at the end of each mouthwash experimental phase (8th day))