Aloe Vera and Chlorhexidine as Preventive Oral Antiseptics Against the Appearance of Traumatic Oral Ulcers in Patients With Fixed Orthodontics: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Prevalence of traumatic oral ulcers
研究概览
简要总结
The development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. The use of chemical agents such as CHX, although it has proven to be useful in these patients, but has the disadvantage of having side effects such as staining, even restricting its use during treatment.
The objective of this study was to determine the efficacy of Aloe vera gel at 80% compared to 0.12% Chlorhexidine gel to alleviate the effects derived from any orthodontic treatment, such as gingival inflammation and hyperplasia and friction or ulcerations. of traumatic oral mucosa-derived from treatment in patients after cementation with metal brackets in the two arches. A total of 140 patients between the ages of 10 and 55 who were randomized and assigned in the two study groups treated with Aloe vera gel versus the conventional Chlorhexidine gel with a sample of 70 subjects in each group participated.
The index of gingival inflammation, plaque index, as well as the simplified hemorrhage index, were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have just begun orthodontic treatment after bracket cementation.
- •Be willing and have signed the informed consent.
- •Presence of cemented metal brackets throughout the upper and lower arches.
- •Presence of good oral health: dental, periodontal and soft tissue
排除标准
- •Allergic or who have suffered adverse reactions to Chlorhexidine or Aloe Vera.
- •Pregnant, since they are not claimants of fixed multibrackets appliances.
- •Presence of auxiliary extraoral appliances during the treatment that may cause additional injuries.
- •Under 11 years old.
研究组 & 干预措施
Clorhexidine
- Clorhexidine Gel (LACER®, Barcelona, Spain) 0.12%, application 2 times / days for 1 month. The gel will be applied two times/day each 12 hours to the gingiva and mucosa.
干预措施: Antiseptic clorhexidine gel (Lacer, Barcelona, Spain) (Drug)
Aloe Vera
- 80% Aloe vera gel, application 2 times / day for 1 month
Master formula of 80% aloe vera gel Aloe Vera extract, obtained from the central part of the caudal leaves of plants with more than 8 years of life, eliminating its bark. Formulated with carbopol, hydrophilic crosslinked polymer of acrylic acid and vitamin C. The mixture is presented in containers that serve as a container for preparation and will be dispensed in the canister format with applicator tube.
干预措施: Master formula of aloe vera gel 80% (Drug)
结局指标
主要结局
Prevalence of traumatic oral ulcers
时间窗: 30 days
The patient will attend his scheduled appointment for bracket cementation. Before cementing, we will complete the clinical history (frequency of brushing, smoker or non-smoker, age, sex) aided by intraoral photographs, always collected in the same order according to protocol and by the same researcher. After the cementation, the patient will be included in the study in a random way in the corresponding group. One month after cementing and coinciding with the periodic visit of the patient, the presence / absence of friction or traumatic ulcers will be evaluated.
次要结局
- Prevalence of gingival inflammation(30 days)
- Prevalence of gingival bleeding(30 days)
研究者
Mario Pérez Sayáns
Principal investigator
University of Santiago de Compostela