Changes in Streptococcus Mutans Colonization With Different Oral Hygiene Protocols in Adult Patients With Fixed Orthodontic Appliance:A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in amount of Streptococcus mutans colonization
研究概览
简要总结
Fixed orthodontic appliances increase the rate of plaque accumulation around orthodontic brackets and gingival margins. It was also found that the amount of plaque accumulation and S.mutans level around banded orthodontic appliances is much higher than unbanded appliances.appliances. This increases the importance of regular use of conventional tooth brushing with or without mouthwash for better control of plaque accumulation. Different studies had been conducted to compare the effect of different mouthwashes on plaque accumulation and rate of different bacterial colonization. Among which is Chlorhexidine mouthwash that showed highest antiseptic effect.
S. mutans bacteria are the main reason for the formation of plaque and dental caries associated with the use of fixed braces in 30-70% of patients. It also causes the appearance of white spot lesions on the teeth during and after fixed orthodontic treatment. Therefore, it is necessary to find solutions to overcome the occurrence of these effects resulting from the use of fixed braces, which usually makes it difficult for the accessing of various cleaning tools to these narrow places around the orthodontic brackets. Therefore, it is necessary to find an effective and easy way to clean the teeth that guarantees the safety of the patient's teeth during and after orthodontic treatment.Although mechanical plaque removal is very effective way in controlling amount of plaque accumulation, it is not applicable for subsequent application in patients with fixed orthodontic appliance.
Streptococcus mutans is considered as the main colonizer in the multi-species plaque biofilm. Studies found that as early as one week after bonding of fixed orthodontic appliances, significant changes occurred in the oral microbiota forming microbial plaque at the metal surfaces and the adjacent tooth surface.
The aim of this study is to compare the effect of three different oral hygiene protocols on the amount of Streptococcus mutans colonization in adult patients with fixed orthodontic appliance.
The null hypothesis is that there is no difference on the amount of Streptococcus mutans colonization between using combined tooth brushing, interdental brushing and mouthwash than using tooth brushing and interdental brushing in comparison to tooth brushing alone in adult patients with fixed orthodontic appliance.
详细描述
The study will take place in the clinic of the Orthodontic Department at the Faculty of Oral and Dental Medicine, Cairo University. The recruited sample will be from the Egyptian population. The principal investigator will recruit the patients according to planned eligibility criteria from the clinic of Orthodontic Department, Faculty of Dentistry, Cairo University. Screening of patients will continue until the total number (27 patients) of participants for the study is collected.
Principal investigator will fill a medical history questionnaire for every patient to exclude the presence of any systemic condition interfering with orthodontic treatment.
Proper examination of the oral structures is needed to identify caries, fracture or missing teeth.
Principal investigator will be carefully examining gingival tissues for any gingivitis, periodontitis, recession or lesions.
Principal investigator will check the potential patient to fulfill the inclusion criteria. Then will ask every participant to sign an informed consent about the study. Full set of records (study models, lateral cephalometric radiographs, photos) will be taken by the principal investigator for every patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.
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, Outcomes Assessor)
盲法说明
Blinding of the operator: Blinding will not be possible for the operator during the application interventions and during the follow up visits as he will be responsible for recruitment of sample, giving instruction about different hygiene measures that will be used by intervention/control group and follow up of patients collecting samples for that will be used in analysis.
Blinding of the outcome assessors: It is a single blinded study, the outcome assessors only will be blind. The patients name will be sealed from pre and post samples. Then assessor will carry on, blindly and independently, the measurements and analysis of the study.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adult patients with age range 18-30 years old.
- •Good to fair oral hygiene indicated by healthy non-inflamed gingiva and absence of carious lesions at the time of recruitment.
- •Full permanent dentition (except third molars).
- •Mild to moderate crowding.
- •Lack of using any mouth rinse for at least 1 month before the initiation of the study, and revealing no sign of sensitivity to mouthwashes.
排除标准
- •Presence of any systemic or infectious diseases.
- •History of antibiotic or hormonal therapy within the past 6 months prior to orthodontic treatment.
- •History of smoking.
- •History of professional cleaning (scaling) within the past 3 days prior to sample collection.
- •Presence of major untreated dental conditions such as untreated carious lesions at baseline.
研究组 & 干预措施
Intervention group 1
Fluoride-based toothpaste is used for tooth-brushing beside using interdental brushes.
干预措施: Interdental brush (Device)
Intervention group 1
Fluoride-based toothpaste is used for tooth-brushing beside using interdental brushes.
干预措施: Fluoride-based toothpaste (Other)
Intervention group 2
Chlorhexidine mouthwash is added to the previous oral hygiene protocol being used beside fluoride-based toothpaste and interdental brushes. CHX mouthwash is used by patients according to the manufacturer's instructions 15 min after tooth-brushing: 5 mL of 0.2% CHX was applied for 60s in the morning and at bedtime. The patients will be instructed not to consume any liquid or food at least 30 min after using the prescribed mouthwash. All patients are asked to bring the mouthwash bottle, so we could determine patient compliance based on how much liquid was left.
干预措施: Interdental brush (Device)
Intervention group 2
Chlorhexidine mouthwash is added to the previous oral hygiene protocol being used beside fluoride-based toothpaste and interdental brushes. CHX mouthwash is used by patients according to the manufacturer's instructions 15 min after tooth-brushing: 5 mL of 0.2% CHX was applied for 60s in the morning and at bedtime. The patients will be instructed not to consume any liquid or food at least 30 min after using the prescribed mouthwash. All patients are asked to bring the mouthwash bottle, so we could determine patient compliance based on how much liquid was left.
干预措施: Fluoride-based toothpaste (Other)
Control group
Regular tooth-brushing is carried out using fluoride-based toothpaste supplied only.
干预措施: Fluoride-based toothpaste (Other)
Intervention group 2
Chlorhexidine mouthwash is added to the previous oral hygiene protocol being used beside fluoride-based toothpaste and interdental brushes. CHX mouthwash is used by patients according to the manufacturer's instructions 15 min after tooth-brushing: 5 mL of 0.2% CHX was applied for 60s in the morning and at bedtime. The patients will be instructed not to consume any liquid or food at least 30 min after using the prescribed mouthwash. All patients are asked to bring the mouthwash bottle, so we could determine patient compliance based on how much liquid was left.
干预措施: Chlorhexidine mouthwash (Combination Product)
结局指标
主要结局
Change in amount of Streptococcus mutans colonization
时间窗: T0: pre-bonding. T1: 1 month after bonding.
Measure the difference in the amount of Streptococcus mutans colonization in adult patients with fixed orthodontic appliance with/without using chlorohexidine mouthwash. Samples will be collected at fixed timelines pre and during orthodontic treatment.
次要结局
- Change in plaque index score(T0: pre-bonding. T1: 1 month after bonding.)
研究者
Mohamed Abdelsalam Ahmed Abdelsalam Elbanna
Master candidate
Cairo University