A Prospective, Open Label, Randomized Control Trial to Study the Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- ICDAS score of the white spot lesion.
研究概览
简要总结
Dental caries is a decay process that breaks down the tooth. The earliest clinical signs of active dental caries is seen as 'white spot lesions' (WSLs). WSLs causes porosity below the tooth surface as a result of demineralization that gives the lesion a milky white appearance.
Many WSLs persevere even a decade after orthodontic appliance removal and remain a cosmetic problem. After removal of fixed appliances, a considerable improvement of WSLs can be seen during the first 6-24 months, but the degree of improvement varies between individuals.
Two common bacteria in dental plaque causes caries: Streptococcus mutans (SM) and Lactobacillus acidophilus (LA) in the plaque contributes to the initiation and progression of caries, respectively.
A major strategy suggested to deal with existing WSL after debond is to facilitate remineralisation using remineralising agents that contain fluoride. This can be from daily use of fluoridated toothpastes or having additional dose of fluoride application. Certain agents also contain casein phosphopeptide-stabilize amorphous calcium phosphate (CPP-ACP) that is believed to have an antibacterial and buffering effect on plaque and interfere the growth and adherence of bacteria.
详细描述
Rationale of the study :
Currently there is insufficient evidence on the most effective regime of fluoride application to regress post orthodontic WSLs and how it affects the quality and quantity of oral microbial flora.
The study aims to determine the effect of different remineralizing agents on white spot lesions and dental plaque of post-orthodontic treatment patients.
The objectives are:
- To compare the tooth surface changes (based on ICDAS, optical changes and patient perception) of white spot lesion treated with different remineralizing agents during orthodontic retention
- To compare the bacterial count (including streptococcus and lactobacillus) in subjects with white spot lesions treated with different remineralizing agents during orthodontic retention
- To compare the salivary profile (flow rate, Ph, buffering capacity) in subjects with white spot lesion treated with different remineralizing agents during orthodontic retention
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
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects on multibracket fixed appliance treatment
- •Subjects with 2 or more bracketed surfaces with labial subsurface WSLs from
- •upper right permanent canine (13) to upper left permanent canine (23) with an ICDAS II score of 1 and 2 will be selected.
- •Indicated for thermoform or vacuum formed retainers on the upper arch.
排除标准
- •Systemic diseases or any physical anomalies.
- •Subjects with intention to move out from Klang Valley area for the next 1.5 years.
- •Periodontal diseases (pocket depth of more than 3mm).
- •Severe fluorosis or any enamel abnormalities.
- •Antimicrobial agents or antibiotic therapy within the past 3 months.
- •Orthognathic surgery cases, cleft lip and palate.
- •Single arched lower fixed orthodontic treatment.
- •Milk protein and benzoate preservatives (a common preservatives) allergies.
结局指标
主要结局
ICDAS score of the white spot lesion.
时间窗: 18 months
Changes in WSL measured based on ICDAS score : * 0 No evidence of caries * 1 Initial caries * 2 Distinct visual change in enamel * 3 Localised enamel breakdown due to caries with no visible dentine * 4 Underlying dark shadow from dentine * 5 Distinct cavity with visible dentine * 6 Extensive distinct cavity with visible dentine
Optical changes (refractive index) of the white spot lesion.
时间窗: 18 months
Changes in WSL measured in lesion depths (LD in μm).
Patient perception of the WSL
时间窗: 18 months
Patient will be given a set of questionnaires at every follow up visit to assess the 1. Compliance to the remineralizing agent application 2. Perception on the WSL The perception will be based on the Likert scale
Dental plaque total bacterial count, Streptococcus count, Lactobacillus count.
时间窗: 18 months
Plaque samples will be collected with sterile swabs from the enamel surface of each tooth with the identified WSL to measure the bacterial count. The colony forming units of each plates is enumerated and the cfu/mL will be calculated
次要结局
- Salivary profile (salivary flow rate)(18 months)
- Salivary profile (buffering capacity)(18 months)
- Salivary profile (pH)(18 months)
研究者
Dr Wan Nurazreena Wan Hassan
Associate Professor, Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry
University of Malaya