Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- gingival enlargement
研究概览
简要总结
Orthodontic appliances can affect changes in the relationships of members of the oral microbiome. Microbiome imbalance can result in oral infections and complicate treatment. The focus is on the microbiological profile of dental biofilm and its control. The effects of metals released by corrosion of alloys for oral use on the microbiome and the extent to which they modify the effectiveness of gingivitis therapy by mechanical and chemical control of biofilm will be investigated. Early and late colonizers of the tooth surface will be analyzed. The condition of gingiva will be assessed, and the results will show the specifics of biofilm and gingiva exposed and unexposed, and differences in the response of individual bacteria to therapy. Molecular biology techniques will be used to quantify the total bacterial biomass (16s rRNA) and the proportion of specific bacterial species within the dental biofilm.
详细描述
The aim is:
- to determine the clinical characteristics of gingiva of subjects not exposed to metals of dental alloys and exposed to metals
- characterization of microbiome of dental biofilm in subjects not exposed to metals of dental alloys and exposed to metals and to determine changes in the structure of dental biofilm due to exposure to metals
- examine the extent to which environmental influences modify the effectiveness of treatment of gingivitis by mechanical removal of biofilm and chemical control (chlorhexidine digluconate mouthwash (CHX))
- to examine the behavior of bacteria of early and late colonizers of dental biofilm after chemical control
- to analyze biofilm on metal and non-metal appliance
- to explore patient reported outcome measures Study design is a randomized controlled trial with 4 parallel groups: (I) fixed metal orthodontic appliance with regular oral hygiene, (II) fixed metal orthodontic appliance with CHX, (III) non-metal fixed orthodontic appliance with regular oral hygiene, and (IV) non-metal orthodontic appliance with CHX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Groups were labeled as I-IV, appliance is fixed on teeth and visible for both participants and care providers. Mouthwash is also visible. Outcome assessor does not know wether patient was in mouthwash group, but he sees the type of appliance. Microbiologist and statisticians are not aware of the group affiliation.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades >=3)
排除标准
- •neurodevelopmental disorders
- •intellectual disability
- •oligodontia
- •congenital craniofacial anomalies
- •orofacial clefts
研究组 & 干预措施
metal + OH
fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
干预措施: fixed metal orthodontic appliance (Device)
metal + OH
fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
干预措施: oral hygiene (Procedure)
metal + CHX
fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
干预措施: fixed metal orthodontic appliance (Device)
metal + CHX
fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
干预措施: Chlorhexidine mouthwash (Drug)
non-metal + OH
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
干预措施: fixed non-metal orthodontic appliance (Device)
non-metal + OH
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
干预措施: oral hygiene (Procedure)
non-metal + CHX
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
干预措施: fixed non-metal orthodontic appliance (Device)
non-metal + CHX
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
干预措施: Chlorhexidine mouthwash (Drug)
结局指标
主要结局
gingival enlargement
时间窗: 90 days (change from start to 2 months and 3 months after start)
Seymour index (thickness (scale 0=normal-2=thickening \>=3mm) + proportion of tooth crown coverage (scale 0=normal-3=papilla involving .2/3 of adjacent tooth crown half) on frontal teeth vestibular and oral in both jaws; scale 0-100), higher score means worse outcome
bacterial composition of dental biofilm
时间窗: 90 days (change from start to 2 months and 3 months after start)
bacterial ratio in dental biofilm (molecular biology analysis)
次要结局
- pH of biofilm(90 days (change from start to 2 months and 3 months after start))
- dental biofilm accumulation(90 days (change from start to 2 months and 3 months after start))
- extent of gingivitis(90 days (change from start to 2 months and 3 months after start))
- oral health-related quality of life(90 days (change from start to 2 months and 3 months after start))
研究者
Stjepan Spalj
Professor
University of Rijeka