Holistic Approach to Investigate Protective and Risk Factors for Dental Caries in Patients With or Without Diabetes Type 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- The extent of coronal dental caries
研究概览
简要总结
Background: Diabetes mellitus (DM) is well known for long-term complications to general and oral health. Periodontal disease has a bidirectional association with the development of type 2 diabetes (T2DM) (Mealey, 2006; Taylor, 2001; Demmer et el.,2008). However, current literature conflicts with regards to dental caries incidence in patients with T2DM (Sampaio, Mello and Alves, 2011).
Objective: To investigate potential protective and risk factors for dental caries among T2DM with vitamin D and HbA1c using clinical, salivary and microbial analyses.
Methods: This project is a case-control clinical study. The study will be conducted at Royal London Dental Hospital, Institute of Dentistry, Bart's Health NHS Trust, London, UK. This study will aim to recruit 182 participants in total with diabetes (type 2), aged ≥18 male or female and participants will be cross-matched with non-diabetes according to age and gender.
Each participant will undergo a baseline screening for around 60 minutes where all the following assessments will be carried out; Caries risk assessment (CAMBRA), Plaque index, International Caries Detection and Assessment System (ICDAS) and Laser fluorescence evaluator (SOPRLIFE®, Acteon, France) and Oral behavioural and sociodemographic background will be collected.
Prior to the clinical study, there will be a laboratory based study using extracted teeth. The aim of this ex-vivo study is to assess the autofluorescence variation in dental carious lesions and compare this with International Caries Detection and Assessment System (ICDAS).
详细描述
Research purpose:
The research question is individuals with Diabetes Mellitus type 2 (T2DM) is more prone to dental caries?
Several literature reviews point the lack of solid evidence clear association of the DM and dental caries (Ship, J.A., 2003; Taylor et al., 2004; Lamster, I.B., 2014; Garton et al., 2012; Leite et al., 2013).Also, a controversial result available of the epidemiology of dental caries among individuals with T2DM (Sampaio, Mello and Alves, 2011), besides limited knowledge about the biological explanation as seen with periodontal disease (Verhulst et al., 2019).Moreover, no study had a comprehensive evaluating of all potential caries risk factors. Thus this study developed a preliminary conceptual model in which 48 potential risk factors were identified and categorised into four domains: biological/intra-oral factors, medical factors, oral health behaviour, and sociodemographic factors.
All these potential factors will be evaluated and analysed through different appoaches; clinical, salivary, microbial analyses and patient questionnaire.
Recruitment process:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants may enter the trial if the following apply:
- •Participants who are male or female ≥ 18 years of age.
- •For the test group, they have been diagnosed with type 2 Diabetes
- •For the control group, participants who are not diagnosed with type 2 Diabetes
- •Particiapants having minimum one natural tooth
- •They are capable of giving informed consent
- •They have the ability to understand and speak English
- •They are able and willing to comply with all trial requirements
- •They are not participating in another dental trial
- •They are not diagnosed for cognitive defect due to mental illness, depression, Alzheimer's disease, or dementia.
- •No antibiotics, no steroidal and/or non-steroidal anti-inflammatory medication used during the last 3 weeks
- •Participants who are not pregnant and also not breastfeeding
- •Participations who are not in another dental study testing different dental products during the previous three months and during the study period
- •Participants who are not currently taking Vitamin D supplements
排除标准
- •- Participants may not enter the trial if ANY of the following apply:
- •Participants who are edentulous
- •Cognitive defect due to mental illness, depression, Alzheimer's disease, or dementia.
- •The presence of any hard or soft tissue tumours in the oral cavity
- •Patients undergoing chemo and/or radiation therapy
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Any condition, which in the opinion of the investigator, would preclude participation by the subject (such as cross-infection control risk)
- •Participants who are prescribed long-term systematic antibiotics
- •Participants who are pregnant and breastfeeding
- •Participations who are in another dental study testing different dental products during the previous three months and during the study period
- •Participants who had additional fluoride treatment in the past 6/3 months
- •Participants who are prescribed to use high fluoridated toothpaste
- •Participants who are currently taking Vitamin D supplements
结局指标
主要结局
The extent of coronal dental caries
时间窗: Initial screening
The extent of dental caries is investigated using well-establish scoring system called "International Caries Detection and Assessment System" (ICDAS)
The extent of root dental caries
时间窗: Initial screening
The extent of root dental caries is investigated using well-establish scoring system called severity index
次要结局
- Estimation of Cariogenic bacteria (Lactobacillus )(Initial screening)
- Estimation of buffer capacity(Initial screening)
- Estimation Spinnbarkeit(Initial screening)
- Measuring the vitamin D levels(Initial screening)
- Estimation of unstimulated saliva flow rate(Initial screening)
- Estimation of saliva electrolytes(Initial screening)
- Measuring the blood HbA1c(Initial screening)
- Dental caries risk levels(Initial screening)
- Estimation of Cariogenic bacteria (Mutans streptococci)(Initial screening)
- Estimation of Cariogenic bacteria (Actinomyces)(Initial screening)
- Estimation of total bacterial load(Initial screening)
- Estimation of pH(Initial screening)
- Estimation of stimulated whole saliva metabolic profile.(Initial screening)