The Effect of Chlorhexidine on the Oral Microbiome, Salivary Pellicle Proteins and Vascular Function in Individuals With Dental Erosion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Identification of salivary proteins via SDS-PAGE Electrophoresis:
研究概览
简要总结
Dental erosion happens when the teeth lose some of their parts because of acid from the things people eat and/or drink or even from stomach. It can make teeth hurt and become sensitive. The mouth has a protective shield called salivary pellicle that helps, and there are some special bacteria called Nitrate-reducing bacteria (NRB) that can be good for the mouth and heart. Eating some fruits and vegetables or drinking beetroot can make these bacteria thrive, which might help the heart and blood pressure. This study wants to see how administering chlorhexidine mouthwash affects the good bacteria in the mouth for people with healthy teeth and those with erosion. This study aims to find out if this mouthwash can change the saliva and bacteria in the mouth for the better, in people with both healthy teeth and those with dental erosion.
The proposed study is part of a PhD educational project and will be a double blind, randomised design, crossover trial for the effect of Chlorhexidine (CHX) mouthwash on healthy control and people with dental erosion (PwDE). This study aims to explore mouthwash's effect on oral microbiome recovery in WMS and salivary pellicle and its impact on blood pressure and arterial stiffness in healthy controls PwDE
详细描述
Upon consent being granted, several samples and measurements will be collected from the participant during this research study spanning over 15 visits. The proposed study will be a double blind, randomised design, crossover trial for the effect of CHX mouthwash on healthy control and PwDE. Two groups of participants are required for this study [healthy (n=12) and PwDE (n=12) groups] from volunteer participants from the university of Portsmouth (UoP) who have no signs of or reported medical problems (detailed protocol of recruitment attached). Based on power calculation, 14 individuals will be recruited for each group (healthy and PwDE groups) to account for a 14% drop-out rate.
Participants will be approached to volunteer for the study by the chief investigator and PhD researcher through word of mouth, emails via departmental staff lists, University of Portsmouth Dental Academy (UPDA) updates newsletter, UPDA department meetings and presentations about the study during the UPDA's journal club event. A participant information sheet (PIS) and consent form (see attached forms) will be distributed either via email or by handing out hard copies to those wishing to partake in the research. Participants who have returned their completed consent form will be invited to come to UPDA for further assessment of suitability (visit 1).
The participants who has agreed to take part in this research will be invited to attend the University of Portsmouth Dental Academy, Beatty Building (UPDA) for fifteen consecutive visits. They will be invited to attend the UPDA's dental clinics for their first visit for clinical screening and baseline sampling then for their consecutive sampling visits (14 visits) to attend Spinnaker Building, School of Sport, Health & Exercise Science, University of Portsmouth (SbUoP) for further sampling.
Visit 1 (30 minutes-1 hour): This visit will include clinical screening, consent and baseline samples taken and will take place at UPDA dental clinics. The mouths of participants will be screened for suitability to fit in either of the groups (healthy or dental erosion groups) depending on the presence or absence of dental erosion in their teeth. A BEWE will be used to screen as whether participants have erosion or not. It is a simple, reproducible and convenient scoring system that can be used for recording clinical findings of dental erosion. If BEWE score is greater than 8 per extant cumulative score and one score 3 in at least one sextant then this means the participant's mouth shows evidence of dental erosion. If a participant is found to be suitable based upon inclusion/exclusion criteria (see attached detailed protocol), they will be invited to attend further appointments.
A medical history, dental history and two further questionnaires (Diet Questionnaire and Reflux Disease Questionnaire) will be completed to ensure that they are suitable for this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria A) Healthy volunteers Group
- •Inclusion Criteria:
- •Be aged 18 to 75 years inclusive
- •Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
- •Give written informed consent
- •Be in good general health and oral health (without active caries lesions, gingivitis, periodontitis.
- •No diseases of the soft or hard tissues of the oral cavity
- •No other oral condition affecting the composition of the oral fluids and presented normal salivary flow (stimulated salivary flow >1 mL/min, unstimulated salivary flow > 0.25 mL/min; salivary pH > 6)
- •Show no evidence of dental erosion or/and active dental caries (with BEWE score ≤8 per extant cumulative score per patient and no clinically visible decayed teeth) B) Dental erosion group Inclusion Criteria
- •Same as above of healthy volunteers (1-6).
- •Show evidence of dental erosion (with BEWE score > 8 per extant cumulative score per patient and one score 3 in a sextant. BEWE is a simple, reproducible and convenient scoring system that can be used with the diagnostic criteria for recording clinical findings and examining dental hard tissues other than for caries, guiding the management of erosive tooth wear.
排除标准
- •Exclusion Criteria for both groups:
- •Smokers, using mouthwash or tongue scrapes
- •Presenting conditions associated with vomiting (e.g. anorexia or bulimia), bruxism and Gastro-oesophageal reflux disease (GORD)
- •Occupations associated with increased risk of erosion, such as swimmers and battery, charging and galvanizing workers.
- •Wearing orthodontic appliances
- •Use of antibiotics three (3) months prior to or during this study
- •Use of any over the counter medications other than analgesics
- •Pregnant or breastfeeding
- •Participation in another clinical study in the month preceding this study
- •Medical condition which requires pre-medication prior to dental visits/procedures.
- •Participants who have eaten/had anything to drink up to two hours before providing a sample (Two hours prior to the trial, participants will be instructed to eat a self-selected light meal and drink 500 ml of water. No other food or fluid will be allowed thereafter)
结局指标
主要结局
Identification of salivary proteins via SDS-PAGE Electrophoresis:
时间窗: Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28
SDS-PAGE will be used to identify salivary proteins in saliva and pellicle samples and any potential changes in protein bands at a variety of conditions.
Identification of salivary proteins via Proteomics analysis:
时间窗: Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28
will identify a number of salivary proteins in saliva and pellicle samples including prolactin inducible protein (PIP) and zinc-alpha-2 glycoprotein (ZAG)
Microbiome diversity using DNA extraction and 16s ribosomal RNA analysis
时间窗: Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28
Saliva and pellicle samples will be used to isolate bacterial DNA which will be quantified using a fluorometric method Results from the DNA sequencing will be directly compared between those individuals classified as showing dental erosion and those healthy participants.
次要结局
- Oxidative stress markers and redox-related molecules via ELISA:(Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28)
- Endothelial function test (Iontophoresis) of brachial artery:(Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28)
- Flow-mediated dilation (FMD) of brachial artery:(Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28)
- Nitrate and nitrite in saliva, plasma via Ozone-based chemiluminescence(Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28)
- Blood pressure measurement:(Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28)
研究者
Ant Shepherd
Dr Ant Shepherd - associate professor in clinical exercise physiology
University of Portsmouth