The Effect of Nitrate Supplement on the Oral Microbiome, Salivary Pellicle Proteins and Vascular Function of Individuals With Dental Erosion
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Identification of salivary proteins via SDS-PAGE Electrophoresis:
研究概览
简要总结
Dental erosion happens when teeth lose some of their parts because of acid from the things people eat and/or drink or even from their stomach. It can make their 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 drinking beetroot juice affects these good bacteria in your mouth for people with healthy teeth and those with erosion. This study aims to find out if drinking beetroot juice 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 nitrate supplement on healthy control and people with dental erosion (PwDE). This study aims to explore the effect of nitrate supplement on oral microbiome in WMS and SP and its impact on blood pressure and arterial stiffness in healthy controls and 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 3 visits.
The proposed study is part of a PhD educational project and will be a double blind, randomised design, crossover trial for the effect of nitrate supplements on healthy control and PwDE. This study aims to explore the effect of nitrate supplements on oral microbiome recovery in whole mouth saliva (WMS) and salivary pellicle (SP) and its impact on blood pressure and arterial stiffness in PwDE and healthy controls. The reason this is coming to the HRA is because we do not have an HTA license at the University of Portsmouth.
This study will assess various biomarkers, including salivary proteins and oral microbiome, vascular function, nitrate-reducing activity of oral bacteria, and oxidative stress markers, to understand the impact of chlorhexidine mouthwash on oral and vascular health in PwDE and healthy individuals. The effect of CHX on the structure and composition of the oral microbiome in healthy and PwDE will be analysed. Furthermore, this study will analyse micro and macrovascular endothelial function changes in both groups (healthy and PwDE groups), linking changes to oral microbial communities and cardiovascular function.
Two groups of participants are required for this study [healthy (n=10) and PwDE (n=10) 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, 12 individuals will be recruited for each group (healthy and PwDE groups) to account for a 16% 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 events. 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).
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
- None
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
- •Smokers, using mouthwash or tongue scrapes.
- •Consumption of beetroot juice in normal diet (This will be determined from responses on the diet form).
- •Diagnosed with alcoholism (or drinking more than four times a week, or consuming at least 40 g in males and 20 g in females per day)
- •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 certain types of dental work on specific teeth (e.g., orthodontic appliances, extensive dental bridges, or recent oral surgery
- •Use of antibiotics three (3) months prior to or during this study
- •Use of any over the counter medications other than analgesics or have a known medical condition or currently taking any medication
- •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
研究组 & 干预措施
Active nitrate
Arm Description: Nitrate Intervention Arm
Intervention: Beetroot Juice (BJ) with Nitrate Supplements
Dosage Form: Liquid Dosage: 70 ml Frequency: Twice daily Duration: Seven days Participants assigned to this arm will receive Beetroot Juice (BJ) containing nitrate supplements. The intervention involves the ingestion of 70 ml of BJ twice daily for a duration of seven days. The BJ are designed to be indistinguishable in taste and appearance, ensuring blinding during the study. This arm is a crucial component of the double-blind, randomized crossover trial investigating the effects of nitrate supplements on oral microbiome recovery, blood pressure, and arterial stiffness in both healthy individuals and those with Dental Erosion. Detailed protocol and participant information available in attached documentation.
干预措施: Nitrate (Dietary Supplement)
Placebo nitrate
Arm Description: Placebo Intervention Arm
Intervention: Placebo ( Beetroot Juice depleted from nitrate), Identical to the active nitrate in texture, taste, colour and smell.
Dosage Form: Liquid Dosage: 70 ml Frequency: Twice daily Duration: Seven days Participants in the placebo intervention arm will receive a liquid placebo consisting of flavored water with discolouring dyes. The placebo is administered in the same manner as the active intervention, with participants ingesting 70 ml twice daily for a duration of seven days. This arm serves as a control group in the double-blind, randomized crossover trial, allowing for a comparison with the effects observed in the Beetroot Juice (BJ) with nitrate supplements arm. The order of treatment (BJ or placebo) is randomly assigned and reversed during the second phase of the study to ensure unbiased results. Detailed protocol and participant information available in attached documentation.
干预措施: Nitrate (Dietary Supplement)
结局指标
主要结局
Identification of salivary proteins via SDS-PAGE Electrophoresis:
时间窗: December 2024
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. Beetroot juice and placebo) on day 1
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. Beetroot juice and placebo) on day 1
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
- Blood pressure measurement:(Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1)
- Nitrate and nitrite in saliva, plasma via Ozone-based chemiluminescence(Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1)
- Endothelial function test (Iontophoresis) of brachial artery:(Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1)
- Flow-mediated dilation (FMD) of brachial artery:(Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1)
- Nitrate-reducing activity of oral bacteria(Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1)
- Oxidative stress markers and redox-related molecules via ELISA:(Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1)
研究者
Ant Shepherd
Dr Ant Shepherd
University of Portsmouth