Dental Erosion Clinical Trial
Official title:
The Effect of Nitrate Supplement on the Oral Microbiome, Salivary Pellicle Proteins and Vascular Function of Individuals With Dental Erosion
Verified date | November 2023 |
Source | University of Portsmouth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | December 20, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: Eligibility Criteria A) Healthy volunteers Group Inclusion Criteria: 1. Be aged 18 to 75 years inclusive 2. Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present 3. Give written informed consent 4. Be in good general health and oral health (without active caries lesions, gingivitis, periodontitis. 5. No diseases of the soft or hard tissues of the oral cavity 6. 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) 7. 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 1. Same as above of healthy volunteers (1-6). 2. 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. - Exclusion Criteria: 1. Smokers, using mouthwash or tongue scrapes. 2. Consumption of beetroot juice in normal diet (This will be determined from responses on the diet form). 3. 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) 4. Presenting conditions associated with vomiting (e.g. anorexia or bulimia), bruxism and Gastro-oesophageal reflux disease (GORD) 5. Occupations associated with increased risk of erosion, such as swimmers and battery, charging and galvanizing workers. 6. Wearing certain types of dental work on specific teeth (e.g., orthodontic appliances, extensive dental bridges, or recent oral surgery 7. Use of antibiotics three (3) months prior to or during this study 8. Use of any over the counter medications other than analgesics or have a known medical condition or currently taking any medication 9. Pregnant or breastfeeding 8. Participation in another clinical study in the month preceding this study 9. Medical condition which requires pre-medication prior to dental visits/procedures. 10. 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Portsmouth Academy | Portsmouth |
Lead Sponsor | Collaborator |
---|---|
University of Portsmouth |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of salivary proteins via SDS-PAGE Electrophoresis: | 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. | December 2024 | |
Primary | Identification of salivary proteins via Proteomics analysis: | will identify a number of salivary proteins in saliva and pellicle samples including prolactin inducible protein (PIP) and zinc-alpha-2 glycoprotein (ZAG) | Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1 | |
Primary | Microbiome diversity using DNA extraction and 16s ribosomal RNA analysis | 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. | Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1 | |
Secondary | Blood pressure measurement: | Blood pressure of the brachial artery will be measured following 30 minutes of seated rest in a quiet room using an automated sphygmomanometer. A total of five successive measurements will be taken, with 1-minute rest between readings, with the mean of the final three measurements will be recorded. The mean of the systolic (SBP), diastolic (DBP) and mean arterial pressure (MAP) measurements will be recorded. | Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1 | |
Secondary | Endothelial function test (Iontophoresis) of brachial artery: | Iontophoresis will permit the transdermal delivery of Acetylcholine (Ach) and sodium nitroprusside (SNP) to the volar aspect of the right forearm. These chemicals will be introduced through a process called Iontophoresis. Iontophoresis is a unique test where we use a gentle electrical charge to help specific substances get into your skin. This method is beneficial for carefully delivering therapeutic agents through skin or for diagnostic reasons. | Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1 | |
Secondary | Flow-mediated dilation (FMD) of brachial artery: | Brachial artery endothelium-dependent function will be measured using the FMD technique as previously described. FMD represents an endothelium-dependent, largely NO-mediated dilatation of conduit arteries in response to an imposed increase in blood flow and shear stress. A high-resolution ultrasound machine will be used to image the brachial artery in the distal third of the upper arm. | Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1 | |
Secondary | Nitrate-reducing activity of oral bacteria | To assess the nitrate-reducing activity of oral bacteria for evaluation of nitrate-reducing activity in oral bacteria through a meticulously outlined sequence of future steps. | Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1 | |
Secondary | Nitrate and nitrite in saliva, plasma via Ozone-based chemiluminescence | Blood samples:
Venous blood will be collected and analysed for NO3- and NO2- content Saliva samples: The WMS will be collected and analysed for NO3- and NO2- content |
Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1 | |
Secondary | Oxidative stress markers and redox-related molecules via ELISA: | ELISA will be used to identify some common Oxidative stress markers and redox-related molecules such as 3-NO-Tyr in saliva and blood samples | Baseline (day -7), post each intervention (i.e. Beetroot juice and placebo) on day 1 |
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