The Effect of Nitrate Supplement on the Oral Microbiome and Saliva in Dental Erosion

NCT06156618 | Unknown

• 1 other identifier: 334090
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Erosion

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Blood pressure measurement:

  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

• 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

Study Arms (2)

Active nitrate

ACTIVE COMPARATOR

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.

Dietary Supplement: Nitrate

Placebo nitrate

PLACEBO COMPARATOR

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.

Dietary Supplement: Nitrate

Interventions

Nitrate DIETARY_SUPPLEMENT

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.

Active nitrate; Placebo nitrate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility Criteria A) Healthy volunteers Group
• 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)
• \. 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.

You may not qualify if:

• 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 9. 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

Sponsors & Collaborators

• University of Portsmouth: lead

Study Sites (1)

University of Portsmouth Academy

Portsmouth, PO1 2QG, United Kingdom

Location

MeSH Terms

Conditions

Tooth Erosion

Interventions

Nitrates

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ant Shepherd

Model Details: this study will be a double blind, randomised design, crossover trial

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 5, 2023
• Study Start: November 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: December 20, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)