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

NCT06171594 | Unknown

• 1 other identifier: 333173
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

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.

  Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28

• 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. mouthwash and placebo) on days 0,1,3,7,14,21,28

• 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. mouthwash and placebo) on days 0,1,3,7,14,21,28

Secondary Outcomes (5)

• Blood pressure measurement:

  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

• 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

Study Arms (2)

Active chlorhexidine

ACTIVE COMPARATOR

Arm Description 2: Antibacterial CHX Mouthwash Arm This arm involves participants who have been randomly assigned to receive an antibacterial CHX mouthwash containing 0.2% CHX (Corsodyl Mint, GlaxoSmithKline, UK). Similar to Arm 1, the intervention period spans seven days, during which participants will rinse their mouth with 10 mL of antibacterial CHX mouthwash twice daily. The active CHX mouthwash and the placebo mouthwash are indistinguishable in taste, appearance, color, texture, and smell. Participants in this arm will follow the rinse regimen for 7 days, taking the final tube the morning before their next visit (Visit 2 - 8). After the completion of Visit 8, each participant will undergo a washout period of 12 weeks before starting the 7-day reverse order of the given product administration as part of the crossover design.

Combination Product: Chlorhexidine mouthwash

Placebo Chlorhexidine

PLACEBO COMPARATOR

Arm Description 1: Placebo CHX Mouthwash Arm This arm involves participants who have been randomly assigned to receive a placebo CHX mouthwash. The intervention period spans seven days, during which participants in this arm will rinse their mouth with 10 mL of CHX placebo mouthwash (ultrapure mint-flavoured water) twice daily. The placebo mouthwash is designed to be identical in taste, appearance, colour, texture, and smell to the active mouthwash, ensuring blinding during the study. Participants in this arm will follow the rinse regimen for 7 days, taking the final tube the morning before their next visit (Visit 2 - 8). After the completion of Visit 8, each participant will undergo a washout period of 12 weeks before starting the 7-day reverse order of the given product administration as part of the crossover design.

Combination Product: Chlorhexidine mouthwash

Interventions

Chlorhexidine mouthwash COMBINATION_PRODUCT

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

Active chlorhexidine; Placebo Chlorhexidine

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
• 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)

Sponsors & Collaborators

• University of Portsmouth: lead

Study Sites (1)

University of Portsmouth Academy

Portsmouth, PO1 2QG, United Kingdom

Location

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Central Study Contacts

Anthony Shepherd, PhD

CONTACT

02392845289; ant.shepherd@port.ac.uk

Mahdi Mutahar, PhD

CONTACT

02392845528; mahdi.mutahar@port.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ant Shepherd - associate professor in clinical exercise physiology

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 14, 2023
• Study Start: December 20, 2023
• Primary Completion: July 30, 2024
• Study Completion: December 20, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)