The Effect of Chlorhexidine on the Oral Microbiome and Saliva in Dental Erosion (NCT06171594) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Chlorhexidine on the Oral Microbiome and Saliva in Dental Erosion
United Kingdom24 participantsStarted 2023-12-20
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion criteria
✕. Smokers, using mouthwash or tongue scrapes
✕. Presenting conditions associated with vomiting (e.g. anorexia or bulimia), bruxism and Gastro-oesophageal reflux disease (GORD)
What they're measuring
1
Identification of salivary proteins via SDS-PAGE Electrophoresis:
Timeframe: Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28
2
Identification of salivary proteins via Proteomics analysis:
Timeframe: Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28
3
Microbiome diversity using DNA extraction and 16s ribosomal RNA analysis
Timeframe: Baseline (day -7), post each intervention (i.e. mouthwash and placebo) on days 0,1,3,7,14,21,28