Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT06171594
Eligibility Criteria:
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:
\-
Exclusion Criteria for both groups:
1. Smokers, using mouthwash or tongue scrapes
2. Presenting conditions associated with vomiting (e.g. anorexia or bulimia), bruxism and Gastro-oesophageal reflux disease (GORD)
3. Occupations associated with increased risk of erosion, such as swimmers and battery, charging and galvanizing workers.
4. Wearing orthodontic appliances
5. Use of antibiotics three (3) months prior to or during this study
6. Use of any over the counter medications other than analgesics
7. 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 thereafter)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06171594
Study Brief:
Protocol Section:
NCT06171594