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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01622920
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adults over 18 years (females and males) with normal salivary flow.
2. Volunteers with absence of dental caries and/or periodontal disease on the maxillary incisors (upper front teeth) to be used in the study.
3. Volunteers should have sound maxillary incisors with no obvious cracks in the crown.
4. Volunteers who willingly signed an informed consent.
5. Volunteers who are willing to follow the research schedule for the period of the study.
Exclusion Criteria:
1. Volunteers with abnormal enamel on maxillary incisors assessed by visual inspection.
2. Volunteers with replaced enamel on maxillary incisors (eg fillings, crowns, bridges).
3. Volunteers who appear to have hypoplastic teeth as part of a syndrome, e.g. osteogenesis imperfect.
4. Volunteers having orthodontic appliances on front teeth, or presence of fixed or removable dentures (replacing missing front teeth).
5. Volunteers who have a complex dental history such as periodontitis, dentine sensitivity or salivary dysfunction.
6. Volunteers who have any condition could be expected to interfere with the volunteer's safety during the study.
7. Volunteers who demonstrate an inability to comply with study procedures.
8. Signed informed consent not obtained by the volunteer.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01622920
Study Brief:
Protocol Section:
NCT01622920