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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT06641960
Eligibility Criteria:
Inclusion Criteria:
1. Adult healthy male and female patients aged 18-25 years.
2. Patients eligible for full arch upper and lower fixed labial orthodontic appliance treatment and molar band.
3. Patients with malocclusion class I, II, or III without crowding on the anterior teeth.
4. Permanent occlusion and existence of all the upper and lower teeth (except third molars).
5. Good oral and periodontal health:
* Probing depth \< 4 mm
* No radiographic evidence of bone loss.
* Gingival index ≤ 1
* Plaque index ≤ 1
Exclusion Criteria:
1. Previous orthodontic treatment history.
2. Patients with any systemic disorder that could influence periodontal conditions or response to treatment (such as hypertension, diabetes, or immunological disorders).
3. Patients were on systemic drugs, i.e., antibiotics, hypertensives, analgesics, hormonal drugs, sedatives, and anti-seizure medication, within three months before the baseline examination.
4. Patients who were allergic to ingredients of the probiotics lozenges.
5. Those undergoing periodontal treatment within three months before the baseline examination.
6. Smokers, pregnant or lactating women.
7. Regular use of antibacterial mouthwash.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT06641960
Study Brief:
Protocol Section:
NCT06641960