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:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT05647369
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for the trial must comply with all of the following at randomization:
• Age between 13 and 18 years for the group with conventional orthodontic appliances.
This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece). Younger patients might present with cooperation problems.
* Good general health.
* Orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction.
* Total initial VSCs levels above the baseline level of 150ppb.
Exclusion Criteria:
Patients will be excluded for any of the following reasons:
* Active caries
* Periodontitis
* Dental fluorosis / dysplasia of the teeth
* Syndromes, mental disabilities and craniofacial deformities
* Smoking or use of other tobacco products
* Allergy to mastic
* Antibiotics during the last 2 months
* Chlorhexidine in the previous 3 weeks
* Participation in other trials
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT05647369
Study Brief:
Protocol Section:
NCT05647369