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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03179735
Eligibility Criteria:
Inclusion Criteria:
* good general health;
* class I or class II malocclusions with a nonsurgical orthodontic treatment plan for alignment and leveling including no-extraction, extraction of two upper premolars or extraction of four premolars; no previous orthodontic treatment; overbite and overjet that allowed brackets to be placed on the lower teeth without occlusal interferences;
* periodontal health (with no clinical signals of inflammation, GI \<1 e no clinical attachment loss);
* at least 26 natural teeth;
Exclusion Criteria:
* severe skeletal malocclusion in anteroposterior, vertical or transverse dimensions; surgical orthodontic plan;
* mouth breathing;
* gingivitis; periodontitis; gingival overgrowth;
* prosthetic fixed devices, removable partial dentures or overhanging restorations;
* systemic diseases or conditions that could influence the periodontal status;
* smokers and former-smokers;
* pregnancy or breast-feeding;
* history of sensitivity or suspected allergies following the use of oral hygiene products; any antibiotic prophylaxis;
* antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study;
* regular use of chemotherapeutic antiplaque/antigingivitis products;
* periodontal treatment performed within six months prior to study initiation;
* unwillingness to return for follow-up.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT03179735
Study Brief:
Protocol Section:
NCT03179735