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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07349056
Eligibility Criteria:
Inclusion Criteria:
* Adults aged ≥18 years.
* Presence of a Class III molar relationship of any severity at baseline.
* Presence of a Class II molar relationship of any severity at baseline.
* Presence of transverse arch discrepancies.
* Presence of vertical maxillary excess.
* Presence of maxillary and/or mandibular asymmetry.
* Presence of anterior open bite.
* Full permanent dentition up to the first molars, with no supernumerary teeth and no agenesis (congenital absence) of teeth up to the first molars.
* No previous orthodontic treatment.
* No history of tooth extraction other than second or third molars.
* Availability of complete baseline and end-of-follow-up periodontal parameters and phenotype records suitable for evaluation.
* Healthy periodontium with no signs of gingival hypertrophy.
* No systemic disease history or medication use that could affect gingival/periodontal conditions.
Exclusion Criteria:
* Patients planned for orthodontic camouflage treatment with fixed appliances for Class II/Class III correction instead of orthognathic surgery.
* History of interproximal enamel reduction (interproximal stripping).
* Presence of dental implants.
* Age \< 18 years.
* Pregnant or breastfeeding individuals.
* Any systemic condition contraindicates orthognathic surgery.
* Psychiatric disorders.
* Syndromic conditions.
* History of previous orthognathic surgery.
* Refusal to sign the informed consent form.
* Individuals belonging to a vulnerable population.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07349056
Study Brief:
Protocol Section:
NCT07349056