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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT02549950
Eligibility Criteria:
Study Subjects for Part I and Part II:
Inclusion:
* Voluntary participation of patients only
* Able to follow instruction, able to understand the consent form and sign it.
* Adult Female and Male Saudi patients 15-35 y.o
* Subjects who are none smokers
* Subjects with good health according to American Society of Anesthesiology ASA-I with full permanent dentition regardless of the third molars.
* Subjects with good periodontal and gingival health: Gingival Index GI≤ 1
* Subjects with a none gummy smile,
* Subjects with full complement of permanent caries-free dentition; Restored teeth should be of proper sound intact fillings
* Subjects without root anomalies
* Subjects with mild-moderate skeletal and dental cephalometric measurements: OB ≤ 40%, OJ ≤ 6, ANB ≤ 5 °, SN-GOGN ≤ 29 °, Subjects' dentition Angle classification class II div 1, 3mm molar and canine occlussal relationship; and subjects with class 1 Bi-maxillary protrusion
Exclusion:
* Subjects younger than 15 y.o
* Subjects who cannot comprehend the surgical procedure and who cannot consent for themselves
* Subjects who are medically classified as ASA-II, III
* Subjects who are taking any systemic or local medications especially Insulin, non-steroidal anti-inflammatory drugs, bisphosphonate, corticosteroids
* Subjects who are pregnant
* Subjects who are smokers
* Subjects with craniofacial syndromes: cleft lip and palate; or facial trauma
* Subjects with unhealthy or compromised periodontium
* Subjects with a gummy smile
* Subjects with inadequately treated endodontic and dental fillings problems
* Subjects with previous root resorption or dental developmental anomalies
* Subjects who had previous orthodontic treatment
* Subjects with TMJ signs and symptoms; Mandibular functional shift
* Subjects with extreme skeletal and dental class II: SN-GOGN ≥ 32°, OJ ≥ 6mm
* Subjects will be excluded if broken brackets or lost coils which have not been replaced immediately within few days from breakage or loss.
* Subjects will be excluded if any of mini-screws failed during treatment
* Subjects who become medically unfit during course of trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
35 Years
Study:
NCT02549950
Study Brief:
Protocol Section:
NCT02549950