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 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT06668194
Eligibility Criteria:
Inclusion Criteria:
* Healthy patient, non-smoker
* Age: 11 - 16 years of age, inclusive.
* A full complement of dentition (central incisor to 1st molar) in the four quadrants, except second molars
* Patients requiring at least upper bilaterally maxillary 1st premolar extraction as a treatment plan (Class I bimaxillary protrusion/ crowding or Class II maxillary dentoalveolar protrusion/ crowding)
* At least 5 mm of space left between canine and 2nd premolar to be closed at the time of canine retraction
* At least six months after the extraction of first premolars and in a 0.019 x 0.025-inch stainless steel archwire in the maxilla
* The ability to read and understand English and to provide informed consent
Exclusion Criteria:
* Patients under 11 years of age and over the age of 16.
* Non-extraction treatment plan
* Extraction of maxillary tooth other than first premolars bilaterally.
* Evidence of poor oral hygiene
* Evidence of previous root resorption
* Missing or impacted tooth in any of the quadrant except 3rd molars.
* Medical issues that affect tooth movement
* Inability to provide oral and written consent to participate.
* Patient on medications that may alter bone metabolisms like bisphosphonates, oral contraceptives, or PTH (parathyroid hormone)
* Chronic illness or syndromic patients.
* Pregnant women, prisoners, and decisional impaired
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
16 Years
Study:
NCT06668194
Study Brief:
Protocol Section:
NCT06668194