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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT05695105
Eligibility Criteria:
Inclusion Criteria:
* Full informed consent and/or informed assent (minors)
* Be willing and able to comply with all study requirements
* Male or female
* Aged 6-30
* Clinically diagnosed to have either an ankylosed deciduous tooth or a non-third molar mildly- to moderately- ankylosed permanent tooth, and with crown partially visible in the oral cavity. Clinical diagnosis of ankylosis includes the following factors: dental trauma history, infra-eruption with no apparent mechanical obstruction or other cause, contralateral tooth in occlusal contact for over one year, decreased alveolar bone height, no or reduced tooth mobility, and x-ray or cone-beam computer tomography (CBCT) imaging indications of an obliterated PDL space. Ultimately, the diagnosis will be confirmed by lack of tooth movement discovered during orthodontic treatment or when subjected to a heavy force through our study (Phelan M K, et al. 1990).
* English speaking (primary language or fluent)
Exclusion Criteria:
* Severe and extensive ankylosis of permanent teeth as diagnosed through CBCT
* Primary failure of eruption with previous orthodontic treatment
* Any systemic disorders particularly those affecting bleeding or skeletal health
* Any systemic medications
* Any mental or developmental disorders that affect patient understanding or compliance
* Allergic to our local anesthetic drug
* Can pass an infectious disease to someone else right now (e.g., having a flu)
* Is pregnant
* Has a history of smoking
* Have not reached the age of 6 or older than age of 30
* Not cooperative enough during dental examinations
* The dentist finds out that he/she is not able to keep the mini-implant, the brackets and the wires in place around the tooth that is being treated
* Not fluent in English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
30 Years
Study:
NCT05695105
Study Brief:
Protocol Section:
NCT05695105