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NCT05695105
Novel Treatment for Dental Ankylosis
Conditions: Dental Ankylosis
Sex: All
Ages: 6 Years – 30 Years
Phase: NA
Enrollment: 20
Sponsor: Rutgers, The State University of New Jersey
Location: United States
Summary
The study is to determine whether one (or two) new method(s) will help treat dental ankylosis.
This study tackles the challenging tooth-bone fusion disorder of ankylosis.
In growing patients, ankylosis causes significant developmental bone defects due to its inhibition of the vertical growth of the affected alveolar bone area.
Eligibility Criteria
Inclusion Criteria:Full informed consent and/or informed assent (minors)Be willing and able to comply with all study requirementsMale or femaleAged 6-30Clinically 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 CBCTPrimary failure of eruption with previous orthodontic treatmentAny systemic disorders particularly those affecting bleeding or skeletal healthAny systemic medicationsAny mental or developmental disorders that affect patient understanding or complianceAllergic to our local anesthetic drugCan pass an infectious disease to someone else right now (e.g., having a flu)Is pregnantHas a history of smokingHave not reached the age of 6 or older than age of 30Not cooperative enough during dental examinationsThe 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 treatedNot fluent in English
Source: ClinicalTrials.gov (NCT05695105). StuddyBuddy aggregates publicly available trial information.