CompletedNot Applicable

Novel Treatment for Dental Ankylosis

United States5 participantsStarted 2023-07-10

Plain-language 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.

Who can participate

Age range6 Years – 30 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * H…

What they're measuring

Change from the Baseline Ankylosed Tooth Position During 9 Months Period

Timeframe: For vibration group, it will be on Day 0, 33, 61, 89 if necessary after vibration; for vibration and mini-implant group, it will be on Day 0, 33, 61, 89, 131, 159, 187, 215, 243, 271 if necessary after mini-implant placement.

Change from the Baseline Alveolar Bone Defect Level of the Ankylosed Tooth During 9 Months Period

Timeframe: For vibration group, it will be on Day 0 and the last day of visit (Day 33, 61 or 89, depending on the outcome); for vibration and mini-implant group, it will be on Day 0 and the last day of visit from the vibration phase and Day 131, 215 if necessary.

Trial details

NCT IDNCT05695105

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-16

View on ClinicalTrials.gov More Dental Ankylosis trials