New methods to treat dental ankylosis
Novel Treatment for Dental Ankylosis
NA · Rutgers, The State University of New Jersey · NCT05695105
This study is testing new ways to help young people with dental ankylosis, using vibrations from an electric toothbrush and possibly braces, to see if it can help their teeth grow properly without needing to pull them out.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Years to 30 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Locations | 1 site (Newark, New Jersey) |
| Trial ID | NCT05695105 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate innovative treatment methods for dental ankylosis, a condition where teeth become fused to the bone, hindering their growth. Participants will use an electric toothbrush to generate vibrations on the affected tooth and, if necessary, undergo mini-implant-assisted orthodontic treatment. The goal is to restore the eruption capacity of ankylosed teeth in young patients, potentially avoiding tooth extraction. The study will involve daily vibrations for five days, followed by orthodontic treatment if initial methods are unsuccessful.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 6-30 with clinically diagnosed ankylosed deciduous or mildly to moderately ankylosed permanent teeth.
Not a fit: Patients with severe ankylosis or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a noninvasive solution to restore normal tooth eruption in patients with dental ankylosis.
How similar studies have performed: While there is limited research on these specific methods, the innovative approach of using vibration and mini-implants for dental ankylosis treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newark, New Jersey
- Rutgers School of Dental Medicine — Newark, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Wei Huang, DDS, PhD — Rutgers School of Dental Medicine
- Study coordinator: Wei Huang, DDS, PhD
- Email: wei.huang.ortho@sdm.rutgers.edu
- Phone: 973-972-4729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Ankylosis, Dental ankylosis, Vibration, Electric toothbrush, Mini-implant, Heavy force