Novel Treatment for Dental Ankylosis

Last updated: September 6, 2024
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Electric Toothbrush-Generated Vibration

Mini-Implant-Assisted Orthodontic Treatment

Clinical Study ID

NCT05695105
Pro2020003227
  • Ages 6-30
  • All Genders

Study 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

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-thirdmolar mildly- to moderately- ankylosed permanent tooth, and with crown partiallyvisible in the oral cavity. Clinical diagnosis of ankylosis includes the followingfactors: dental trauma history, infra-eruption with no apparent mechanicalobstruction or other cause, contralateral tooth in occlusal contact for over oneyear, decreased alveolar bone height, no or reduced tooth mobility, and x-ray orcone-beam computer tomography (CBCT) imaging indications of an obliterated PDLspace. Ultimately, the diagnosis will be confirmed by lack of tooth movementdiscovered during orthodontic treatment or when subjected to a heavy force throughour study (Phelan M K, et al. 1990).

  • English speaking (primary language or fluent)

Exclusion

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 orcompliance

  • 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 bracketsand the wires in place around the tooth that is being treated

  • Not fluent in English

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Electric Toothbrush-Generated Vibration
Phase:
Study Start date:
July 10, 2023
Estimated Completion Date:
December 31, 2025

Study Description

Currently, there is no treatment available to reverse ankylosis' pathology and therefore it often leads to extraction of the tooth in young patients to prevent more serious pathological complications. In this study, the investigators will use toothbrush-generated vibration and mini-implant-assisted heavy force delivery approaches to treating ankylosis in deciduous and permanent teeth. If successful, the techniques will completely restore the full eruption capacity of an ankylosed tooth by reversing its pathological development. The purpose of the research is to investigate whether a new treatment approach provides an effective noninvasive or minimally invasive treatment for dental ankylosis.

Study participants will be asked to use an electric toothbrush handle to vibrate the ankylosed tooth for 15-60 seconds every day for five days and have a few follow-up visits to the clinic. If the ankylosed tooth is a permanent tooth and the electric toothbrush vibration approach does not work, the participants will be asked to have a six-week period of orthodontic treatment for the tooth with the placement of a mini-implant near the tooth and then have monthly follow-up visits for up to five months.

Connect with a study center

  • Rutgers School of Dental Medicine

    Newark, New Jersey 07103
    United States

    Active - Recruiting

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