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NCT05695105 | Recruiting | Dental Ankylosis

Novel Treatment for Dental Ankylosis
Sponsor:

Rutgers, The State University of New Jersey

Information provided by (Responsible Party):

Wei Huang, DDS, PhD, MSD

Brief 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.

Condition or disease

Dental Ankylosis

Intervention/treatment

Electric Toothbrush-Generated Vibration

Mini-Implant-Assisted Orthodontic Treatment

Phase

Not Applicable

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 20 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Novel Treatment for Dental Ankylosis
Actual Study Start Date : July 10, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025
Arm Intervention/treatment

Experimental: Vibration Group

For primary and permanent teeth that will receive only toothbrush vibration treatment.

Device: Electric Toothbrush-Generated Vibration

Experimental: Vibration and Mini-implant Group

For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment.

Device: Electric Toothbrush-Generated Vibration
Ages Eligible for Study: 6 Years to 30 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Novel Treatment for Dental Ankylosis

Location Details

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Novel Treatment for Dental Ankylosis

How to Participate

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Locations

Recruiting

United States, New Jersey

Rutgers School of Dental Medicine

Newark, New Jersey, United States, 07103