Novel Treatment for Dental Ankylosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 30 Years
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05695105
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rutgers, The State University of New Jersey
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Wei Huang, DDS, PhD
Principal Investigator Affiliation Rutgers School of Dental Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dental Ankylosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Vibration Group

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

Experimental: Vibration and Mini-implant Group

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

Interventions

Device: - Electric Toothbrush-Generated Vibration

Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth

Device: - Mini-Implant-Assisted Orthodontic Treatment

Testing mini-implant-assisted heavy force application to treat ankylosis of teeth

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rutgers School of Dental Medicine, Newark, New Jersey

Status

Recruiting

Address

Rutgers School of Dental Medicine

Newark, New Jersey, 07103

Site Contact

Wei Huang, DDS, PhD

[email protected]

973-972-4729