NCT05695105

Novel Treatment for Dental Ankylosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 6 Years – 30 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Dental Ankylosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-10
• Primary completion: 2025-12-16
• Completion: 2025-12-16
• First posted: 2023-01-23
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study