Novel Treatment for Dental Ankylosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Treatment for Dental Ankylosis

Conditions
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Dental Ankylosis

Intervention / Treatment
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* Device: Electric Toothbrush-Generated Vibration
* Device: Mini-Implant-Assisted Orthodontic Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration Group<br>For primary and permanent teeth that will receive only toothbrush vibration treatment. | Device: Electric Toothbrush-Generated Vibration<br>* Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth<br>|
| Experimental: Vibration and Mini-implant Group<br>For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment. | Device: Electric Toothbrush-Generated Vibration<br>* Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth<br>Device: Mini-Implant-Assisted Orthodontic Treatment<br>* Testing mini-implant-assisted heavy force application to treat ankylosis of teeth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the Baseline Ankylosed Tooth Position During 9 Months Period | The change of ankylosed tooth position will be assessed clinically and radiographically through measuring the distance (mm) of the lowest (maxillary arch) or highest (mandibular arch) cusp tip to the occlusal plane where full occlusal contact would have been established. | For vibration group, it will be on Day 0, 33, 61, 89 if necessary after vibration; for vibration and mini-implant group, it will be on Day 0, 33, 61, 89, 131, 159, 187, 215, 243, 271 if necessary after mini-implant placement. | 
| Change from the Baseline Alveolar Bone Defect Level of the Ankylosed Tooth During 9 Months Period | The vertical alveolar bone defect at the ankylosed tooth position will be assessed clinically through measuring the periodontal probing depth (mm) and radiographically through measuring the distance between the alveolar bone attachment position to the neighboring tooth's cementum-enamel junction (CEJ) in the tooth's long axis direction (mm). The change of these measurements will be recorded. | For vibration group, it will be on Day 0 and the last day of visit (Day 33, 61 or 89, depending on the outcome); for vibration and mini-implant group, it will be on Day 0 and the last day of visit from the vibration phase and Day 131, 215 if necessary. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility of Ankylosed Tooth | The mobility of the ankylosed tooth will be assessed clinically. Mobility will be classified into three Grades: Grade 1: < 1 mm (horizontal) Grade 2: > 1 mm (horizontal) Grade 3: > 1 mm (horizontal+vertical mobility) | For vibration group, on Day 0, 6, 33, 61, 89 if necessary; for vibration and mini-implant group on Day 0, 42, 70, 98, 126, 154, 198 if necessary | 
| Ankylosed Tooth Periodontal Ligament (PDL) Obliteration | The PDL obliteration will be assessed radiographically using small field of view Cone Bean Computed Tomography (CBCT) images. Examiner will assess the CBCT images and determine the PDL obliteration area and changes (increased, decreased, disappeared). | For vibration and mini-implant group only, on Day 0 and last day of clinical exam (either Day 98, 126, 154, or 198) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental ankylosis, Vibration, Electric toothbrush, Mini-implant, Heavy force