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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibration Group | Experimental | For primary and permanent teeth that will receive only toothbrush vibration treatment. |
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| Vibration and Mini-implant Group | Experimental | For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric Toothbrush-Generated Vibration | Device | Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Huang, DDS, PhD | Rutgers School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers School of Dental Medicine | Newark | New Jersey | 07103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26677103 | Background | de Souza RF, Travess H, Newton T, Marchesan MA. Interventions for treating traumatised ankylosed permanent front teeth. Cochrane Database Syst Rev. 2015 Dec 16;2015(12):CD007820. doi: 10.1002/14651858.CD007820.pub3. | |
| 23729457 | Background | Tieu LD, Walker SL, Major MP, Flores-Mir C. Management of ankylosed primary molars with premolar successors: a systematic review. J Am Dent Assoc. 2013 Jun;144(6):602-11. doi: 10.14219/jada.archive.2013.0171. |
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| ID | Term |
|---|---|
| D020254 | Tooth Ankylosis |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Mini-Implant-Assisted Orthodontic Treatment | Device | Testing mini-implant-assisted heavy force application to treat ankylosis of teeth |
|
| 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) |
| 11411080 | Background | Andersson L, Malmgren B. The problem of dentoalveolar ankylosis and subsequent replacement resorption in the growing patient. Aust Endod J. 1999 Aug;25(2):57-61. doi: 10.1111/j.1747-4477.1999.tb00088.x. |
| 6575989 | Background | Mueller CT, Gellin ME, Kaplan AL, Bohannan HM. Prevalence of ankylosis of primary molars in different regions of the United States. ASDC J Dent Child. 1983 May-Jun;50(3):213-8. No abstract available. |
| 6438004 | Background | Andersson L, Blomlof L, Lindskog S, Feiglin B, Hammarstrom L. Tooth ankylosis. Clinical, radiographic and histological assessments. Int J Oral Surg. 1984 Oct;13(5):423-31. doi: 10.1016/s0300-9785(84)80069-1. |
| 32644898 | Background | Oh NY, Nam SH, Lee JS, Kim HJ. Delayed Spontaneous Eruption of Severely Infraoccluded Primary Second Molar: Two Case Reports. J Clin Pediatr Dent. 2020;44(3):185-189. doi: 10.17796/1053-4625-44.3.9. |
| 26062278 | Background | Djemal S, Karki T, Mack G. Challenges in treating traumatically intruded and ankylosed permanent incisors: a case report with a multidisciplinary approach. Dent Update. 2015 Jan-Feb;42(1):44-6, 49-50. doi: 10.12968/denu.2015.42.1.44. |
| 28247574 | Background | Mistry VN, Barker CS, James Spencer R. The first permanent molar: spontaneous eruption after a five-year failure. Int J Paediatr Dent. 2017 Sep;27(5):428-433. doi: 10.1111/ipd.12293. Epub 2017 Mar 1. |