Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2023-07-10
2025-12-16
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Vibration Group
For primary and permanent teeth that will receive only toothbrush vibration treatment.
Electric Toothbrush-Generated Vibration
Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth
Vibration and Mini-implant Group
For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment.
Electric Toothbrush-Generated Vibration
Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth
Mini-Implant-Assisted Orthodontic Treatment
Testing mini-implant-assisted heavy force application to treat ankylosis of teeth
Interventions
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Electric Toothbrush-Generated Vibration
Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth
Mini-Implant-Assisted Orthodontic Treatment
Testing mini-implant-assisted heavy force application to treat ankylosis of teeth
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
30 Years
ALL
No
Sponsors
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Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Wei Huang, DMD, PhD, MSD
Assistant Professor
Principal Investigators
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Wei Huang, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers School of Dental Medicine
Locations
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Rutgers School of Dental Medicine
Newark, New Jersey, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Pro2020003227
Identifier Type: -
Identifier Source: org_study_id
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