Clinical trial NCT05695105: Novel Treatment for Dental Ankylosis
Official title: Novel Treatment for Dental Ankylosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Ankylosis
Keywords: Dental ankylosis
Vibration
Electric toothbrush
Mini-implant
Heavy force
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change from the Baseline Ankylosed Tooth Position During 9 Months Period
timeFrame: 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.
measure: Change from the Baseline Alveolar Bone Defect Level of the Ankylosed Tooth During 9 Months Period
timeFrame: 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 outcomes:
measure: Mobility of Ankylosed Tooth
timeFrame: 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
measure: Ankylosed Tooth Periodontal Ligament (PDL) Obliteration
timeFrame: For vibration and mini-implant group only, on Day 0 and last day of clinical exam (either Day 98, 126, 154, or 198)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
Study officials:
affiliation: Rutgers School of Dental Medicine
name: Wei Huang, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.