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Novel Treatment for Dental Ankylosis

Primary Purpose

Dental Ankylosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electric Toothbrush-Generated Vibration
Mini-Implant-Assisted Orthodontic Treatment
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Ankylosis focused on measuring Dental ankylosis, Vibration, Electric toothbrush, Mini-implant, Heavy force

Eligibility Criteria

6 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vibration Group

Vibration and Mini-implant Group

Arm Description

For primary and permanent teeth that will receive only toothbrush vibration treatment.

For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
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).

Full Information

First Posted
October 4, 2022
Last Updated
May 25, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05695105
Brief Title
Novel Treatment for Dental Ankylosis
Official Title
Novel Treatment for Dental Ankylosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Ankylosis
Keywords
Dental ankylosis, Vibration, Electric toothbrush, Mini-implant, Heavy force

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibration Group
Arm Type
Experimental
Arm Description
For primary and permanent teeth that will receive only toothbrush vibration treatment.
Arm Title
Vibration and Mini-implant Group
Arm Type
Experimental
Arm Description
For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment.
Intervention Type
Device
Intervention Name(s)
Electric Toothbrush-Generated Vibration
Intervention Description
Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth
Intervention Type
Device
Intervention Name(s)
Mini-Implant-Assisted Orthodontic Treatment
Intervention Description
Testing mini-implant-assisted heavy force application to treat ankylosis of teeth
Primary Outcome Measure Information:
Title
Change from the Baseline Ankylosed Tooth Position During 9 Months Period
Description
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.
Time Frame
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.
Title
Change from the Baseline Alveolar Bone Defect Level of the Ankylosed Tooth During 9 Months Period
Description
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.
Time Frame
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 Measure Information:
Title
Mobility of Ankylosed Tooth
Description
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)
Time Frame
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
Title
Ankylosed Tooth Periodontal Ligament (PDL) Obliteration
Description
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).
Time Frame
For vibration and mini-implant group only, on Day 0 and last day of clinical exam (either Day 98, 126, 154, or 198)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Huang, DDS, PhD
Phone
973-972-4729
Email
wei.huang.ortho@sdm.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Chapman-Greene, PhD
Phone
973-972-3620
Email
chapmaje@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Huang, DDS, PhD
Organizational Affiliation
Rutgers School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers School of Dental Medicine
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Huang, DDS, PhD
Phone
973-972-4729
Email
wei.huang.ortho@sdm.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Julie Chapman-Greene, PhD
Phone
973-972-3620
Email
chapmaje@rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26677103
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.
Results Reference
background
PubMed Identifier
23729457
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.
Results Reference
background
PubMed Identifier
11411080
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.
Results Reference
background
PubMed Identifier
6575989
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.
Results Reference
background
PubMed Identifier
6438004
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.
Results Reference
background
PubMed Identifier
32644898
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.
Results Reference
background
PubMed Identifier
26062278
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.
Results Reference
background
PubMed Identifier
28247574
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.
Results Reference
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Novel Treatment for Dental Ankylosis

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