Dental AnkylosisNCT05695105
Novel Treatment for Dental Ankylosis
A study testing Electric Toothbrush-Generated Vibration and Mini-Implant-Assisted Orthodontic Treatment in people with Dental Ankylosis, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Dental Ankylosis
- What is being tested?
- Electric Toothbrush-Generated Vibration and Mini-Implant-Assisted Orthodontic Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
About this study
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.
Read the 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.
- Conditions
- Dental Ankylosis
- Being tested
- Electric Toothbrush-Generated Vibration, Mini-Implant-Assisted Orthodontic Treatment
- Keywords
- Dental ankylosis, Vibration, Electric toothbrush, Mini-implant, Heavy force
- Medical subject headings
- Tooth Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric Toothbrush-Generated VibrationDevice
Testing electric toothbrush handle-generated vibration to treat ankylosis of teeth
Mini-Implant-Assisted Orthodontic TreatmentDevice
Testing mini-implant-assisted heavy force application to treat ankylosis of teeth
| Study group | Role | What they receive |
|---|---|---|
| Vibration Group | Experimental | For primary and permanent teeth that will receive only toothbrush vibration treatment. Receives: Device: Electric Toothbrush-Generated Vibration |
| Vibration and Mini-implant Group | Experimental | For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment. Receives: Device: Electric Toothbrush-Generated Vibration; Device: Mini-Implant-Assisted Orthodontic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 (2)
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)
Measured: 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).
Measured: For vibration and mini-implant group only, on Day 0 and last day of clinical exam (either Day 98, 126, 154, or 198)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start10 Jul 2023
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental AnkylosisStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Huang, DMD, PhD, MSD, Rutgers, The State University of New Jersey
- Investigators
- Wei Huang, DDS, PhD, Principal investigator, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695105
- Sponsor's protocol ID
- Pro2020003227
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26677103Tieu 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.
PubMed 23729457Andersson 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.
PubMed 11411080Mueller 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.
PubMed 6575989Andersson 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.
PubMed 6438004Oh 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.
PubMed 32644898Djemal 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.
PubMed 26062278Mistry 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.
PubMed 28247574
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment for Dental Ankylosis
- ClinicalTrials.gov ID
- NCT05695105
- Acronym / sponsor ID
- Pro2020003227
- Conditions
- Dental Ankylosis
- Keywords
- Dental ankylosis, Vibration, Electric toothbrush, Mini-implant, Heavy force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration Group | Experimental | Device: Electric Toothbrush-Generated VibrationFor primary and permanent teeth that will receive only toothbrush vibration treatment. |
| Vibration and Mini-implant Group | Experimental | Device: Electric Toothbrush-Generated Vibration, Device: Mini-Implant-Assisted Orthodontic TreatmentFor permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric Toothbrush-Generated VibrationTesting electric toothbrush handle-generated vibration to treat ankylosis of teeth | Device | Vibration Group, Vibration and Mini-implant Group |
| Mini-Implant-Assisted Orthodontic TreatmentTesting mini-implant-assisted heavy force application to treat ankylosis of teeth | Device | Vibration and Mini-implant Group |
Primary outcome
Change from the Baseline Ankylosed Tooth Position During 9 Months Period
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.
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
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.
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.
2 secondary outcomes
Mobility of Ankylosed Tooth
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
Ankylosed Tooth Periodontal Ligament (PDL) Obliteration
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 26677103de 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.
- Background: PubMed 23729457Tieu 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.
- Background: PubMed 11411080Andersson 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.
- Background: PubMed 6575989Mueller 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.
- Background: PubMed 6438004Andersson 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.
- Background: PubMed 32644898Oh 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.
- Background: PubMed 26062278Djemal 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.
- Background: PubMed 28247574Mistry 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.
- Individual participant dataSharing planned: No
Related trials for Dental Ankylosis
Not yet recruiting
Risk Factors for Tooth Eruption Diseases
Tooth Eruption Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Huang, DDS, PhD principal investigator
Rutgers School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric Toothbrush-Generated Vibration and Mini-Implant-Assisted Orthodontic Treatment in people with Dental Ankylosis, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the Baseline Ankylosed Tooth Position During 9 Months Period (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05695105, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.