Vibration + Orthodontic Treatment for Dental Ankylosis

Overseen By Julie Chapman-Greene, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Systemic medications

Disqualifiers: Severe ankylosis, Systemic disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to treat dental ankylosis, a condition where a tooth fuses to the bone, preventing proper growth. Researchers are testing two treatments: vibrations from an electric toothbrush and a mini-implant to aid tooth movement. The trial includes two groups; one will receive both treatments, while the other will use only toothbrush vibrations. Individuals with a diagnosed ankylosed tooth affecting daily life, such as causing discomfort or dental issues, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance dental health and quality of life.

Will I have to stop taking my current medications?

The trial excludes participants who are taking any systemic medications, so you would need to stop taking them to participate.

What prior data suggests that these methods are safe for treating dental ankylosis?

Research has shown that electric toothbrushes are safe. Studies have found that toothbrushes with moving and spinning heads effectively reduce plaque and gum disease without major issues. They are widely used and generally well-tolerated by most people.

In contrast, treatments using small implants for braces can cause some discomfort. Patients have reported pain in 40-50% of cases during or after the procedure. However, this pain does not seem to affect overall satisfaction with the treatment.

In summary, both methods have been used safely in different situations. Electric toothbrushes are widely accepted, while mini-implants may cause some discomfort but remain manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for dental ankylosis because they use innovative approaches to address this challenging condition. Unlike traditional methods that might involve surgery or complex orthodontic procedures, this trial explores the use of electric toothbrush-generated vibrations and mini-implant-assisted orthodontic treatments. The vibration technique aims to stimulate the tooth and surrounding bone in a non-invasive manner, potentially making it easier to reposition ankylosed teeth. The mini-implant-assisted approach offers precise control over tooth movement, which could improve treatment outcomes. These methods are promising because they may offer less invasive and more targeted options compared to current standards of care.

What evidence suggests that this trial's treatments could be effective for dental ankylosis?

This trial will compare the effects of electric toothbrush-generated vibration and mini-implant-assisted orthodontic treatment for dental ankylosis. Studies have shown that electric toothbrushes with a back-and-forth rotating motion can reduce gum disease and plaque. This suggests they might also aid in treating dental ankylosis, a condition where a tooth is fused to the bone. Although direct evidence is lacking, the vibration from these toothbrushes might help loosen the tooth from the bone.

In another arm of this trial, research has shown that small implants in orthodontic treatments effectively stabilize teeth. These implants successfully prevent unwanted tooth movement during treatment. This method might address bone issues caused by ankylosis by allowing better control over tooth movement. ^{1 2 3 4 6}

Who Is on the Research Team?

Wei Huang, DDS, PhD

Principal Investigator

Rutgers School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for individuals aged 6-30 with a clinical diagnosis of dental ankylosis, which includes a history of dental trauma, infra-eruption without obstruction, and specific X-ray or CBCT imaging signs. Participants must be English-speaking and able to follow the study's requirements. Pregnant individuals, those not fluent in English, with severe tooth ankylosis, mental disorders affecting compliance, allergies to local anesthesia used here, systemic health issues (affecting bleeding/skeletal health), or who are currently infectious are excluded.

Inclusion Criteria

I have a tooth that doesn't move and is partly visible in my mouth.

I am between the ages of 6 and 30.

Full informed consent and/or informed assent (minors)

Exclusion Criteria

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vibration Treatment

Participants use an electric toothbrush handle to vibrate the ankylosed tooth for 15-60 seconds every day for five days

1 week

1 visit (in-person) at the start, follow-up visits as needed

Mini-implant Treatment

For permanent teeth where vibration treatment fails, a mini-implant is placed for orthodontic treatment

6 weeks

Monthly follow-up visits for up to five months

Follow-up

Participants are monitored for changes in ankylosed tooth position and alveolar bone defect level

9 months

Regular follow-up visits as per outcome measure timeframes

What Are the Treatments Tested in This Trial?

Interventions

• Electric Toothbrush-Generated Vibration
• Mini-Implant-Assisted Orthodontic Treatment

Trial Overview The study tests two new treatments for dental ankylosis: vibrations from electric toothbrushes and mini-implant-assisted orthodontic treatment. The goal is to see if these methods can address the issue where teeth fuse to bone and disrupt normal growth in affected areas.

How Is the Trial Designed?

Group I: Vibration and Mini-implant Group Experimental Treatment 2 Interventions

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

Group II: Vibration Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

In a study involving 23 orthodontic patients, the use of a battery-powered toothbrush to apply vibratory stimulus during canine retraction did not significantly accelerate tooth movement compared to the control side (P = 0.70).

The study lasted for an average of 3 months and involved the use of miniscrews and nickel-titanium springs, but ultimately found that the vibratory stimulus had no beneficial effect on the speed of orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and importance of powered tooth brushes in tooth movement. Kannan, S., Fassul, S., Singh, AK., et al.[2022]

In a randomized clinical trial involving 27 adult patients undergoing Invisalign treatment, the AcceleDent Aura device showed no significant impact on the completion rates of aligners or the final alignment achieved, indicating it may not enhance orthodontic outcomes.

The study also found no significant differences in pain levels, aligner compliance, or quality of life between the group using the AcceleDent device and the sham group, suggesting that the device does not provide additional benefits during orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of supplemental vibration on orthodontic treatment with aligners: A randomized trial. Katchooi, M., Cohanim, B., Tai, S., et al.[2018]

Using an electric toothbrush with a vibration frequency of 150 Hz significantly increased the rate of orthodontic tooth movement (OTM) and levels of prostaglandin E2 (PGE2) compared to a 125 Hz toothbrush and a control group without an electric toothbrush.

The study involved 30 patients aged 18-25, and the results showed that mechanical vibration from the toothbrushes enhanced PGE2 production, which is linked to accelerated tooth movement during orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 125 Hz and 150 Hz vibrational frequency electric toothbrushes on the rate of orthodontic tooth movement and prostaglandin E2 levels. Gujar, AN., Shivamurthy, PG.[2023]

A finite element method study found that using an electric toothbrush with a vibrational frequency of 125-150 Hz applied a force of 15 g, resulting in negligible stress and deflection on teeth and jaw structures, indicating safety for dental health.

The study concluded that this range of vibrational frequency is optimal for electric toothbrushes, as it does not produce harmful effects on the maxilla, mandible, or dentition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 125-150 Hz Vibrational Frequency Electric Toothbrush on Teeth and Supporting Structures: A Finite Element Method Study. Gujar, AN., Shivamurthy, PG., Sabrish, S.[2022]

A systematic review of 6 randomized controlled trials found that vibrational devices generally do not significantly increase the rate of orthodontic tooth movement, with only 1 out of 5 studies showing any benefit.

Additionally, the review indicated that vibrational devices do not effectively reduce pain associated with orthodontic treatment, as 3 studies reported no significant effect on pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibrational devices on orthodontic tooth movement: A systematic review. Aljabaa, A., Almoammar, K., Aldrees, A., et al.[2018]

In a study involving 45 orthodontic patients, low-frequency vibrations used with aligners improved the accuracy of upper incisor rotation compared to a conventional aligner protocol without vibrations.

Replacing aligners every 7 days with low-frequency vibrations did not show significant differences in accuracy compared to replacing them every 14 days, indicating that the vibration protocol can enhance treatment without needing to change the replacement frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does low-frequency vibration have an effect on aligner treatment? A single-centre, randomized controlled trial. Lombardo, L., Arreghini, A., Huanca Ghislanzoni, LT., et al.[2020]

A systematic review of seven studies involving 105 patients using vibrating devices for orthodontic treatment found no significant difference in tooth movement compared to a control group.

The analysis indicates that vibrating devices do not effectively accelerate orthodontic tooth movement, suggesting they may not be a beneficial addition to orthodontic treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of using a Vibrating Device in Accelerating Orthodontic Tooth Movement: A Systematic Review and Meta-Analysis. Elmotaleb, MAA., Elnamrawy, MM., Sharaby, F., et al.[2022]

The systematic review found that oscillating-rotating powered brushes are generally safe for both soft and hard tissues in the mouth when compared to manual toothbrushes, indicating they can be a reliable option for oral hygiene.

This review is based on high-quality evidence, providing strong recommendations for the use of powered brushes, supported by funding from a reputable industry source.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There is no difference with regard to hard and/or soft tissue safety between oscillating-rotating powered brushes and manual toothbrushes. Farsi, NJ., Nicolau, B.[2013]

Powered toothbrushes are effective in promoting periodontal health during orthodontic treatment, as shown by a systematic review and meta-analysis of various studies.

The review highlights both short-term and long-term benefits of using powered toothbrushes, suggesting they can be a valuable tool for patients undergoing orthodontic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insufficient Evidence within a Systematic Review and Meta-Analysis of Powered Toothbrushes over Manual Toothbrushes for Soft Tissue Health During Orthodontic Treatment. Tilliss, T., Carey, CM.[2019]

In a case series involving five orthodontic patients aged 9 to 22, the Oral-B iO oscillating-rotating electric toothbrush with the Targeted Clean brush head significantly reduced plaque accumulation by 15% to 45% over a 9 to 14-week period.

Patients reported increased motivation to brush their teeth, and both patients and caregivers expressed satisfaction with the toothbrush, indicating its effectiveness and acceptability for improving oral hygiene in orthodontic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an Oscillating-Rotating Electric Toothbrush and Novel Brush Head to Increase Brushing Motivation and Reduce Plaque Among Orthodontic Patients. Van Elslande, D.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05695105?cond=Ankylosis&viewType=Table&rank=1

NCT05695105 | Novel 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10084121/

The efficacy of an oscillating‐rotating power toothbrush ... What is the efficacy of oscillating‐rotating power toothbrush compared to high‐frequency sonic power toothbrush in improving parameters of dental plaque and ...

3. amjdent.com amjdent.com/Archive/ReviewArticles/2020/Grender%20AJD%20Feb%202020.pdf

The effects of oscillating-rotating electric toothbrushes on ... Results from clinical trials included in the bleeding sites meta-analysis: Oral-B oscillating-rotating (O-R) toothbrush versus side-to-side (sonic) toothbrush.

4. dentalcare.com dentalcare.com/en-us/featured-dental-research/oral-b-oscillating-rotating-electric-toothbrushes

Oral-B Oscillating Rotating Electric Toothbrushes The list below features several recent peer-reviewed publications supporting the effectiveness and safety of Oral-B iO and other Oral-B oscillating-rotating ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9379213/

Evaluation of an oscillating-rotating toothbrush with micro- ... Use of a novel O-R electric toothbrush with micro-vibrations produced improved reduction of gingivitis and plaque over an 8-week period in adult subjects with ...

6. mdpi.com mdpi.com/2076-3417/13/1/18

Effectiveness of Oscillating and Rotating versus High- ... The findings of this proof-of-concept study showed the effectiveness over a 3-month period of both oscillating-rotating and sonic PTB in terms of oral health ...