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Vibration + Orthodontic Treatment for Dental Ankylosis
N/A
Recruiting
Led By Wei Huang, DDS, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study Summary
This trial aims to test new methods to treat dental ankylosis, a challenging tooth-bone fusion disorder that can cause developmental bone defects in growing patients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from vibration or orthodontic procedures, irritation at the implant site, typical risks associated with wearing braces such as soreness or minor gum inflammation. Specific side effects will depend on individual reactions to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from the Baseline Alveolar Bone Defect Level of the Ankylosed Tooth During 9 Months Period
Change from the Baseline Ankylosed Tooth Position During 9 Months Period
Secondary outcome measures
Ankylosed Tooth Periodontal Ligament (PDL) Obliteration
Mobility of Ankylosed Tooth
Trial Design
2Treatment groups
Experimental Treatment
Group I: Vibration and Mini-implant GroupExperimental Treatment2 Interventions
For permanent teeth that will receive mini-implant treatment followed by failed toothbrush vibration treatment.
Group II: Vibration GroupExperimental Treatment1 Intervention
For primary and permanent teeth that will receive only toothbrush vibration treatment.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,212 Total Patients Enrolled
Wei Huang, DDS, PhDPrincipal InvestigatorRutgers School of Dental Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My dental treatment with mini-implants, brackets, or wires cannot proceed as planned.I am taking medication that affects my whole body.I am between 6 and 30 years old.I am not fluent in English.I am either male or female.I have no conditions that affect my bleeding or bones.I speak English fluently or as my primary language.I have a tooth that doesn't move and is partly visible in my mouth.
Research Study Groups:
This trial has the following groups:- Group 1: Vibration and Mini-implant Group
- Group 2: Vibration Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age restriction for this medical trial limited to those over 20 years of age?
"As per the study's inclusion criteria, the age range for eligibility is between 6 and 30 years old."
Answered by AI
Is recruitment for this research endeavor still open?
"According to clinicaltrials.gov, the recruitment window for this study has closed as of January 14th 2023. Despite being inactive in terms of recruiting patients, there are other studies on the platform that remain open to applicants at present."
Answered by AI
What criteria must be met for potential participants to qualify for this research project?
"This research is currently admitting 20 individuals diagnosed with ankylosis of their dental structure between the ages of 6 and 30. To meet eligibility requirements, subjects must satisfy the following conditions: providing full informed consent (or assent for minors), being willing to commit to all trial components, identifying as male or female, speaking English fluently, having a clinical diagnosis that includes trauma history, prolonged occlusal contact amongst teeth on either side of the mouth cavity, decreased alveolar bone height due to infra-eruption without mechanical blockage present elsewhere in the jawbone area; lack of mobility upon examination by a dentist or under"
Answered by AI
Who else is applying?
What site did they apply to?
Rutgers School of Dental Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Car accident missing top teeth.
PatientReceived 2+ prior treatments
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