A randomized trial on the effects of root resorption after orthodontic treatment using pulsating force

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RESEARCH ARTICLE

Open Access

A randomized trial on the effects of root resorption after orthodontic treatment using pulsating force Jue Wang1, Ejvis Lamani1, Terpsithea Christou1, Peng Li2 and Chung How Kau1*

Abstract Background: An orthodontic device that moves teeth with pulsating force was invented and underwent a single center, controlled, clinical trial to test its safety and efficacy for treatment. The device has a custom-made thermoplastic mouthpiece which fits over the teeth with an inflatable silicone element. A console that measures and controls the pulsating force level in real-time controls the air pressure that delivers a pulsating force. In this study, the effect of the device on root resorption during orthodontic treatment was evaluated using 3D cone beam computed tomography and compared with a control group of patients who received Invisalign treatment. Methods: Twenty-eight subjects were enrolled in the investigational arm and 15 in the control group. Subjects were followed until the average score of the mandibular and maxillary teeth achieved a Little’s Irregularity Index of 1.5 mm or less. Results: There were no adverse events reported throughout the study for either treatment arm. No clinically significant root resorption was observed for either group. The investigational device did not cause root resorption greater than the control group. Both devices produced a safety profile compared to current orthodontic techniques. Conclusion: The investigational device did not produce more root resorption than similar conventional orthodontic appliances. Trial registration: ClinicalTrials.gov, NCT03421886. Registered 12 January 2018 - Retrospectively registered. Keywords: Radiographic evaluation, Root-crown ratios, Clear aligners, Tooth movement, Cone beam computed tomography

Background Efforts have been continuously made in the orthodontic field to provide a more effective, esthetic, and comfortable ways of treatment for orthodontic patients. Optimum orthodontic force is critical for the effectiveness and efficiency of orthodontic treatment. However, monitoring the magnitude of the orthodontic force * Correspondence: [email protected] 1 Department of Orthodontics, School of Dentistry, Univeristy of Alabama at Birmingham, Room 305, School of Dentistry Building, 1919 7th Avenue South, Birmingham, AL 35294, USA Full list of author information is available at the end of the article

applied by current orthodontic appliances is difficult. Uncontrolled orthodontic force can collapse blood vessels within the periodontal ligament (PDL) leading to undesirable side effects. The cycle of PDL damage (hyalinized area formation and later undermining bone resorption) and repair is usually the main reason for prolonged orthodontic treatment and root damage. Both in vitro and in vivo studies have shown that fully controlled pulsating orthodontic force can shorten the treatment period by potentially preventing the damage to capillary vessels within the PDL [1–4]. The effect of intermittent force versus continuous force on