Tooth Movement Clinical Trial
Official title:
Biomarkers of Orthodontic Tooth Movement With Fixed Appliances and Vibration Appliance Therapy: A Randomized Clinical Trial
NCT number | NCT02119455 |
Other study ID # | OATI-20130635 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | June 2018 |
Verified date | December 2019 |
Source | UConn Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Currently, orthodontic treatment typically lasts approximately 2 years. There are a number of
advantages for reducing the duration of treatment, including reducing the potential risk of
caries, root resorption and for minimizing patient "burn out" from prolonged treatment.
While some evidence does exist that vibration may accelerate the speed of tooth movement, the
biological mechanism is still unknown. Identification of specific factors involved in tooth
movement that are further stimulated by vibration would help to understand the mechanisms
involved as well as discover possible biologic targets which could be utilized or modified to
maximize the benefits of vibration treatment.
The purpose of this study is to identify novel biological factors that are expressed in
patients undergoing orthodontic tooth movement in conjunction with vibration appliance
therapy.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 15 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Healthy, non-smoker with no systemic medical conditions and no routine medications - 15 to 35 years of age at the time of bonding - Non-extraction treatment plan or no extractions required in the first 6 months of treatment - At least 5mm of crowding in the mandibular arch - Full-complement dentition 1st molar to 1st molar - Good oral hygiene Exclusion Criteria: - Patients that require extractions as part of the orthodontic plan - Smoking or excessive alcohol consumption - Patients with edentulous areas - Evidence of periodontal disease (any pocket depths more than 4mm) - Use of anti-inflammatory drugs within 2 days of bonding - Active oral lesions (ulcerations, sores, mucositis, etc.) - Uncontrolled diabetes - Dentofacial deformities (cleft palate, hemifacial microsomia, etc.) - Subjects routinely taking any of the following medications: - Corticosteroids (including for asthma) - Bisphosphonates - Anti-inflammatories - Nicotine Patch - Estrogen - Opioids - Growth Hormone - Relaxin - Anti-coagulants - Disease that could affect bone metabolism: - Parathyroid or thyroid dysfunction - Osteoporosis, osteomalacia - Vitamin D deficiency - Fibrous dysplasia - Paget's Disease - Multiple Myeloma - Osteogenesis Imperfecta - History of Bone Metastasis - Patients taking medications such as bisphosphonates, corticosteroids or any anti-inflammatory drug |
Country | Name | City | State |
---|---|---|---|
United States | University of Connecticut Division of Orthodontics | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
UConn Health | OrthoAccel Technologies Inc. |
United States,
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* Note: There are 59 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the Expression of Salivary Biomarkers of Bone Remodeling | Saliva will be collected as T0 (Baseline), T1 (5-6 weeks), T2 (10-12 weeks), T3 (15-17 weeks). Saliva will be analysed for a variety of biomarkers with protein quantified by ELISA assay at each time point for each subject. | Up to Week 17 of alignment (From T0 to T3) | |
Primary | Alignment of Mandibular Anterior Teeth | At each study visit, alginate impressions will be taken on each subject. These models will be analyzed by 2 examiners to calculate the alignment based on Little's Irregularity Index. Measure Description: Little's Irregularity index measures the interproximal contact displacement in mm between the anterior teeth segment from the mesial of the canine on one side to the mesial aspect of the contralateral canine. | Up to Week 17 | |
Secondary | Tooth Mobility | The degree of tooth mobility will be used using a Periotest device (Siemens, Bensheim, Germany) on the central incisors, canines and 2nd premolars in both mandibular quadrants as previously described by Liou et al. The archwire will be removed and the Periotest measurements will be taken in triplicate, with means recorded. The Periotest's scale ranges from -8 to +50. The lower the Periotest value, the higher is the stability / damping effect of the test object (tooth or implant). -8 to 0 indicates high stability with minimal movement, +1-+9 indicates some degree of mobility (moderate) and +10 to +50 indicates severe mobility. | Up to Week 17 | |
Secondary | Orthodontic Pain Assessment | Subjects will be given a pain diary on the baseline (T0), visits T1 & T2 to record the level of orthodontic pain each evening for the first 7 days after each study visit. The degree of pain was assessed using a metric Visual Analog Scale. The patient was given a scale that was a 100 mm in length. At 0 mm on the scale line, the pain level would be "0" indicating no pain. At the higher end of the line scale (the 100 mm mark), the pain level was considered the most severe. Data presented here indicates the mean VAS scores in mm for the 1st week following each study visit. The average values indicate the measure along the scale. | Up to Week 17 | |
Secondary | Oral Health Quality of Life | To assess the impact of the vibration appliance on the overall oral health quality of life of the subject, subjects will be given an Oral Health Impact Profile (OHIP-14) questionnaire. The OHIP-14 consists of 14 question areas divided into specific dimensions including functional limitation, physical pain, psychological discomfort, physical disability, psychological and social disability and overall life handicap from orthodontic treatment with or without the vibration appliance. For the OHIP questionnaire, responses are coded 0 (never or not applicable), 1 (hardly ever), 2 (occasionally), 3 (fairly often) or 4 (very often). As a general rule, the greater the OHIP score, the more of an impact a particular intervention had on the patient's overall quality of life. The scores for the overall OHIP-14 range from 0-56, with values closer to 0 indicating minimal impact on quality of life and values closer to 56 indicating great impact on quality of life. | Up to Week 17 |
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