Biomarkers of Orthodontic Tooth Movement With Fixed Appliances and Vibration Appliance Therapy

NCT02119455 | Completed Results DMC

• 1 other identifier: OATI-20130635
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Movement

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Tooth Mobility

  Up to Week 17

• Orthodontic Pain Assessment

  Up to Week 17

• Oral Health Quality of Life

  Up to Week 17

Study Arms (2)

Vibration Device+Fixed Appliance Tx

EXPERIMENTAL

Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.

Device: Vibration Device

No Vibration Device+Fixed Appliance Tx

NO INTERVENTION

Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment only and no vibration treatment.

Interventions

Vibration Device DEVICE

Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period.

Vibration Device+Fixed Appliance Tx

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy, non-smoker with no systemic medical conditions and no routine medications
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• OrthoAccel Technologies Inc.: collaborator

Study Sites (1)

University of Connecticut Division of Orthodontics

Farmington, Connecticut, 06030, United States

Location

Related Publications (60)

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  PMID: 32572439 DERIVED

Results Point of Contact

• Title: Dr. Flavio Uribe
• Organization: University of Connecticut- Division of Orthodontics

furibe@uchc.edu

8606792550

Study Officials

• Taranpreet K Chandhoke, DMD, PhD

  UCHC Department of Craniofacial Sciences

  PRINCIPAL INVESTIGATOR

• Flavio A Uribe, DDS, MDentSc

  UCHC Department of Craniofacial Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-12

Locations

US (1)