N/A N=40 Randomized Single-blind Treatment

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

Tooth Movement

Bottom Line

View on ClinicalTrials.gov: NCT02119455 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Changes in the Expression of Salivary Biomarkers of Bone Remodeling — -1.62; 0.5; -1.95; 0.47 pg/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vibration Device (Device)
Age: Pediatric, Adult · 15+ yrs
Sex: Male
Sponsor: UConn Health
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in the Expression of Salivary Biomarkers of Bone Remodeling	-1.62; 0.5; -1.95; 0.47; -17957.59; 6783.71	—
PRIMARY Alignment of Mandibular Anterior Teeth	6.49; 7.47	—
SECONDARY Tooth Mobility	2.34; 2.42	—
SECONDARY Orthodontic Pain Assessment	33.11; 35.25; 13.92; 14.4; 24.12; 27.66	—
SECONDARY Oral Health Quality of Life	4.5; 5.94; 5.56; 6.12; 4.4; 4.91	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02119455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.