title: Effect of supplemental vibrational force on orthodontically induced inflammatory root resorption: A multicenter randomized clinical trial.
abstract: BACKGROUND
  A multicenter parallel 3-arm randomized clinical trial was carried out in 1 university and 2 district hospitals in the United Kingdom to investigate the effect of supplemental vibrational force on orthodontically induced inflammatory root resorption (OIIRR) during the alignment phase of fixed appliance therapy.
  
  
  METHODS
  Eighty-one subjects less than 20 years old with mandibular incisor irregularity undergoing extraction-based fixed-appliance treatment were randomly allocated to supplementary (20 minutes a day) use of an intraoral vibrational device (AcceleDent; OrthoAccel Technologies, Houston, Tex) (n = 29), an identical nonfunctional (sham) device (n = 25), or fixed appliances only (n = 27). OIIRR was measured blindly from long-cone periapical radiographs of the maxillary right central incisor taken at the start of treatment and the end of alignment when a 0.019 × 0.025-in stainless steel archwire was placed (mean follow-up, 201.6 days; 95% confidence interval [CI], 188.6-214.6 days). Data were analyzed blindly on a per-protocol basis because losses to follow-up were minimal, with descriptive statistics, 1-way analysis of variance, and univariable and multivariable regression modeling.
  
  
  RESULTS
  Nine patients were excluded from the analysis; they were evenly distributed across the groups. Mean overall OIIRR measured among the 72 patients was 1.08 mm (95% CI, 0.89-1.27 mm). Multivariable regression indicated no significant difference in OIIRR for the AcceleDent (difference, 0.22 mm; 95% CI, -0.14-0.72; P = 0.184) and AcceleDent sham groups (difference, 0.29 mm; 95% CI, -0.15-0.99; P = 0.147) compared with the fixed-appliance-only group, after accounting for patient sex, age, malocclusion, extraction pattern, alignment time, maximum pain experienced, history of dentoalveolar trauma, and initial root length of the maxillary right central incisor. No other side-effects were recorded apart from pain and OIIRR.
  
  
  CONCLUSIONS
  The use of supplemental vibrational force during the alignment phase of fixed appliance orthodontic treatment does not affect OIIRR associated with the maxillary central incisor.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT02314975).
  
  
  METHODS
  The protocol was not published before trial commencement.
  
  
  BACKGROUND
  Functional and sham AcceleDent units were donated by the manufacturer; there was no contribution to the conduct or the writing of this study.
authors.affiliation: Consultant, Department of Orthodontics, William Harvey Hospital, East Kent Hospitals University NHS Foundation Trust, Ashford, United Kingdom.
authors.forename: Andrew T
authors.initials: AT
authors.lastname: DiBiase
authors.affiliation: Postgraduate student, Department of Orthodontics, King's College London Dental Institute, London, United Kingdom.
authors.forename: Neil R
authors.initials: NR
authors.lastname: Woodhouse
authors.affiliation: Postgraduate student, Department of Orthodontics and postdoctoral fellow, Department of Oral Technology; School of Dentistry, University of Bonn, Bonn, Germany.
authors.forename: Spyridon N
authors.initials: SN
authors.lastname: Papageorgiou
authors.affiliation: Consultant, Department of Orthodontics, Royal Alexandra Children's Hospital, Brighton and Sussex University Hospitals NHS Foundation Trust, Brighton, United Kingdom.
authors.forename: Nicola
authors.initials: N
authors.lastname: Johnson
authors.affiliation: Consultant, Department of Orthodontics, Royal Alexandra Children's Hospital, Brighton and Sussex University Hospitals NHS Foundation Trust, Brighton, United Kingdom.
authors.forename: Carmel
authors.initials: C
authors.lastname: Slipper
authors.affiliation: Consultant, Department of Orthodontics, Royal Alexandra Children's Hospital, Brighton and Sussex University Hospitals NHS Foundation Trust, Brighton, United Kingdom.
authors.forename: James
authors.initials: J
authors.lastname: Grant
authors.affiliation: Postgraduate student, Department of Orthodontics, King's College London Dental Institute, London, United Kingdom.
authors.forename: Maryam
authors.initials: M
authors.lastname: Alsaleh
authors.affiliation: Professor, Department of Orthodontics, King's College London Dental Institute, Hon consultant in orthodontics, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom. Electronic address: martyn.cobourne@kcl.ac.uk.co.uk.
authors.forename: Martyn T
authors.initials: MT
authors.lastname: Cobourne
mesh_terms: D000293:Adolescent; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D012391:Root Resorption / Q000209:etiology* / Q000517:prevention & control; D014087:Tooth Movement Techniques / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D014732:Vibration / Q000627:therapeutic use*; D055815:Young Adult