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Effect of Mechanical Vibration on Root Resorption

Primary Purpose

Vibration; Exposure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mechanical Vibration
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vibration; Exposure

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Need for bilateral maxillary first premolar extractions (necessitating moderate anchorage) and fixed appliance treatment
  • Permanent dentition
  • Completion of apexification
  • Similar minimal crowding on each side of the maxillary arch

Exclusion Criteria:

  • Previous orthodontic or orthopedic treatment
  • Unilateral or bilateral posterior crossbites
  • Craniofacial anomaly
  • History of trauma, bruxism, or parafunction
  • Past or present signs and symptoms of periodontal disease
  • Significant medical history that would affect the development or structure of the teeth and jaws and any subsequent tooth movement
  • History of asthma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    No-force group

    Force Group

    Arm Description

    The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction on one side and the other side was used as the premolar tooth control group. Oral B HummingBird device (Procter&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks. At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.

    The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction to one side and the other side was used as the premolar tooth control group. As in no-force group, same device procedure was used for the application of vibration. Self-ligating Speed (Strite Industries, Cambridge, Ontario, Canada) tubes and brackets with 0.022×0.026 inch slots were bonded to the buccal surfaces of the right and left first molar teeth and first premolar teeth.150g of buccally directed forces, producing by a 0.017×0.025-in beta-titanium-molybdenum alloy (3M Unitek, Monrovia, Calif) cantilever spring, were applied to premolar teeth on both side.The force magnitude was measured with a strain gauge (Dentaurum). At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.

    Outcomes

    Primary Outcome Measures

    Orthodontically induced inflammatory root resorption (OIIRR)
    Orthodontically induced inflammatory root resorption (OIIRR) or, as it is better known, root resorption, is an unavoidable pathologic consequence of orthodontic tooth movement. It is a certain adverse effect of an otherwise predictable force application.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 17, 2020
    Last Updated
    December 22, 2020
    Sponsor
    Yeditepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04686617
    Brief Title
    Effect of Mechanical Vibration on Root Resorption
    Official Title
    The Effect of Twelve Weeks of Mechanical Vibration on Root Resorption: A Micro-Ct Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2013 (Actual)
    Primary Completion Date
    June 1, 2015 (Actual)
    Study Completion Date
    July 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yeditepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study was to investigate the effect of mechanical vibration on root resorption with or without the application of orthodontic force. Twenty patients who required maxillary premolar extractions as part of their orthodontic treatment were randomly separated into two groups of 10: no-force group and force group. Using a split-mouth procedure, each patient's maxillary first premolar teeth were randomly assigned as either vibration or control side in both groups. Buccally directed vibration of 113 Hz, using an Oral-B HummingBird device with a modified tip, was applied to the maxillary first premolar for 10 mins/day during 12 weeks. After the force application period, the maxillary first premolars were extracted and scanned with micro-computed tomography. Fiji(ImageJ) which made slice-by-slice quantitative volumetric measurements was used for resorption crater calculation. Total crater volumes was compared with Wilcoxon and Mann-Whitney U tests.
    Detailed Description
    The sample included 40 maxillary first premolars from 20 orthodontic patients (7 boys and 13 girls; range: 15.08-18.58 years; mean: 16.77 years) who required bilateral maxillary first premolar extractions as part of their orthodontic treatment. They were recruited according to strict selection criteria as described previously.These included need for bilateral maxillary first premolar extractions (necessitating moderate anchorage) and fixed appliance treatment; permanent dentition; completion of apexification; similar minimal crowding on each side of the maxillary arch; no previous orthodontic or orthopedic treatment; no unilateral or bilateral posterior crossbites; no craniofacial anomaly; no history of trauma, bruxism, or parafunction; no past or present signs and symptoms of periodontal disease; no significant medical history that would affect the development or structure of the teeth and jaws and any subsequent tooth movement; and no history of asthma. The sample size was calculated by using Piface 1.72, and guaranteed 82.56% power. This number was reached by considering the standard deviation of 0.46mm3 in our previous similar study. True difference of means was estimated at 0.2mm3, and type I error(α) was accepted as the standard value .05. Ethics approval was obtained from the Ethics Committee of Bulent Ecevit University (2012/23). All subjects and their guardians consented to participate in this study after receiving verbal and written explanations. Impressions were taken with alginate of the maxillary jaw only to construct the appliance. The study model was obtained by pouring hard plaster. On this model, the transpalatal arch was formed by bending a 0.09 mm steel wire between the maxillary right and left first molar teeth. To prevent potential contact of the teeth during buccal movement to the transpalatal arch, occlusion rising acrylic plates were added. The acrylic plates were of mean 2mm thickness to only include occlusion of the first molar teeth. After fitting the transpalatal arches in the mouth, light-cured glass ionomer cement (TransbondTM Plus, 3M Unitek, Monrovia, USA) was applied to the maxillary first molar teeth of all the patients. After these procedures, the patients were randomly separated into 2 equal groups. Randomization was made using the Excel program (Microsoft, Redmond, WA, USA), and allocation was hidden in consecutively numbered, closed envelopes. Blinding was used for treatment and outcome assessments. No-force group: The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction on one side and the other side was used as the premolar tooth control group. Oral B Hummingbird device (Procter&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks. At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted. Force group: The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction to one side and the other side was used as the premolar tooth control group. As in no-force group, same device procedure was used for the application of vibration. Self-ligating Speed (Strite Industries, Cambridge, Ontario, Canada) tubes and brackets with 0.022×0.026 inch slots were bonded to the buccal surfaces of the right and left first molar teeth and first premolar teeth.150g of buccally directed forces, producing by a 0.017×0.025-in beta-titanium-molybdenum alloy (3M Unitek, Monrovia, Calif) cantilever spring, were applied to premolar teeth on both side. The force magnitude was measured with a strain gauge (Dentaurum). At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted. The premolar teeth were extracted under local anesthesia by the same dental practitioner in all cases. To remove blood and tissue remnants from the teeth after extraction, they were washed with non-pressurized isotonic solution without touching the root surfaces, then each tooth was placed in a 5 ml sterile tube containing 10% formalin solution (Sarstedt Ag & Co., Nümbrecht, Germany). After 2 weeks the formalin solution was changed and no other procedure was applied until examination of the roots. Scanning of the root surfaces was applied using the SkyScan-1172 x-ray micro-tomography device (SkyScan, Aartselaar, Belgium). To calculate the volume of the resorption craters isolated on the axial slices, open-source Fiji (ImageJ) software was used. Using the convex hull module in the software, a line was drawn joining the edges of the resorption craters and the area below the line was calculated as the volume (Figure 4). Volumetric changes in the craters on the root surfaces were evaluated both locally and totally. The data were statistically analyzed using SPSS version 24.0(IBM Corp., Armonk, NY, USA). The Shapiro-Wilk test was used to test for normal distribution. Wilcoxon test was applied to the within-group comparisons of the resorption volumes formed at different levels(cervical, mid, apical) on different surfaces of the root(buccal, palatal, mesial, and distal). The Mann-Whitney U-test was used in comparisons between the groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vibration; Exposure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No-force group
    Arm Type
    No Intervention
    Arm Description
    The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction on one side and the other side was used as the premolar tooth control group. Oral B HummingBird device (Procter&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks. At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.
    Arm Title
    Force Group
    Arm Type
    Active Comparator
    Arm Description
    The right and left side first premolar teeth were randomly assigned (split-mouth design) so that mechanical vibration was applied in the buccal direction to one side and the other side was used as the premolar tooth control group. As in no-force group, same device procedure was used for the application of vibration. Self-ligating Speed (Strite Industries, Cambridge, Ontario, Canada) tubes and brackets with 0.022×0.026 inch slots were bonded to the buccal surfaces of the right and left first molar teeth and first premolar teeth.150g of buccally directed forces, producing by a 0.017×0.025-in beta-titanium-molybdenum alloy (3M Unitek, Monrovia, Calif) cantilever spring, were applied to premolar teeth on both side.The force magnitude was measured with a strain gauge (Dentaurum). At the end of the 12th week, the first stage was completed and the first premolar teeth were extracted.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Mechanical Vibration
    Intervention Description
    Oral B HummingBird device (Procter&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks.
    Primary Outcome Measure Information:
    Title
    Orthodontically induced inflammatory root resorption (OIIRR)
    Description
    Orthodontically induced inflammatory root resorption (OIIRR) or, as it is better known, root resorption, is an unavoidable pathologic consequence of orthodontic tooth movement. It is a certain adverse effect of an otherwise predictable force application.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Need for bilateral maxillary first premolar extractions (necessitating moderate anchorage) and fixed appliance treatment Permanent dentition Completion of apexification Similar minimal crowding on each side of the maxillary arch Exclusion Criteria: Previous orthodontic or orthopedic treatment Unilateral or bilateral posterior crossbites Craniofacial anomaly History of trauma, bruxism, or parafunction Past or present signs and symptoms of periodontal disease Significant medical history that would affect the development or structure of the teeth and jaws and any subsequent tooth movement History of asthma

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    We can share when it's really needed.
    Citations:
    PubMed Identifier
    29602338
    Citation
    DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N, Slipper C, Grant J, Alsaleh M, Khaja Y, Cobourne MT. Effects of supplemental vibrational force on space closure, treatment duration, and occlusal outcome: A multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2018 Apr;153(4):469-480.e4. doi: 10.1016/j.ajodo.2017.10.021.
    Results Reference
    background
    PubMed Identifier
    28743370
    Citation
    Liao Z, Elekdag-Turk S, Turk T, Grove J, Dalci O, Chen J, Zheng K, Ali Darendeliler M, Swain M, Li Q. Computational and clinical investigation on the role of mechanical vibration on orthodontic tooth movement. J Biomech. 2017 Jul 26;60:57-64. doi: 10.1016/j.jbiomech.2017.06.012. Epub 2017 Jun 21.
    Results Reference
    background

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    Effect of Mechanical Vibration on Root Resorption

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