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Tunnel Attachments With Clear Aligners vs Clear Aligners

Primary Purpose

Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tunnel attachments and light Nickel Titanium wire
Clear Aligner therapy
Sponsored by
Harvard School of Dental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. healthy subjects over the age of 10 years and below 65;
  2. eruption of all permanent anterior teeth;
  3. non-extraction treatment;
  4. maximum of 7mm of crowding/spacing;
  5. no more than 45 degrees of rotations
  6. no more than 7 mm crowding

Exclusion Criteria:

  1. presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars), congenitally missing lateral incisors, and tumors of the parathyroid gland;
  2. the presence of bridges or implants replacing anterior teeth;
  3. cases requiring orthognathic surgery;
  4. significant (> moderate) periodontal disease, intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal Anti-Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class), pregnancy;
  5. cases requiring tooth extractions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Clear aligners with tunnel attachment

    Clear aligners

    Arm Description

    Participants will receive traditional clear aligner therapy with virtual set up and will be supplemented by virtually planned tunnel attachments which will be threaded by a light Nickel-Titanium wire

    Participants will receive traditional clear aligner therapy with virtual set up

    Outcomes

    Primary Outcome Measures

    1) Horizontal movement in millimeters
    The virtual setups (predicted results) and actual results scans will be superimposed using a best-fit alignment method using Geomagic Control X (3D Systems, Rock Hill, South Carolina). Initial alignment will be done using 300 surface points, and fine adjustments will be made using additional 1500 points. This process will be repeated as necessary. Once satisfactory superimposition is performed, the x, y, z coordinates (mm) of dental landmarks on the setup and result arches will be exported and analyzed. Linear and angular measurements will be made to determine the accuracy of each system in achieving predicted vertical, in-out and torque treatment outcomes. The percentage of accurate tooth movement will be determined with the following equation: [(|predicted-achieved|/|predicted|) 100%]
    2) Vertical movement in mm
    The virtual setups (predicted results) and actual results scans will be superimposed using a best-fit alignment method using Geomagic Control X (3D Systems, Rock Hill, South Carolina). Initial alignment will be done using 300 surface points, and fine adjustments will be made using additional 1500 points. This process will be repeated as necessary. Once satisfactory superimposition is performed, the x, y, z coordinates (mm) of dental landmarks on the setup and result arches will be exported and analyzed. Linear and angular measurements will be made to determine the accuracy of each system in achieving predicted vertical, in-out and torque treatment outcomes. The percentage of accurate tooth movement will be determined with the following equation: [(|predicted-achieved|/|predicted|) 100%]
    3) angular movement in degrees
    The virtual setups (predicted results) and actual results scans will be superimposed using a best-fit alignment method using Geomagic Control X (3D Systems, Rock Hill, South Carolina). Initial alignment will be done using 300 surface points, and fine adjustments will be made using additional 1500 points. This process will be repeated as necessary. Once satisfactory superimposition is performed, the x, y, z coordinates (mm) of dental landmarks on the setup and result arches will be exported and analyzed. Linear and angular measurements will be made to determine the accuracy of each system in achieving predicted vertical, in-out and torque treatment outcomes. The percentage of accurate tooth movement will be determined with the following equation: [(|predicted-achieved|/|predicted|) 100%]

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2019
    Last Updated
    October 15, 2019
    Sponsor
    Harvard School of Dental Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04130477
    Brief Title
    Tunnel Attachments With Clear Aligners vs Clear Aligners
    Official Title
    Computer Designed and Chairside Fabricated Custom Tunnel Attachments Paired With Clear Aligners Versus Traditional Clear Aligners for Orthodontic Leveling and Aligning- A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    April 30, 2021 (Anticipated)
    Study Completion Date
    May 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard School of Dental Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Incorporating wire threaded custom tunnel attachments with clear aligner therapy is a novel approach developed to address the shortcomings of the currently available orthodontic systems. This hybrid system is anticipated to take advantage of the benefits and overcome many of the limitations of traditional fixed buccal/lingual appliances and clear aligner therapy. The concept utilizes light arch wires to be threaded through computer designed, chairside-fabricated composite tunnel attachments to achieve better control of three-dimensional tooth movements not achievable by clear aligners, such as Invisalign® (Align Technology, Santa Clara, CA) alone. The superelastic feature of the arch wires allows delivery of more continuous forces than aligners alone, potentially permitting shorter duration of recommended aligner wear during orthodontic treatment. A virtual set-up would be used to plan the desired position of the teeth, which in turn will be used to customize the size and position of composite tunnel attachments based on how two round arch wires will pass through tubes within the attachments. The attachments can be placed on either the buccal or lingual surfaces of teeth, depending on clinical preferences and esthetic demands. This is achievable using in-house aligners, which will also allow the fabrication of aligners in the office or at a conventional orthodontic lab at a fraction of the cost of traditional clear aligners.
    Detailed Description
    Specific aims: Test and formally describe a novel method that utilizes clear aligners paired with computer-designed, chairside-fabricated tunnel attachments to achieve tooth movements that are challenging for clear aligners. Conduct a randomized clinical trial to compare the ability of a traditional clear aligner system Invisalign® (Align Technology, Santa Clara, CA) and a clear aligner system incorporating wire threaded tunnel attachments in: achieving predicted outcomes; discrepancies in bucco-lingual and inciso-gingival positions between the virtual plan and end of treatment intraoral scan and will be measured in millimeters and angular discrepancies will be measured in degrees end of treatment ABO leveling and alignment objective grading scores Materials and Methods: A virtual set-up is completed by the clinician to plan the position, orientation, and dimension will be customized on the teeth to be moved.Generally, they are spherically shaped and their dimensions are approximately 2-3 mm. Vacuum-formed attachment template will be made to take the shape of a tube-holding spheres, in which tubes are embedded. The tubes are standard in size with an outside diameter of 0.032", and an inside diameter of 0.019" and 2 mm length The template will be loaded with composite after inserting the metal tubes are placed in their predetermined location on the tray. Double tubes will be used when torque control is needed. 0.016" buccal or lingual round wires will be placed into the tunnel attachments along the attachments. Aligners will be delivered to patient to be worn for at least 8 hours a day and changed as determined by the Dental Monitoring application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malocclusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Tunnel attachments as an auxiliary with clear aligners
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clear aligners with tunnel attachment
    Arm Type
    Experimental
    Arm Description
    Participants will receive traditional clear aligner therapy with virtual set up and will be supplemented by virtually planned tunnel attachments which will be threaded by a light Nickel-Titanium wire
    Arm Title
    Clear aligners
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive traditional clear aligner therapy with virtual set up
    Intervention Type
    Device
    Intervention Name(s)
    Tunnel attachments and light Nickel Titanium wire
    Intervention Description
    Tunnel attachments planned virtually and light Nickel Titanium wire
    Intervention Type
    Device
    Intervention Name(s)
    Clear Aligner therapy
    Intervention Description
    Clear Aligner therapy
    Primary Outcome Measure Information:
    Title
    1) Horizontal movement in millimeters
    Description
    The virtual setups (predicted results) and actual results scans will be superimposed using a best-fit alignment method using Geomagic Control X (3D Systems, Rock Hill, South Carolina). Initial alignment will be done using 300 surface points, and fine adjustments will be made using additional 1500 points. This process will be repeated as necessary. Once satisfactory superimposition is performed, the x, y, z coordinates (mm) of dental landmarks on the setup and result arches will be exported and analyzed. Linear and angular measurements will be made to determine the accuracy of each system in achieving predicted vertical, in-out and torque treatment outcomes. The percentage of accurate tooth movement will be determined with the following equation: [(|predicted-achieved|/|predicted|) 100%]
    Time Frame
    3-12 months of orthodontic treatment
    Title
    2) Vertical movement in mm
    Description
    The virtual setups (predicted results) and actual results scans will be superimposed using a best-fit alignment method using Geomagic Control X (3D Systems, Rock Hill, South Carolina). Initial alignment will be done using 300 surface points, and fine adjustments will be made using additional 1500 points. This process will be repeated as necessary. Once satisfactory superimposition is performed, the x, y, z coordinates (mm) of dental landmarks on the setup and result arches will be exported and analyzed. Linear and angular measurements will be made to determine the accuracy of each system in achieving predicted vertical, in-out and torque treatment outcomes. The percentage of accurate tooth movement will be determined with the following equation: [(|predicted-achieved|/|predicted|) 100%]
    Time Frame
    3-12 months of orthodontic treatment
    Title
    3) angular movement in degrees
    Description
    The virtual setups (predicted results) and actual results scans will be superimposed using a best-fit alignment method using Geomagic Control X (3D Systems, Rock Hill, South Carolina). Initial alignment will be done using 300 surface points, and fine adjustments will be made using additional 1500 points. This process will be repeated as necessary. Once satisfactory superimposition is performed, the x, y, z coordinates (mm) of dental landmarks on the setup and result arches will be exported and analyzed. Linear and angular measurements will be made to determine the accuracy of each system in achieving predicted vertical, in-out and torque treatment outcomes. The percentage of accurate tooth movement will be determined with the following equation: [(|predicted-achieved|/|predicted|) 100%]
    Time Frame
    3-12 months of orthodontic treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy subjects over the age of 10 years and below 65; eruption of all permanent anterior teeth; non-extraction treatment; maximum of 7mm of crowding/spacing; no more than 45 degrees of rotations no more than 7 mm crowding Exclusion Criteria: presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars), congenitally missing lateral incisors, and tumors of the parathyroid gland; the presence of bridges or implants replacing anterior teeth; cases requiring orthognathic surgery; significant (> moderate) periodontal disease, intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal Anti-Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class), pregnancy; cases requiring tooth extractions
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alyaa Aldohan, BDS
    Phone
    8572658533
    Email
    alyaa_aldohan@hsdm.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Masoud, BDS, DMSc
    Organizational Affiliation
    Harvard School of Dental Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30264270
    Citation
    Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z.
    Results Reference
    result
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/?term=Papadimitriou%2C+A.%2C+et+al.%2C+Clinical+effectiveness+of+Invisalign(R)+orthodontic+treatment%3A+a+systematic+review
    Description
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