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
About this trial
This is an interventional treatment trial for Malocclusion
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
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
NCT ID
NCT04130477
First Posted
October 10, 2019
Last Updated
October 15, 2019
Sponsor
Harvard School of Dental Medicine
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
Related Info
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Tunnel Attachments With Clear Aligners vs Clear Aligners
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