Tunnel Attachments With Clear Aligners vs Clear Aligners

NCT04130477 | Unknown DMC FDA Device

• 1 other identifier: HarvardSDM
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (3)

• 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: \[(\|predicted-achieved\|/\|predicted\|) 100%\]

  3-12 months of orthodontic treatment

• 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: \[(\|predicted-achieved\|/\|predicted\|) 100%\]

  3-12 months of orthodontic treatment

• 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: \[(\|predicted-achieved\|/\|predicted\|) 100%\]

  3-12 months of orthodontic treatment

Study Arms (2)

Clear aligners with tunnel attachment

EXPERIMENTAL

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

Device: Tunnel attachments and light Nickel Titanium wire

Clear aligners

ACTIVE COMPARATOR

Participants will receive traditional clear aligner therapy with virtual set up

Device: Clear Aligner therapy

Interventions

Tunnel attachments and light Nickel Titanium wire DEVICE

Tunnel attachments planned virtually and light Nickel Titanium wire

Clear aligners with tunnel attachment

Clear Aligner therapy DEVICE

Clear Aligner therapy

Clear aligners

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Dental Medicine: lead

Related Publications (1)

• 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.

  PMID: 30264270 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohamed Masoud, BDS, DMSc

  Harvard School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyaa Aldohan, BDS

CONTACT

8572658533; alyaa_aldohan@hsdm.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontic resident and Doctor of Medical Sciences candidate

Model Details: Tunnel attachments as an auxiliary with clear aligners

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 17, 2019
• Study Start: November 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share