Clinical trial NCT04130477: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Lead sponsor: Harvard School of Dental Medicine
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tunnel attachments as an auxiliary with clear aligners
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1) Horizontal movement in millimeters
timeFrame: 3-12 months of orthodontic treatment
measure: 2) Vertical movement in mm
timeFrame: 3-12 months of orthodontic treatment
measure: 3) angular movement in degrees
timeFrame: 3-12 months of orthodontic treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harvard School of Dental Medicine
name: Mohamed Masoud, BDS, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
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.