MalocclusionNCT04130477
Tunnel Attachments With Clear Aligners vs Clear Aligners
A study testing Tunnel attachments and light Nickel Titanium wire and Clear Aligner therapy in people with Malocclusion, run by Harvard School of Dental Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Tunnel attachments and light Nickel Titanium wire and Clear Aligner therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Malocclusion
- Being tested
- Tunnel attachments and light Nickel Titanium wire, Clear Aligner therapy
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunnel attachments and light Nickel Titanium wireDevice
Tunnel attachments planned virtually and light Nickel Titanium wire
Clear Aligner therapyDevice
Clear Aligner therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Tunnel attachments and light Nickel Titanium wire |
| Clear aligners | Active comparator | Participants will receive traditional clear aligner therapy with virtual set up Receives: Device: Clear Aligner therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%]
Measured: 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%]
Measured: 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%]
Measured: 3-12 months of orthodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tunnel attachments as an auxiliary with clear aligners
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyaa Aldohan, Harvard School of Dental Medicine
- Investigators
- Mohamed Masoud, BDS, DMSc, Principal investigator, Harvard School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130477
- Sponsor's protocol ID
- HarvardSDM
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30264270
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04130477
- Acronym / sponsor ID
- HarvardSDM
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Harvard School of Dental MedicineUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Tunnel attachments as an auxiliary with clear aligners
| Arm | Type | Receives |
|---|---|---|
| Clear aligners with tunnel attachment | Experimental | Device: Tunnel attachments and light Nickel Titanium wireParticipants 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 |
| Clear aligners | Active comparator | Device: Clear Aligner therapyParticipants will receive traditional clear aligner therapy with virtual set up |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tunnel attachments and light Nickel Titanium wireTunnel attachments planned virtually and light Nickel Titanium wire | Device | Clear aligners with tunnel attachment |
| Clear Aligner therapyClear Aligner therapy | Device | Clear aligners |
Primary outcome
1) Horizontal movement in millimeters
Time frame: 3-12 months of orthodontic treatment
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
Time frame: 3-12 months of orthodontic treatment
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
Time frame: 3-12 months of orthodontic treatment
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%]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Results publication: PubMed 30264270Papadimitriou 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Masoud, BDS, DMSc principal investigator
Harvard School of Dental Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Tunnel attachments and light Nickel Titanium wire and Clear Aligner therapy in people with Malocclusion, run by Harvard School of Dental Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alyaa Aldohan, BDS (8572658533, alyaa_aldohan@hsdm.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Horizontal movement in millimeters (time frame: 3-12 months of orthodontic treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.