Malocclusion, Angle Class IINCT04556448
RCT Comparing Invisalign and Traditional Orthodontic Treatment
A study testing Aligners and Clear braces in people with Malocclusion, Angle Class II, run by Texas A&M University at 1 site in United States.
Trial summary
Comparison of orthodontic patients treated with aligners and traditional (clear braces) Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- Aligners and Clear braces
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 1 Mar 2019
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Class I molar and canine relationships
- Non-extraction treatments
- Mandibular crowding of 4 mm or less
- No missing tooth (from second to second molar)
Who cannot join
- Anterior or posterior crossbites
- Anterior or lateral open bites
- Maxillary overjet exceeding 3mm
- Impacted tooth
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M Baylor College of Dentisry
Dallas, Texas, 75246
About this study
Official title: A Randomized Controlled Trial Comparing the Effectiveness of Invisalign and Traditional Orthodontic Treatments
Comparison of orthodontic patients treated with aligners and traditional (clear braces)
Read the detailed description
Patients were selected based on being adults and having mild Class I malocclusion. They were randomly allocated into either the aligner group and the traditiona (clear braces group).. The aligner group was treated with invisalign, with up to two adjustments at the end of treatment. The traditional group had clear braces placed on their teeth. The outcome variables including the following: 1) pain and discomfort related to treatment, 2) posttreatment occlusal status, and 3) postretention occlusal status.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Aligners, Clear braces
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlignersOther
Also called Invisalign
Clear aligners
Clear bracesOther
Clear braces
| Study group | Role | What they receive |
|---|---|---|
| Aligners | Experimental | Invisalign treatment Receives: Other: Aligners |
| Traditional braces | Active comparator | Clear braces Receives: Other: Clear braces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal changes
Differences in occlusion between the two groups
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Jan 2013
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Randomized RCT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter H. Buschang, Texas A&M University
- Investigators
- Peter Buschang, PhD, Principal investigator, TAMU Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556448
- Sponsor's protocol ID
- 2012-21_COD_Ortho1
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effectiveness of Invisalign and Traditional Orthodontic Treatments
- ClinicalTrials.gov ID
- NCT04556448
- Acronym / sponsor ID
- 2012-21_COD_Ortho1
- Conditions
- Malocclusion, Angle Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 21 Sep 2020 (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.
Comparison of orthodontic patients treated with aligners and traditional (clear braces)
Detailed description
Patients were selected based on being adults and having mild Class I malocclusion. They were randomly allocated into either the aligner group and the traditiona (clear braces group).. The aligner group was treated with invisalign, with up to two adjustments at the end of treatment. The traditional group had clear braces placed on their teeth. The outcome variables including the following: 1) pain and discomfort related to treatment, 2) posttreatment occlusal status, and 3) postretention occlusal status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized RCT
| Arm | Type | Receives |
|---|---|---|
| Aligners | Experimental | Other: AlignersInvisalign treatment |
| Traditional braces | Active comparator | Other: Clear bracesClear braces |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Class I molar and canine relationships
- Non-extraction treatments
- Mandibular crowding of 4 mm or less
- No missing tooth (from second to second molar)
Key exclusion criteria (4 listed)
- Anterior or posterior crossbites
- Anterior or lateral open bites
- Maxillary overjet exceeding 3mm
- Impacted tooth
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 |
|---|---|---|
| AlignersAlso: InvisalignClear aligners | Other | Aligners |
| Clear bracesClear braces | Other | Traditional braces |
Primary outcome
Occlusal changes
Time frame: up to 6 months
Differences in occlusion between the two groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
Related trials for Malocclusion, Angle Class II
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Malocclusion, Angle Class II
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.
Peter Buschang, PhD principal investigator
TAMU Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aligners and Clear braces in people with Malocclusion, Angle Class II, run by Texas A&M University at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusal changes (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2020.