Orthodontic TreatmentNCT01320657
A Clinical Trial of Three Fixed Orthodontic Appliances
A study testing Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket in people with Orthodontic Treatment, run by Barts & The London NHS Trust at 2 sites in United Kingdom.
Trial summary
This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Treatment
- What is being tested?
- Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2009to May 2013
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Young adults aged 16 years and over;
- Fit and well and on no medication;
- In the permanent dentition;
- Undergoing orthodontic treatment in preparation for combined orthodontic-surgical care
- or
- Subjects considered suitable for non-extraction maxillary arch treatment if not undergoing combined orthodontic-surgical treatment;
- Crowding less than 6mm
Who cannot join
- Cleft lip and palate and other craniofacial anomalies.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
East Kent Hospitals NHS Foundation Trust
Canterbury, Kent, CT1 3NG
Royal London Dental Institute
London, E1 1BB
About this study
Official title: A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models
This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.
The effects of three different types of train-track will be assessed with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.
Read the detailed description
This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.
The effects of three different types of train-track will be assessed in this clinical trial with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.
- Conditions
- Orthodontic Treatment
- Being tested
- Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
- Keywords
- Self-ligating, orthodontic, appliance, expansion, dental inclination, Expansion and inclination changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracketDevice
Subjects randomized to treatment with one of three fixed orthodontic appliances: Damon Q, InOvation C and Ovation brackets. A pre-determined archwire sequence will be used involving round nickel titanium, rectangular nickel titanium progressing to 0.019 X 0.025 inch stainless steel; specific archwire sequences and appointment intervals will be based on the manufacturer's guidelines. All erupted teeth will have attachments placed from the outset.
Treated for a minimum of 8 months with the 0.019 X 0.025 inch stainless steel archwire in place for at least 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| InOvation C | Active comparator | Active Self-ligating Bracket Receives: Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket |
| Ovation | Placebo comparator | Conventional Bracket Receives: Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket |
| Damon Q | Experimental | Self-ligating bracket Receives: Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transverse dimensional changes and bucco-lingual inclination changes
Width in mm
Measured: 3 years 10 months
Secondary outcomes (1)
Subjective pain experience
Pain score
Measured: 3 years 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startAug 2009
- Primary completionAug 2012
- Study completionMay 2013
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 Orthodontic TreatmentStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- East Kent Hospitals University NHS Foundation Trust, Southend NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Robert t Lee, MDS, Principal investigator, Royal London Dental InstituteAma Johal, PhD, Study director, QMULValeria Marinho, PhD, Study director, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320657
- Sponsor's protocol ID
- 2
- Status last verified
- Apr 2012
- First submitted
- 21 Mar 2011
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fleming PS, Lee RT, Marinho V, Johal A. Comparison of maxillary arch dimensional changes with passive and active self-ligation and conventional brackets in the permanent dentition: a multicenter, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):185-93. doi: 10.1016/j.ajodo.2013.03.012.
PubMed 23910199
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models
- ClinicalTrials.gov ID
- NCT01320657
- Acronym / sponsor ID
- 2
- Conditions
- Orthodontic Treatment
- Keywords
- Self-ligating, orthodontic, appliance, expansion, dental inclination, Expansion and inclination changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- East Kent Hospitals University NHS Foundation Trust, Southend NHS Foundation Trust
- Study start
- Aug 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Mar 2011 (estimated)
- 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.
This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.
The effects of three different types of train-track will be assessed with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.
Detailed description
This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.
The effects of three different types of train-track will be assessed in this clinical trial with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| InOvation C | Active comparator | Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracketActive Self-ligating Bracket |
| Ovation | Placebo comparator | Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracketConventional Bracket |
| Damon Q | Experimental | Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracketSelf-ligating bracket |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Young adults aged 16 years and over;
- Fit and well and on no medication;
- In the permanent dentition;
- Undergoing orthodontic treatment in preparation for combined orthodontic-surgical care
- or
Key exclusion criteria (1 listed)
- Cleft lip and palate and other craniofacial anomalies.
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 |
|---|---|---|
| Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracketSubjects randomized to treatment with one of three fixed orthodontic appliances: Damon Q, InOvation C and Ovation brackets. A pre-determined archwire sequence will be used involving round nickel titanium, rectangular nickel titanium progressing to 0.019 X 0.025 inch stainless steel; specific archwire sequences and appointment intervals will be based on the manufacturer's guidelines. All erupted teeth will have attachments placed from the outset. Treated for a minimum of 8 months with the 0.019 X 0.025 inch stainless steel archwire in place for at least 8 weeks. | Device | Damon Q, InOvation C, Ovation |
Primary outcome
Transverse dimensional changes and bucco-lingual inclination changes
Time frame: 3 years 10 months
Width in mm
1 secondary outcome
Subjective pain experience
Time frame: 3 years 10 months
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 22 Dec 2022.
- Derived from this study: PubMed 23910199Fleming PS, Lee RT, Marinho V, Johal A. Comparison of maxillary arch dimensional changes with passive and active self-ligation and conventional brackets in the permanent dentition: a multicenter, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):185-93. doi: 10.1016/j.ajodo.2013.03.012.
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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.
Robert t Lee, MDS principal investigator
Royal London Dental Institute
Ama Johal, PhD study director
QMUL
Valeria Marinho, PhD study director
QMUL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket in people with Orthodontic Treatment, run by Barts & The London NHS Trust at 2 sites in United Kingdom.
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 7 inclusion and 1 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Transverse dimensional changes and bucco-lingual inclination changes (time frame: 3 years 10 months). 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 NCT01320657, 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 22 Dec 2022.