Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
96 participants
INTERVENTIONAL
2009-08-31
2013-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
InOvation C
Active Self-ligating Bracket
Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
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.
Ovation
Conventional Bracket
Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
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.
Damon Q
Self-ligating bracket
Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
East Kent Hospitals University NHS Foundation Trust
OTHER_GOV
Southend NHS Foundation Trust
OTHER
Barts & The London NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert t Lee, MDS
Role: PRINCIPAL_INVESTIGATOR
Royal London Dental Institute
Ama Johal, PhD
Role: STUDY_DIRECTOR
QMUL
Valeria Marinho, PhD
Role: STUDY_DIRECTOR
QMUL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
East Kent Hospitals NHS Foundation Trust
Canterbury, Kent, United Kingdom
Royal London Dental Institute
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2
Identifier Type: -
Identifier Source: org_study_id