Bimaxillary ProclinationNCT04001816
A Randomized Clinical Trial to Investigate Whether Self Ligating Brackets or Conventional Brackets Are Better for Treating Bimaxillary Proclination
A study testing Orthodontic Brackets in people with Bimaxillary Proclination, run by The University of The West Indies at 1 site in Trinidad and Tobago.
Trial summary
The study is a single blind randomised control trial.The patients will be randomly assigned to have conventional brackets placed or self ligating brackets placed. All patients will undergo full Orthodontic records. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Bimaxillary Proclination
- What is being tested?
- Orthodontic Brackets
- How many people
- 100 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- 4 Jan 2017to 30 Jun 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Bimaxillary Proclination
- Class I or Class II division 1 incisor relationship with an overjet less than or equal to 6.0 mm
- The cases can be extraction or non extraction cases
- Extraction cases must be of at least both upper first premolars to relieve moderate to severe crowding and/or to reduce the overjet
- No previous orthodontic treatment
- No systemic illness
Show all 11Show fewer
- No use of anti inflammatory drugs prior to placement of the fixed appliance
- Good oral hygiene and periodontal health with periodontal pockets of less than or equal to 4 mm, full-mouth plaque score less than or equal to 20 per cent
- Cooperative and motivated
- In the permanent dentition with all teeth present at least to the first molars
- No radiographic bone loss was observed on the dental pantomographic image.
Who cannot join
- Patients who required surgery to correct skeletal discrepancies.
- Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site, 1 recruiting
- Recruiting
UWI Dental School
Saint Augustine
Trudee Hoyte, 8686845008, Trudee.Hoyte@sta.uwi.edu
About this study
The study is a single blind randomised control trial.The patients will be randomly assigned to have conventional brackets placed or self ligating brackets placed.
All patients will undergo full Orthodontic records. This will include an Orthodontic assesment, study models relevant xrays (orthopantogram and a cephalomgram) and clinical photos. After records analysis, patients will be given a prophylaxis and oral hygiene instructions.
Read more
Either 3m Victory Series™ Metal Braces or 3m SmartClip™ SL3 Self-Ligating Braces both bracket types will carry the MBT prescription 0.022 slot height, will be bonded using Transbond™ XT (3M Unitek, Monrovia, California, USA) composite resin according to the manufactuer's instruction.
These patients will be recalled at monthly intervals for the duration of treatment time which will be 3 years. A cephalogram will be taken at the end of treatment
- Conditions
- Bimaxillary Proclination
- Being tested
- Orthodontic Brackets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic BracketsOther
Self ligating and Conventional brackets
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment time
Length of time each bracket takes to treat a bimaxillary proclination patient
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start4 Jan 2017
- Primary completion31 May 2021 (estimated)
- Study completion30 Jun 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 Bimaxillary ProclinationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dundee
- Responsible party
- Principal investigator, Trudee Hoyte, The University of The West Indies
- Investigators
- Trudee Hoyte, Principal investigator, The University of The West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001816
- Sponsor's protocol ID
- UWestIndiesSt.Augustine
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoyte T, Ali A, James A, Bearn D. Effectiveness of self-ligating versus conventional brackets for treatment of bimaxillary protrusion: a single-centre randomized clinical trial. Eur J Orthod. 2026 Feb 18;48(2):cjag013. doi: 10.1093/ejo/cjag013.
PubMed 41805224
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Investigate Whether Self Ligating Brackets or Conventional Brackets Are Better for Treating Bimaxillary Proclination
- ClinicalTrials.gov ID
- NCT04001816
- Acronym / sponsor ID
- UWestIndiesSt.Augustine
- Conditions
- Bimaxillary Proclination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Collaborators
- University of Dundee
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 28 Jun 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.
The study is a single blind randomised control trial.The patients will be randomly assigned to have conventional brackets placed or self ligating brackets placed.
All patients will undergo full Orthodontic records. This will include an Orthodontic assesment, study models relevant xrays (orthopantogram and a cephalomgram) and clinical photos. After records analysis, patients will be given a prophylaxis and oral hygiene instructions.
Either 3m Victory Series™ Metal Braces or 3m SmartClip™ SL3 Self-Ligating Braces both bracket types will carry the MBT prescription 0.022 slot height, will be bonded using Transbond™ XT (3M Unitek, Monrovia, California, USA) composite resin according to the manufactuer's instruction.
These patients will be recalled at monthly intervals for the duration of treatment time which will be 3 years. A cephalogram will be taken at the end of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Bimaxillary Proclination
- Class I or Class II division 1 incisor relationship with an overjet less than or equal to 6.0 mm
- The cases can be extraction or non extraction cases
- Extraction cases must be of at least both upper first premolars to relieve moderate to severe crowding and/or to reduce the overjet
- No previous orthodontic treatment
Key exclusion criteria (3 listed)
- Patients who required surgery to correct skeletal discrepancies.
- Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
- Uncooperative patients
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 |
|---|---|---|
| Orthodontic BracketsSelf ligating and Conventional brackets | Other | – |
Primary outcome
Treatment time
Time frame: 18-24 months
Length of time each bracket takes to treat a bimaxillary proclination patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Derived from this study: PubMed 41805224Hoyte T, Ali A, James A, Bearn D. Effectiveness of self-ligating versus conventional brackets for treatment of bimaxillary protrusion: a single-centre randomized clinical trial. Eur J Orthod. 2026 Feb 18;48(2):cjag013. doi: 10.1093/ejo/cjag013.
- Individual participant dataSharing planned: No
Related trials for Bimaxillary Proclination
Not yet recruiting
Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques
Bimaxillary Proclination, Bimaxillary Protrusion
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.
Trudee Hoyte principal investigator
The University of The West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic Brackets in people with Bimaxillary Proclination, run by The University of The West Indies at 1 site in Trinidad and Tobago.
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 11 inclusion and 3 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 28 Jun 2019. 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 Trinidad and Tobago. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trudee Hoyte (8686845008, Trudee.Hoyte@sta.uwi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment time (time frame: 18-24 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 NCT04001816, 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 28 Jun 2019.