MalocclusionNCT01771692
A Randomised Clinical Trial: Conventional Ligation vs Figure of 8
A study testing Extraction and Non extraction in people with Malocclusion, run by Rachel Little at 1 site in United Kingdom.
Trial summary
Fixed braces (appliances) are used to straighten the malalignment of teeth. There has been a lot of research into the factors that can affect the speed of alignment of teeth but there has been very little research on how different techniques of wire attachment to the brace (ligation) can affect this. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Extraction and Non extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to May 2016
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients at Burton Hospital
- 12-15 years of age at the start of treatment
- No medical contraindications
- Permanent dentition
- Mandibular incisor irregularity of 5-10mm (using Little's irregularity index)
- No other therapeutic intervention e.g. elastics, coils
- Informed consent gained
Who cannot join
- Presence of a craniofacial syndrome
- Patients already participating in a research study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's Hospital, Burton Hospitals NHS Foundation Trust
Burton-on-Trent, Staffordshire, DE13 0RB
About this study
Official title: A Study Into the Effects of Different Ligation Techniques on Orthodontic Mandibular Incisor Alignment
Fixed braces (appliances) are used to straighten the malalignment of teeth. There has been a lot of research into the factors that can affect the speed of alignment of teeth but there has been very little research on how different techniques of wire attachment to the brace (ligation) can affect this.
The randomised clinical trial of 100 patients aims to compare the speed of alignment of the lower (mandibular) front teeth (incisors) using two different techniques over a period of 12 weeks. Both techniques use the conventional small elastic rings (modules) that are placed over each metal square (bracket) but they will be tied in a different configuration for each group. We will also observe any differences in the distances between the corresponding teeth either side of the lower jaw for each group and the bracket failure rates.
Read the detailed description
The research protocol has been devised by Rachel Little (Specialty Registrar in Orthodontics), under the supervision of Mr David Spary (Consultant in Orthodontics) and Dr Ashish Dhopatkar (Head of Orthodontics, Birmingham Dental School).
Purpose:
In this study I intend to find out whether friction plays a part in lower incisor alignment by comparing different ligation techniques. If I can show that the speed of alignment is affected by different techniques, this will be an important finding for orthodontic treatment.
Aims:
This study aims to determine whether increased friction caused by ligation with figure of eight modules effects the speed of lower incisor alignment.
Recruitment and consent:
100 orthodontic patients (n=50 per group) who have attended a new patient clinic at Burton Hospital and who require correction for the malalignment of their teeth with a fixed appliances will be selected. Potential participants will be invited to take part in the study and will be given verbal and written information. If they agree to participate, written consent will be obtained. All patients will be competent and capable of making the decision. All patients in this study will be under 16 years of age, and so parental/legal guardian consent will be obtained. The patients will be able to withdraw from the study at any time, should they not wish to continue participating.
Method:
Participants will be randomly allocated to either the conventional module group (figure of O) or the figure of 8 module group, following consent for participation in the trial. Randomisation will use the method of block randomisation. Allocation will be undertaken by a non-clinician.
The plan is to use the study models (replica of the patient's teeth made out of plaster) from the pre treatment records as the baseline data then take an additional mould (impression) of the lower teeth only at each of the participants normal orthodontic appointments at six and twelve weeks after the appliances have been put on.
All measurements required will be taken from these study models using digital callipers, after the impressions have been cast in the laboratory.
Benefits of treatment:
- Improved appearance and function of the teeth
Risks of treatment:
- Tooth decay and gum disease (this can be prevented with good oral hygiene and low sugar intake)
- Discomfort
- Breakages
- Relapse (if retainers are not worn after the fixed appliances are removed)
- Root shortening
Confidentiality:
The study models that will be analysed will be stored in the patient's model box along with their notes in a locked office.
At no point during this research will personal details be disclosed to any persons not directly involved with providing orthodontic care.
Conflict of interest:
No conflict of interest is known or expected to arise during this study.
At the end of the study:
A summary sheet of the findings of this study will be made available to participants on request.
- Conditions
- Malocclusion
- Being tested
- Extraction, Non extraction
- Keywords
- Orthodontics
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExtractionOther
Extraction of teeth in the lower arch as part of the orthodontic treatment plan
Non extractionOther
Non extraction in the lower arch as part of the orthodontic treatment plan
| Study group | Role | What they receive |
|---|---|---|
| Conventional ligation | Active comparator | Modules ligated in a conventional manner (figure of 0) Receives: Other: Extraction; Other: Non extraction |
| Figure of 8 ligation | Active comparator | Modules ligated in a figure of 8 configuration Receives: Other: Extraction; Other: Non extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Little's irregularity index.
Mandibular incisor irregularity index reduction using Little's irregularity index.
Measured: up to12 weeks
Secondary outcomes (1)
Intercanine width.
Changes in intercanine widths between the two groups.
Measured: 0, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachel Little
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rachel Little, University of Birmingham
- Investigators
- David J Spary, BDS LDS FDS DOrth FDS Orth, Study director, Burton Hospitals Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771692
- Sponsor's protocol ID
- LIT001
- Status last verified
- Oct 2016
- First submitted
- 16 Jan 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Into the Effects of Different Ligation Techniques on Orthodontic Mandibular Incisor Alignment
- ClinicalTrials.gov ID
- NCT01771692
- Acronym / sponsor ID
- LIT001
- Conditions
- Malocclusion
- Keywords
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rachel LittleUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Jan 2013 (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.
Fixed braces (appliances) are used to straighten the malalignment of teeth. There has been a lot of research into the factors that can affect the speed of alignment of teeth but there has been very little research on how different techniques of wire attachment to the brace (ligation) can affect this.
The randomised clinical trial of 100 patients aims to compare the speed of alignment of the lower (mandibular) front teeth (incisors) using two different techniques over a period of 12 weeks. Both techniques use the conventional small elastic rings (modules) that are placed over each metal square (bracket) but they will be tied in a different configuration for each group. We will also observe any differences in the distances between the corresponding teeth either side of the lower jaw for each group and the bracket failure rates.
Detailed description
The research protocol has been devised by Rachel Little (Specialty Registrar in Orthodontics), under the supervision of Mr David Spary (Consultant in Orthodontics) and Dr Ashish Dhopatkar (Head of Orthodontics, Birmingham Dental School).
Purpose:
In this study I intend to find out whether friction plays a part in lower incisor alignment by comparing different ligation techniques. If I can show that the speed of alignment is affected by different techniques, this will be an important finding for orthodontic treatment.
Aims:
This study aims to determine whether increased friction caused by ligation with figure of eight modules effects the speed of lower incisor alignment.
Recruitment and consent:
100 orthodontic patients (n=50 per group) who have attended a new patient clinic at Burton Hospital and who require correction for the malalignment of their teeth with a fixed appliances will be selected. Potential participants will be invited to take part in the study and will be given verbal and written information. If they agree to participate, written consent will be obtained. All patients will be competent and capable of making the decision. All patients in this study will be under 16 years of age, and so parental/legal guardian consent will be obtained. The patients will be able to withdraw from the study at any time, should they not wish to continue participating.
Method:
Participants will be randomly allocated to either the conventional module group (figure of O) or the figure of 8 module group, following consent for participation in the trial. Randomisation will use the method of block randomisation. Allocation will be undertaken by a non-clinician.
The plan is to use the study models (replica of the patient's teeth made out of plaster) from the pre treatment records as the baseline data then take an additional mould (impression) of the lower teeth only at each of the participants normal orthodontic appointments at six and twelve weeks after the appliances have been put on.
All measurements required will be taken from these study models using digital callipers, after the impressions have been cast in the laboratory.
Benefits of treatment:
- Improved appearance and function of the teeth
Risks of treatment:
- Tooth decay and gum disease (this can be prevented with good oral hygiene and low sugar intake)
- Discomfort
- Breakages
- Relapse (if retainers are not worn after the fixed appliances are removed)
- Root shortening
Confidentiality:
The study models that will be analysed will be stored in the patient's model box along with their notes in a locked office.
At no point during this research will personal details be disclosed to any persons not directly involved with providing orthodontic care.
Conflict of interest:
No conflict of interest is known or expected to arise during this study.
At the end of the study:
A summary sheet of the findings of this study will be made available to participants on request.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ligation | Active comparator | Other: Extraction, Other: Non extractionModules ligated in a conventional manner (figure of 0) |
| Figure of 8 ligation | Active comparator | Other: Extraction, Other: Non extractionModules ligated in a figure of 8 configuration |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients at Burton Hospital
- 12-15 years of age at the start of treatment
- No medical contraindications
- Permanent dentition
- Mandibular incisor irregularity of 5-10mm (using Little's irregularity index)
Key exclusion criteria (2 listed)
- Presence of a craniofacial syndrome
- Patients already participating in a research study
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 |
|---|---|---|
| ExtractionExtraction of teeth in the lower arch as part of the orthodontic treatment plan | Other | Conventional ligation, Figure of 8 ligation |
| Non extractionNon extraction in the lower arch as part of the orthodontic treatment plan | Other | Conventional ligation, Figure of 8 ligation |
Primary outcome
Little's irregularity index.
Time frame: up to12 weeks
Mandibular incisor irregularity index reduction using Little's irregularity index.
1 secondary outcome
Intercanine width.
Time frame: 0, 6, 12 weeks
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 26 Oct 2016.
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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.
David J Spary, BDS LDS FDS DOrth FDS Orth study director
Burton Hospitals Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraction and Non extraction in people with Malocclusion, run by Rachel Little at 1 site 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 2 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 26 Oct 2016. 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 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. 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?
Little's irregularity index. (time frame: up to12 weeks). 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 26 Oct 2016.