Irregular TeethNCT04357067
Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase
A study testing Lingual brackets and Labial brackets in people with Irregular Teeth, run by Aydin Adnan Menderes University.
Trial summary
This aim study aims to compare clinical effectiveness of customized lingual brackets and conventional labial brackets in alignment period in a sample of Class I malocclusion patients treated on a nonextraction basis. Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- Irregular Teeth
- What is being tested?
- Lingual brackets and Labial brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 Apr 2017
- 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 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Class I malocclusion
- Completed permanent dentition
- Crowding ≥ 6 mm
Who cannot join
- Tooth loss or extraction except third molars
- Having cross bite
- Having genetic or hormonal disorder
- Using a chronic drug
- Previous orthodontic treatment and prosthetic restoration
- Inappropriate oral hygiene and periodontal diseases
About this study
This aim study aims to compare clinical effectiveness of customized lingual brackets and conventional labial brackets in alignment period in a sample of Class I malocclusion patients treated on a nonextraction basis.
Read the detailed description
The study included 20 patients who presented with Class I malocclusion and scheduled for orthodontic treatment without tooth extraction. The patients were randomly assigned for treatment with customized lingual brackets or with conventional labial brackets. During the alignment period 0.012 inch (T1) , 0.014 inch(T2), 0.016 inch (T3)NiTi arch wires were performed respectively and the control visits were scheduled by 6-weeks intervals. In all sessions, digital models were obtained by intra-oral scanning device after removal of arch wire, which then analyzed by software. In order to analyze change in T0 (pretreatment), T1, T2 and T3; Little's irregularity index, distance between canine teeth, distance between first premolar teeth, distance between second premolar teeth, distance between first molar teeth and arch length measurements were performed on digital models.
- Conditions
- Irregular Teeth
- Being tested
- Lingual brackets, Labial brackets
- Keywords
- Customized lingual brackets, lingual orthodontics, digital model
- Medical subject headings
- Tooth Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual bracketsDevice
Also called Customized lingual brackets
A type of bracket that applied lingual surface of teeth.
Labial bracketsDevice
Also called Conventional labial brackets
A type of bracket that applied labial surface of teeth.
| Study group | Role | What they receive |
|---|---|---|
| Lingual brackets | Experimental | Patients with moderate crowding without extraction treated with Incognito lingual bracket (3M Unitek, Bad Essen, Germany) Receives: Device: Lingual brackets; Device: Labial brackets |
| Labial brackets | Experimental | Patients with moderate crowding without extraction treated with labial bracket (3M Unitek, Ca, USA Receives: Device: Lingual brackets; Device: Labial brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irregularity index (mm)
Crowding of anterior teeth changes after alignment
Measured: 18 weeks
Distance between canine teeth (mm)
Measurement from right canine to left canine distance
Measured: 18 weeks
Distance between first premolar teeth (mm)
Measurement from right first premolar to left first premolar distance
Measured: 18 weeks
Distance between second premolar teeth (mm)
Measurement from right first premolar to left first premolar distance
Measured: 18 weeks
Distance between first molar teeth (mm)
Measurement from right first molar to left first molar distance
Measured: 18 weeks
Secondary outcomes (1)
Arch length (mm)
Measurement of arch length from mesial side of right first molar to messiah side of left first molar
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Oct 2015
- Primary completion5 Jan 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Irregular TeethStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YAZGI AY UNUVAR, PhD, Aydin Adnan Menderes University
- Investigators
- Yazgı Ay Ünüvar, PhD, Study director, Aydın Adnan Menderes University Faculty of Dentistry Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357067
- Sponsor's protocol ID
- DHF-15010
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khattab TZ, Hajeer MY, Farah H, Al-Sabbagh R. Maxillary dental arch changes following the leveling and alignment stage with lingual and labial orthodontic appliances: a preliminary report of a randomized controlled trial. J Contemp Dent Pract. 2014 Sep 1;15(5):561-6. doi: 10.5005/jp-journals-10024-1579.
PubMed 25707826Auluck A. Lingual orthodontic treatment: what is the current evidence base? J Orthod. 2013 Sep;40 Suppl 1:S27-33. doi: 10.1179/1465313313Y.0000000073.
PubMed 24005948Alobeid A, El-Bialy T, Reimann S, Keilig L, Cornelius D, Jager A, Bourauel C. Comparison of the efficacy of tooth alignment among lingual and labial brackets: an in vitro study. Eur J Orthod. 2018 Nov 30;40(6):660-665. doi: 10.1093/ejo/cjy005.
PubMed 29546390Ziebura T, Hohoff A, Flieger S, Stamm T. Accidental debondings: Buccal vs fully individualized lingual multibracket appliances. Am J Orthod Dentofacial Orthop. 2014 May;145(5):649-54. doi: 10.1016/j.ajodo.2013.12.030.
PubMed 24785929Sifakakis I, Pandis N, Makou M, Eliades T, Katsaros C, Bourauel C. A comparative assessment of torque generated by lingual and conventional brackets. Eur J Orthod. 2013 Jun;35(3):375-80. doi: 10.1093/ejo/cjs029. Epub 2012 May 9.
PubMed 22573909Sifakakis I, Pandis N, Makou M, Katsaros C, Eliades T, Bourauel C. A comparative assessment of forces and moments generated by lingual and conventional brackets. Eur J Orthod. 2013 Feb;35(1):82-6. doi: 10.1093/ejo/cjr048. Epub 2011 Apr 4.
PubMed 21464153Fuck LM, Wiechmann D, Drescher D. Comparison of the initial orthodontic force systems produced by a new lingual bracket system and a straight-wire appliance. J Orofac Orthop. 2005 Sep;66(5):363-76. doi: 10.1007/s00056-005-0442-3. English, German.
PubMed 16231112
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase
- ClinicalTrials.gov ID
- NCT04357067
- Acronym / sponsor ID
- DHF-15010
- Conditions
- Irregular Teeth
- Keywords
- Customized lingual brackets, lingual orthodontics, digital model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 22 Apr 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.
This aim study aims to compare clinical effectiveness of customized lingual brackets and conventional labial brackets in alignment period in a sample of Class I malocclusion patients treated on a nonextraction basis.
Detailed description
The study included 20 patients who presented with Class I malocclusion and scheduled for orthodontic treatment without tooth extraction. The patients were randomly assigned for treatment with customized lingual brackets or with conventional labial brackets. During the alignment period 0.012 inch (T1) , 0.014 inch(T2), 0.016 inch (T3)NiTi arch wires were performed respectively and the control visits were scheduled by 6-weeks intervals. In all sessions, digital models were obtained by intra-oral scanning device after removal of arch wire, which then analyzed by software. In order to analyze change in T0 (pretreatment), T1, T2 and T3; Little's irregularity index, distance between canine teeth, distance between first premolar teeth, distance between second premolar teeth, distance between first molar teeth and arch length measurements were performed on digital models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lingual brackets | Experimental | Device: Lingual brackets, Device: Labial bracketsPatients with moderate crowding without extraction treated with Incognito lingual bracket (3M Unitek, Bad Essen, Germany) |
| Labial brackets | Experimental | Device: Lingual brackets, Device: Labial bracketsPatients with moderate crowding without extraction treated with labial bracket (3M Unitek, Ca, USA |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Class I malocclusion
- Completed permanent dentition
- Crowding ≥ 6 mm
Key exclusion criteria (6 listed)
- Tooth loss or extraction except third molars
- Having cross bite
- Having genetic or hormonal disorder
- Using a chronic drug
- Previous orthodontic treatment and prosthetic restoration
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 |
|---|---|---|
| Lingual bracketsAlso: Customized lingual bracketsA type of bracket that applied lingual surface of teeth. | Device | Labial brackets, Lingual brackets |
| Labial bracketsAlso: Conventional labial bracketsA type of bracket that applied labial surface of teeth. | Device | Labial brackets, Lingual brackets |
Primary outcome
Irregularity index (mm)
Time frame: 18 weeks
Crowding of anterior teeth changes after alignment
Distance between canine teeth (mm)
Time frame: 18 weeks
Measurement from right canine to left canine distance
Distance between first premolar teeth (mm)
Time frame: 18 weeks
Measurement from right first premolar to left first premolar distance
Distance between second premolar teeth (mm)
Time frame: 18 weeks
Measurement from right first premolar to left first premolar distance
Distance between first molar teeth (mm)
Time frame: 18 weeks
Measurement from right first molar to left first molar distance
1 secondary outcome
Arch length (mm)
Time frame: 18 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 22 Apr 2020.
- Background: PubMed 25707826Khattab TZ, Hajeer MY, Farah H, Al-Sabbagh R. Maxillary dental arch changes following the leveling and alignment stage with lingual and labial orthodontic appliances: a preliminary report of a randomized controlled trial. J Contemp Dent Pract. 2014 Sep 1;15(5):561-6. doi: 10.5005/jp-journals-10024-1579.
- Background: PubMed 24005948Auluck A. Lingual orthodontic treatment: what is the current evidence base? J Orthod. 2013 Sep;40 Suppl 1:S27-33. doi: 10.1179/1465313313Y.0000000073.
- Background: PubMed 29546390Alobeid A, El-Bialy T, Reimann S, Keilig L, Cornelius D, Jager A, Bourauel C. Comparison of the efficacy of tooth alignment among lingual and labial brackets: an in vitro study. Eur J Orthod. 2018 Nov 30;40(6):660-665. doi: 10.1093/ejo/cjy005.
- Background: PubMed 24785929Ziebura T, Hohoff A, Flieger S, Stamm T. Accidental debondings: Buccal vs fully individualized lingual multibracket appliances. Am J Orthod Dentofacial Orthop. 2014 May;145(5):649-54. doi: 10.1016/j.ajodo.2013.12.030.
- Background: PubMed 22573909Sifakakis I, Pandis N, Makou M, Eliades T, Katsaros C, Bourauel C. A comparative assessment of torque generated by lingual and conventional brackets. Eur J Orthod. 2013 Jun;35(3):375-80. doi: 10.1093/ejo/cjs029. Epub 2012 May 9.
- Background: PubMed 21464153Sifakakis I, Pandis N, Makou M, Katsaros C, Eliades T, Bourauel C. A comparative assessment of forces and moments generated by lingual and conventional brackets. Eur J Orthod. 2013 Feb;35(1):82-6. doi: 10.1093/ejo/cjr048. Epub 2011 Apr 4.
- Background: PubMed 16231112Fuck LM, Wiechmann D, Drescher D. Comparison of the initial orthodontic force systems produced by a new lingual bracket system and a straight-wire appliance. J Orofac Orthop. 2005 Sep;66(5):363-76. doi: 10.1007/s00056-005-0442-3. English, German.
- Individual participant dataSharing planned: No
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.
Yazgı Ay Ünüvar, PhD study director
Aydın Adnan Menderes University Faculty of Dentistry Department of Orthodontics
Questions about this trial
What is this clinical trial studying?
A study testing Lingual brackets and Labial brackets in people with Irregular Teeth, run by Aydin Adnan Menderes University.
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 3 inclusion and 6 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Irregularity index (mm) (time frame: 18 weeks). The study lists 5 primary outcomes in all. 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 NCT04357067, which also lists 7 linked publications.
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 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.