Malocclusion of Anterior TeethNCT03647241

Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion

A study testing Self-Ligating Brackets, Traditionally-Ligated Brackets and Corticotomy in people with Malocclusion of Anterior Teeth, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be admitted then the initial diagnostic records (diagnostic gypsum samples - internal and external oral photographs as well as radiographic images) will be studied to ensure… Read more about this study

Who is it for?: Ages 17 to 28 years
Conditions the study is for: Malocclusion of Anterior Teeth
What is being tested?: Self-Ligating Brackets, Traditionally-Ligated Brackets and Corticotomy
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSyria
Study dates: 15 Aug 2018to 19 Jun 2020
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 17 to 28 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age of patients: 17-28 years.
Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
The Little's Index of Irregularity is over 7 mm.
There is no previous orthodontic treatment.
The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).
The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963).

Show all 10Show fewer

Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship.
Overbite is between 0-4 mm.
There is no skeletal constriction on the upper jaw.
Full presence of all permanent teeth in the dental arch (except for third molars)

Who cannot join

Any systemic diseases that would affect tooth movement .
Any congenital syndromes or cleft lip and palate cases
Bad oral health

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Orthodontics, University of Damascus Dental School
Damascus, DM20AM18

Other trials in Syria

About this study

Official title: An Evaluation of the Efficacy of Self-Ligating Brackets Alone Or In Combination With Flapless Corticotomy In Leveling And Aligning Severely Crowded Dental Arches Compared With Conventional Brackets: A Randomized Clinical Controlled Trial

The aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth:

Group 1 : Patients will be treated using self-ligating brackets
Group 2 : Patients will be treated using self-ligating brackets associated with flapless corticotomy.
Group 3 : Patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth)

At the end of leveling and aligning phase, we will compare the self-ligating brackets and traditional brackets ( the acceleration of teeth movement, dental and alveolar changes and other variables ) Also, there is an intention to study the effectiveness of using flapless corticotomy with the self-ligating brackets.

Read the detailed description

The sample of this study will be chosen according the following steps:

The examination of patients referred to the Department of Orthodontics at the University of Damascus Dental School (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial.
A random sample of 100 patients from the sampling frame will be chosen.
An information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. Then consent forms will be collected from those who agree to participate.
A random selection of 60 patients will be performed. Then a random distribution of these patients to 3 groups will be done.

Conditions: Malocclusion of Anterior Teeth
Being tested: Self-Ligating Brackets, Traditionally-Ligated Brackets, Corticotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self-Ligating BracketsDevice
Also called SLBs
These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.
Traditionally-Ligated BracketsDevice
Also called Non-SLBs
These brackets are used in the conventional manner, where the orthodontist is obliged to use elastic modules to engage the arch into the slot of the bracket.
CorticotomyProcedure or surgery
Also called Piezosurgery, Decortication
Corticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.

Study groups in NCT03647241
Study group	Role	What they receive
Self-Ligating Brackets	Experimental	Patients will be treated using self-ligating brackets to achieve proper alignment of teeth Receives: Device: Self-Ligating Brackets
Self-Ligating Brackets with Corticotomy	Experimental	Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment. Receives: Device: Self-Ligating Brackets; Procedure: Corticotomy
Traditionally-Ligated Brackets	Active comparator	Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth Receives: Device: Traditionally-Ligated Brackets

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Alignment
The time required in days will be calculated from the beginning of treatment till the end of the alignment stage
Measured: This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months)
Change in Little's Index
The irregularity of the upper and lower incisors is calculated by measuring the amount of deviation of the anatomic contact points between the six incisors in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). The more the score is, the more crowded the case is.
Measured: T0: one day before the beginning of treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months)
Change in inter-canine width lingually
The distance between the most lingual points on the lingual surface of the canines on the upper dental arch. This will be measured on plaster models.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Change in inter-canine width
The distance between the cusp tips of the upper canines. This variable will be measured on plaster models.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Change in Canine Rotation Angle
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the canine.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Change in Lateral Incisor Rotation Angle
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the lateral incisor.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Change in Central Incisor Rotation Angle
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the central incisor.
Measured: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201819 Jun 2020

First posted27 Aug 2018
Study start15 Aug 2018
Primary completion10 Nov 2019
Study completion19 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Malocclusion of Anterior TeethStudies 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03647241
Sponsor's protocol ID: UDDS-Ortho-10-2018
Status last verified: Nov 2020
First submitted: 22 Aug 2018
Last updated: 20 Nov 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yang X, Xue C, He Y, Zhao M, Luo M, Wang P, Bai D. Transversal changes, space closure, and efficiency of conventional and self-ligating appliances : A quantitative systematic review. J Orofac Orthop. 2018 Jan;79(1):1-10. doi: 10.1007/s00056-017-0110-4. Epub 2017 Nov 3.
PubMed 29101414
Yang X, Su N, Shi Z, Xiang Z, He Y, Han X, Bai D. Effects of self-ligating brackets on oral hygiene and discomfort: a systematic review and meta-analysis of randomized controlled clinical trials. Int J Dent Hyg. 2017 Feb;15(1):16-22. doi: 10.1111/idh.12220. Epub 2016 Apr 20.
PubMed 27095145
Yang X, He Y, Chen T, Zhao M, Yan Y, Wang H, Bai D. Differences between active and passive self-ligating brackets for orthodontic treatment : Systematic review and meta-analysis based on randomized clinical trials. J Orofac Orthop. 2017 Mar;78(2):121-128. doi: 10.1007/s00056-016-0059-8. Epub 2017 Feb 21.
PubMed 28224175
Qamruddin I, Alam MK, Mahroof V, Fida M, Khamis MF, Husein A. Effects of low-level laser irradiation on the rate of orthodontic tooth movement and associated pain with self-ligating brackets. Am J Orthod Dentofacial Orthop. 2017 Nov;152(5):622-630. doi: 10.1016/j.ajodo.2017.03.023.
PubMed 29103440
Nahas AZ, Samara SA, Rastegar-Lari TA. Decrowding of lower anterior segment with and without photobiomodulation: a single center, randomized clinical trial. Lasers Med Sci. 2017 Jan;32(1):129-135. doi: 10.1007/s10103-016-2094-5. Epub 2016 Oct 20.
PubMed 27761668
Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.
PubMed 27484605
Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
PubMed 27129491
Wahab RM, Idris H, Yacob H, Ariffin SH. Comparison of self- and conventional-ligating brackets in the alignment stage. Eur J Orthod. 2012 Apr;34(2):176-81. doi: 10.1093/ejo/cjq179. Epub 2011 Apr 8.
PubMed 21478298
Scott P, DiBiase AT, Sherriff M, Cobourne MT. Alignment efficiency of Damon3 self-ligating and conventional orthodontic bracket systems: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):470.e1-8. doi: 10.1016/j.ajodo.2008.04.018.
PubMed 18929262

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malocclusion of Anterior Teeth trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Efficacy of Self-Ligating Brackets Alone Or In Combination With Flapless Corticotomy In Leveling And Aligning Severely Crowded Dental Arches Compared With Conventional Brackets: A Randomized Clinical Controlled Trial
ClinicalTrials.gov ID: NCT03647241
Acronym / sponsor ID: UDDS-Ortho-10-2018
Conditions: Malocclusion of Anterior Teeth
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 15 Aug 2018 (actual)
Primary completion: 10 Nov 2019 (actual)
Study completion: 19 Jun 2020 (actual)
First posted: 27 Aug 2018 (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 aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth:

Group 1 : Patients will be treated using self-ligating brackets
Group 2 : Patients will be treated using self-ligating brackets associated with flapless corticotomy.
Group 3 : Patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth)

Detailed description

The sample of this study will be chosen according the following steps:

The examination of patients referred to the Department of Orthodontics at the University of Damascus Dental School (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial.
A random sample of 100 patients from the sampling frame will be chosen.
An information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. Then consent forms will be collected from those who agree to participate.
A random selection of 60 patients will be performed. Then a random distribution of these patients to 3 groups will be done.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Self-Ligating Brackets	Experimental	Device: Self-Ligating BracketsPatients will be treated using self-ligating brackets to achieve proper alignment of teeth
Self-Ligating Brackets with Corticotomy	Experimental	Device: Self-Ligating Brackets, Procedure: CorticotomyPatients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment.
Traditionally-Ligated Brackets	Active comparator	Device: Traditionally-Ligated BracketsPatients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth

Who may qualify

Ages: 17 to 28 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Age of patients: 17-28 years.
Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
The Little's Index of Irregularity is over 7 mm.
There is no previous orthodontic treatment.
The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).

Key exclusion criteria (3 listed)

Any systemic diseases that would affect tooth movement .
Any congenital syndromes or cleft lip and palate cases
Bad oral health

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
Self-Ligating BracketsAlso: SLBsThese brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.	Device	Self-Ligating Brackets, Self-Ligating Brackets with Corticotomy
Traditionally-Ligated BracketsAlso: Non-SLBsThese brackets are used in the conventional manner, where the orthodontist is obliged to use elastic modules to engage the arch into the slot of the bracket.	Device	Traditionally-Ligated Brackets
CorticotomyAlso: Piezosurgery, DecorticationCorticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.	Procedure or surgery	Self-Ligating Brackets with Corticotomy

Primary outcome

Duration of Alignment
Time frame: This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months)
The time required in days will be calculated from the beginning of treatment till the end of the alignment stage
Change in Little's Index
Time frame: T0: one day before the beginning of treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months)
The irregularity of the upper and lower incisors is calculated by measuring the amount of deviation of the anatomic contact points between the six incisors in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). The more the score is, the more crowded the case is.
Change in inter-canine width lingually
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
The distance between the most lingual points on the lingual surface of the canines on the upper dental arch. This will be measured on plaster models.
Change in inter-canine width
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
The distance between the cusp tips of the upper canines. This variable will be measured on plaster models.
Change in Canine Rotation Angle
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the canine.
Change in Lateral Incisor Rotation Angle
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the lateral incisor.
Change in Central Incisor Rotation Angle
Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the central incisor.

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 20 Nov 2020.
Background: PubMed 29101414Yang X, Xue C, He Y, Zhao M, Luo M, Wang P, Bai D. Transversal changes, space closure, and efficiency of conventional and self-ligating appliances : A quantitative systematic review. J Orofac Orthop. 2018 Jan;79(1):1-10. doi: 10.1007/s00056-017-0110-4. Epub 2017 Nov 3.
Background: PubMed 27095145Yang X, Su N, Shi Z, Xiang Z, He Y, Han X, Bai D. Effects of self-ligating brackets on oral hygiene and discomfort: a systematic review and meta-analysis of randomized controlled clinical trials. Int J Dent Hyg. 2017 Feb;15(1):16-22. doi: 10.1111/idh.12220. Epub 2016 Apr 20.
Background: PubMed 28224175Yang X, He Y, Chen T, Zhao M, Yan Y, Wang H, Bai D. Differences between active and passive self-ligating brackets for orthodontic treatment : Systematic review and meta-analysis based on randomized clinical trials. J Orofac Orthop. 2017 Mar;78(2):121-128. doi: 10.1007/s00056-016-0059-8. Epub 2017 Feb 21.
Background: PubMed 29103440Qamruddin I, Alam MK, Mahroof V, Fida M, Khamis MF, Husein A. Effects of low-level laser irradiation on the rate of orthodontic tooth movement and associated pain with self-ligating brackets. Am J Orthod Dentofacial Orthop. 2017 Nov;152(5):622-630. doi: 10.1016/j.ajodo.2017.03.023.
Background: PubMed 27761668Nahas AZ, Samara SA, Rastegar-Lari TA. Decrowding of lower anterior segment with and without photobiomodulation: a single center, randomized clinical trial. Lasers Med Sci. 2017 Jan;32(1):129-135. doi: 10.1007/s10103-016-2094-5. Epub 2016 Oct 20.
Background: PubMed 27484605Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.
Background: PubMed 27129491Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
Background: PubMed 21478298Wahab RM, Idris H, Yacob H, Ariffin SH. Comparison of self- and conventional-ligating brackets in the alignment stage. Eur J Orthod. 2012 Apr;34(2):176-81. doi: 10.1093/ejo/cjq179. Epub 2011 Apr 8.
Background: PubMed 18929262Scott P, DiBiase AT, Sherriff M, Cobourne MT. Alignment efficiency of Damon3 self-ligating and conventional orthodontic bracket systems: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):470.e1-8. doi: 10.1016/j.ajodo.2008.04.018.
Individual participant dataSharing planned: No

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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.

Heba Al-Ibrahim, DDS principal investigator

MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria

Mohammad Y Hajeer, DDS MSc PhD study chair

Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Issam Khoury, DDS MSc PhD study director

Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Self-Ligating Brackets, Traditionally-Ligated Brackets and Corticotomy in people with Malocclusion of Anterior Teeth, run by Damascus University at 1 site in Syria.

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 10 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: finished, as of the sponsor's last update on 20 Nov 2020. 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 Syria. 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?

Duration of Alignment (time frame: This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months)). The study lists 7 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 NCT03647241, which also lists 9 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 20 Nov 2020.