Crowding of Anterior Mandibular TeethNCT04988373

Evaluation of the Efficiency of Single Aligner Appliance for Treatment of Mild Crowding Cases in Adults.

A study testing Modified aligner appliance and Traditional fixed appliance in people with Crowding of Anterior Mandibular 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

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Trial summary

36 participants who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups. 1. In the experimental group, patients will be treated using single aligner appliance in order to align their crowding teeth. 2. Read more about this study

Who is it for?: Ages 16 to 28 years
Conditions the study is for: Crowding of Anterior Mandibular Teeth
What is being tested?: Modified aligner appliance and Traditional fixed appliance
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSyria
Study dates: 23 Jul 2021to 20 Sep 2022
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 16 to 28 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Adults patients aged between (16 - 28) years.
Class I malocclusion with Mild crowding (1 - 4) mm in the anterior region of the mandibular dental arch
All lower teeth are existed (except for third molars).
No congenitally missing or extracted teeth (except for third molars)
Patients have not undergone previous orthodontic treatment.
Patient with good oral hygiene (Plaque Index less than 1).
With no severe skeletal discrepancy.

Who cannot join

Bimaxillary dentoalveolar severe protrusion.
Any systemic diseases affect teeth movement.
Bad oral hygiene.
Patient lack of commitment toward follow-up appointments.

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Orthodontics, University of Damascus Dental School
Damascus

Other trials in Syria

About this study

Official title: Evaluation of the Efficiency of Modified Aligner Appliance With NiTi Springs for Treatment of Mild Crowding Cases in Adults.

36 participants who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups.

In the experimental group, patients will be treated using single aligner appliance in order to align their crowding teeth.
Control group will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Read the detailed description

Most adult patients do not prefer traditional fixed appliances for aesthetic reasons, long treatment duration, and relatively difficult oral care. The current study came in order to evaluate the Efficiency of a new single aligner appliance that is both aesthetic and economical.

Conditions: Crowding of Anterior Mandibular Teeth
Being tested: Modified aligner appliance, Traditional fixed appliance
Keywords: Mild crowding, Aligner, Orthodontic treatment, Crowded anterior teeth

What participants receive

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

Modified aligner applianceDevice
Patients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.
Traditional fixed applianceDevice
Patients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Study groups in NCT04988373
Study group	Role	What they receive
Single aligner appliance	Experimental	Modified aligner appliance with NiTi springs Receives: Device: Modified aligner appliance
Traditional fixed appliances	Active comparator	MBT-prescription of metallic brackets. Receives: Device: Traditional fixed appliance

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: The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 4 to 6 months
Change in Little's Index of Irregularity
The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding.
The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.
Measured: T0: immediately before the start of orthodontic 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 Lower Incisors Inclination
The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured using Cephalometric x ray.
Measured: immediately before the start of orthodontic treatment; T1: at the end of the alignment stage which is expected to happen within 4 to 6 months

Timeline

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

23 Jul 202120 Sep 2022

First posted3 Aug 2021
Study start23 Jul 2021
Primary completion28 Jan 2022
Study completion20 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Crowding of Anterior Mandibular 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04988373
Sponsor's protocol ID: UDDS-Ortho-06-2021
Status last verified: May 2024
First submitted: 23 Jul 2021
Last updated: 2 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Barrer HG. Protecting the integrity of mandibular incisor position through keystoning procedure and spring retainer appliance. J Clin Orthod. 1975 Aug;9(8):486-94. No abstract available.
PubMed 1072074
Qureshi A. The Inman Aligner for anterior tooth alignment. Dent Update. 2008 Oct;35(8):569-71, 574-6. doi: 10.12968/denu.2008.35.8.569.
PubMed 19055094
Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.
PubMed 1059332
Hennessy J, Al-Awadhi EA. Clear aligners generations and orthodontic tooth movement. J Orthod. 2016 Mar;43(1):68-76. doi: 10.1179/1465313315Y.0000000004.
PubMed 25939782
Hennessy J, Al-Awadhi EA. Clear aligners generations and orthodontic tooth movement. J Orthod. 2016 Jan 8:1-9. doi: 10.1080/14653125.2015.1108725. Online ahead of print.
PubMed 26743036
Alhafi ZM, Rajeh N. Evaluation of the effectiveness of modified aligner appliance with nickel-titanium springs in treatment of mild crowding of lower incisors: A randomized controlled clinical trial. J World Fed Orthod. 2022 Aug;11(4):107-113. doi: 10.1016/j.ejwf.2022.04.003. Epub 2022 May 24.
PubMed 35624004

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

Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Active, not recruiting
Effects of Laser Therapy and Vitamin D Pills on Braces Tooth Movement: A Random Controlled Study
Malocclusion of Anterior Teeth

All Crowding of Anterior Mandibular Teeth trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficiency of Modified Aligner Appliance With NiTi Springs for Treatment of Mild Crowding Cases in Adults.
ClinicalTrials.gov ID: NCT04988373
Acronym / sponsor ID: UDDS-Ortho-06-2021
Conditions: Crowding of Anterior Mandibular Teeth
Keywords: Mild crowding, Aligner, Orthodontic treatment, Crowded anterior teeth
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 23 Jul 2021 (actual)
Primary completion: 28 Jan 2022 (actual)
Study completion: 20 Sep 2022 (actual)
First posted: 3 Aug 2021 (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.

36 participants who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups.

In the experimental group, patients will be treated using single aligner appliance in order to align their crowding teeth.
Control group will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Single aligner appliance	Experimental	Device: Modified aligner applianceModified aligner appliance with NiTi springs
Traditional fixed appliances	Active comparator	Device: Traditional fixed applianceMBT-prescription of metallic brackets.

Who may qualify

Ages: 16 to 28 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Adults patients aged between (16 - 28) years.
Class I malocclusion with Mild crowding (1 - 4) mm in the anterior region of the mandibular dental arch
All lower teeth are existed (except for third molars).
No congenitally missing or extracted teeth (except for third molars)
Patients have not undergone previous orthodontic treatment.

Key exclusion criteria (4 listed)

Bimaxillary dentoalveolar severe protrusion.
Any systemic diseases affect teeth movement.
Bad oral hygiene.
Patient lack of commitment toward follow-up appointments.

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
Modified aligner appliancePatients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.	Device	Single aligner appliance
Traditional fixed appliancePatients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.	Device	Traditional fixed appliances

Primary outcome

Duration of Alignment
Time frame: The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 4 to 6 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 of Irregularity
Time frame: T0: immediately before the start of orthodontic 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 lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.
Change in Lower Incisors Inclination
Time frame: immediately before the start of orthodontic treatment; T1: at the end of the alignment stage which is expected to happen within 4 to 6 months
The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured using Cephalometric x ray.

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 2 May 2024.
Background: PubMed 1072074Barrer HG. Protecting the integrity of mandibular incisor position through keystoning procedure and spring retainer appliance. J Clin Orthod. 1975 Aug;9(8):486-94. No abstract available.
Background: PubMed 19055094Qureshi A. The Inman Aligner for anterior tooth alignment. Dent Update. 2008 Oct;35(8):569-71, 574-6. doi: 10.12968/denu.2008.35.8.569.
Background: PubMed 1059332Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.
Background: PubMed 25939782Hennessy J, Al-Awadhi EA. Clear aligners generations and orthodontic tooth movement. J Orthod. 2016 Mar;43(1):68-76. doi: 10.1179/1465313315Y.0000000004.
Background: PubMed 26743036Hennessy J, Al-Awadhi EA. Clear aligners generations and orthodontic tooth movement. J Orthod. 2016 Jan 8:1-9. doi: 10.1080/14653125.2015.1108725. Online ahead of print.
Derived from this study: PubMed 35624004Alhafi ZM, Rajeh N. Evaluation of the effectiveness of modified aligner appliance with nickel-titanium springs in treatment of mild crowding of lower incisors: A randomized controlled clinical trial. J World Fed Orthod. 2022 Aug;11(4):107-113. doi: 10.1016/j.ejwf.2022.04.003. Epub 2022 May 24.
Individual participant dataSharing planned: No

Related trials for Crowding of Anterior Mandibular Teeth

Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Active, not recruiting
Effects of Laser Therapy and Vitamin D Pills on Braces Tooth Movement: A Random Controlled Study
Malocclusion of Anterior Teeth

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.

Ziad M Alhafi, DDS principal investigator

MSc student at the Orthodontic Department, University of Damascus Dental

Nada Rajeh, DDS,MSc,PhD study chair

Professor of Orthodontics, 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 Modified aligner appliance and Traditional fixed appliance in people with Crowding of Anterior Mandibular 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 7 inclusion and 4 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 2 May 2024. 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: The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 4 to 6 months). The study lists 3 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 NCT04988373, which also lists 6 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 2 May 2024.