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Orthodontic Tooth MovementNCT05414019

Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics

A study testing Mini-screw, Utility arch and Nitinol reverse curve wire in people with Orthodontic Tooth Movement and Intrusion of Tooth, run by Al-Azhar University at 1 site in Egypt.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Evaluation of root resorption following different mandibular incisors intrusive mechanics : A randomized clinical trial Read more about this study

Who is it for?
Ages 12 to 16 yearsHealthy volunteers can take part
What is being tested?
Mini-screw, Utility arch and Nitinol reverse curve wire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteEgypt
Study dates
15 May 2025to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patient will be included in this study if has:
  • An age range between 12 and 16 years.
  • Deep overbite with excessive curve of Spee of more than 5mm
  • Over erupted lower incisors.
  • Permanent teeth are all present (except for third molar).
  • No previous orthodontic treatment.
  • No indications or symptoms of periodontal disease in the past or present, as determined by clinical and radiographic examination

Who cannot join

  • Patients who needed surgery to fix skeletal problems.
  • Any previous trauma or root canal therapy
  • Missing lower incisor.
  • Patients with congenital dentoskeletal disorders

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site
  • Al Azhar University

    Cairo

Other trials in Egypt

About this study

Official title: Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics : A Randomized Clinical Trial

Evaluation of root resorption following different mandibular incisors intrusive mechanics : A randomized clinical trial

Being tested
Mini-screw, Utility arch, Nitinol reverse curve wire
Keywords
Intrusion, Root resorption, Cone beam computed tomography, Utility Arch, Nitinol reverse curve wire, Miniscrew, Mandibular incisors
Medical subject headings
Root Resorption

What participants receive

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

  • Mini-screwOther

    7 patients will receive an intrusive force delivered by elastics from 2 mini-screws between mandibular lateral incisor and mandibular canine.

  • Utility archOther

    7 patients will receive an intrusive force delivered by intrusive utility arch.

  • Nitinol reverse curve wireOther

    7 patients will receive an intrusive force delivered by Nitinol reverse curve wire

Study groups in NCT05414019
Study groupRoleWhat they receive
Mini-screwActive comparator7 patients will receive an intrusive force delivered by elastics from 2 mini-screws between mandibular lateral incisor and mandibular canine.
Receives: Other: Mini-screw
Utility archActive comparator7 patients will receive an intrusive force delivered by intrusive utility arch.
Receives: Other: Utility arch
Nitinol reverse curve wireActive comparator7 patients will receive an intrusive force delivered by Nitinol reverse curve wire.
Receives: Other: Nitinol reverse curve wire

What is being measured

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

  1. Linear amount of root resorption

    Cone beam computed tomography linear measurements

    Measured: Change in Linear Root resorption at 6 months

  2. Volumetric amount of root resorption

    Cone beam computed tomography volumetric measurements

    Measured: Change in Volumetric Root resorption at 6 months

Timeline

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

  1. First posted10 Jun 2022
  2. Study start15 May 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
The total sample of patients will be randomly divided into three equal groups: Miniscrew: 7 patients will receive an intrusive force delivered by elastics from 2 miniscrews between mandibular lateral incisor and mandibular canine. Utility arch: 7 patients will receive an intrusive force delivered by intrusive utility arch. Nitinol reverse curve wire: 7 patients will receive an intrusive force delivered by Nitinol reverse curve wire.
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05414019
Sponsor's protocol ID
799/2234
Status last verified
Apr 2025
First submitted
29 May 2022
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Goel P, Tandon R, Agrawal KK. A comparative study of different intrusion methods and their effect on maxillary incisors. J Oral Biol Craniofac Res. 2014 Sep-Dec;4(3):186-91. doi: 10.1016/j.jobcr.2014.11.007. Epub 2014 Dec 6.

    PubMed 25737942
  • Hamdan AM, Lewis SM, Kelleher KE, Elhady SN, Lindauer SJ. Does overbite reduction affect smile esthetics? Angle Orthod. 2019 Nov;89(6):847-854. doi: 10.2319/030819-177.1. Epub 2019 Jul 15.

    PubMed 31306077
  • Piancino MG, Tortarolo A, Di Benedetto L, Crincoli V, Falla D. Chewing Patterns and Muscular Activation in Deep Bite Malocclusion. J Clin Med. 2022 Mar 19;11(6):1702. doi: 10.3390/jcm11061702.

    PubMed 35330027
  • Nielsen IL. Vertical malocclusions: etiology, development, diagnosis and some aspects of treatment. Angle Orthod. 1991 Winter;61(4):247-60. doi: 10.1043/0003-3219(1991)0612.0.CO;2.

    PubMed 1763835
  • Sonnesen L, Svensson P. Temporomandibular disorders and psychological status in adult patients with a deep bite. Eur J Orthod. 2008 Dec;30(6):621-9. doi: 10.1093/ejo/cjn044. Epub 2008 Aug 5.

    PubMed 18684706
  • Guven BA, Ciger S. Evaluation of the Effect of Fixed Anterior Biteplane Treatment on Temporomandibular Joint in Patients with Deep Bite. Turk J Orthod. 2020 Mar 1;33(1):8-12. doi: 10.5152/TurkJOrthod.2020.19108. eCollection 2020 Mar.

    PubMed 32284893
  • Millett DT, Cunningham SJ, O'Brien KD, Benson PE, de Oliveira CM. Orthodontic treatment for deep bite and retroclined upper front teeth in children. Cochrane Database Syst Rev. 2018 Feb 1;2(2):CD005972. doi: 10.1002/14651858.CD005972.pub4.

    PubMed 29390172
  • Nanda R. The differential diagnosis and treatment of excessive overbite. Dent Clin North Am. 1981 Jan;25(1):69-84. No abstract available.

    PubMed 6937401
  • Burstone CR. Deep overbite correction by intrusion. Am J Orthod. 1977 Jul;72(1):1-22. doi: 10.1016/0002-9416(77)90121-x.

    PubMed 267433

Questions about this trial

What is this clinical trial studying?

A study testing Mini-screw, Utility arch and Nitinol reverse curve wire in people with Orthodontic Tooth Movement and Intrusion of Tooth, run by Al-Azhar University at 1 site in Egypt.

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: enrolling by invitation, as of the sponsor's last update on 25 Apr 2025. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

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?

Linear amount of root resorption (time frame: Change in Linear Root resorption at 6 months). The study lists 2 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 NCT05414019, 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 25 Apr 2025.

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