NCT05414019

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
2.9 years until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

May 29, 2022

Last Update Submit

April 23, 2025

Conditions

Keywords

IntrusionRoot resorptionCone beam computed tomographyUtility ArchNitinol reverse curve wireMiniscrewMandibular incisors

Outcome Measures

Primary Outcomes (2)

  • Linear amount of root resorption

    Cone beam computed tomography linear measurements

    Change in Linear Root resorption at 6 months

  • Volumetric amount of root resorption

    Cone beam computed tomography volumetric measurements

    Change in Volumetric Root resorption at 6 months

Study Arms (3)

Mini-screw

ACTIVE COMPARATOR

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

Other: Mini-screw

Utility arch

ACTIVE COMPARATOR

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

Other: Utility arch

Nitinol reverse curve wire

ACTIVE COMPARATOR

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

Other: Nitinol reverse curve wire

Interventions

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

Mini-screw

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

Utility arch

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

Nitinol reverse curve wire

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University

Cairo, Egypt

Location

Related Publications (9)

  • 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.

    PMID: 25737942BACKGROUND
  • 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.

    PMID: 31306077BACKGROUND
  • 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.

    PMID: 35330027BACKGROUND
  • 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.

    PMID: 1763835BACKGROUND
  • 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.

    PMID: 18684706BACKGROUND
  • 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.

    PMID: 32284893BACKGROUND
  • 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.

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

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

    PMID: 267433BACKGROUND

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Officials

  • Mahmoud S Nassar, student

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Observation: Each patient will be followed up on periodic base for progress evaluation and integrity checks, as well as root resorption will be evaluated using CBCT images taken before and after the intrusion. Ethical considerations: An informed consent form (attached copy) that explains every step in the research will be given and discussed carefully with the patient and his/her parents before participation in the study and should be signed freely. The objectives of the study will be discussed and explained with the patients and / or their guardians and they will receive a copy of the consent form as well. Data management and analysis: The data will be collected, tabulated, and statistically analyzed using Statistical Package for Social Sciences (SPSS program, version 18, Inc., Chicago, III).
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 29, 2022

First Posted

June 10, 2022

Study Start

May 15, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations