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Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics

Primary Purpose

Orthodontic Tooth Movement, Intrusion of Tooth, Resorption, Root

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Mini-screw

Utility arch

Nitinol reverse curve wire

About this trial

This is an interventional basic science trial for Orthodontic Tooth Movement focused on measuring Intrusion, Root resorption, Cone beam computed tomography, Utility Arch, Nitinol reverse curve wire, Miniscrew, Mandibular incisors

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Al Azhar University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Mini-screw

Utility arch

Nitinol reverse curve wire

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Linear amount of root resorption

Cone beam computed tomography linear measurements

Volumetric amount of root resorption

Cone beam computed tomography volumetric measurements

Secondary Outcome Measures

Full Information

NCT ID

NCT05414019

First Posted

May 29, 2022

Last Updated

May 26, 2023

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT05414019

Brief Title

Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

March 15, 2024 (Anticipated)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthodontic Tooth Movement, Intrusion of Tooth, Resorption, Root

Keywords

Intrusion, Root resorption, Cone beam computed tomography, Utility Arch, Nitinol reverse curve wire, Miniscrew, Mandibular incisors

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking Description

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).

Allocation

Randomized

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mini-screw

Arm Type

Active Comparator

Arm Description

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

Arm Title

Utility arch

Arm Type

Active Comparator

Arm Description

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

Arm Title

Nitinol reverse curve wire

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Mini-screw

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Utility arch

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Nitinol reverse curve wire

Intervention Description

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

Primary Outcome Measure Information:

Title

Linear amount of root resorption

Description

Cone beam computed tomography linear measurements

Time Frame

Change in Linear Root resorption at 6 months

Title

Volumetric amount of root resorption

Description

Cone beam computed tomography volumetric measurements

Time Frame

Change in Volumetric Root resorption at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud S Nassar, student

Organizational Affiliation

Al-Azhar University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Al Azhar University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

25737942

Citation

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.

Results Reference

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PubMed Identifier

31306077

Citation

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.

Results Reference

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PubMed Identifier

35330027

Citation

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.

Results Reference

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PubMed Identifier

1763835

Citation

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. Erratum In: Angle Orthod 1992 Summer;62(2):87.

Results Reference

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PubMed Identifier

18684706

Citation

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.

Results Reference

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PubMed Identifier

32284893

Citation

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.

Results Reference

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PubMed Identifier

29390172

Citation

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.

Results Reference

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PubMed Identifier

6937401

Citation

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

Results Reference

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PubMed Identifier

267433

Citation

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

Results Reference

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Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics

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