- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414019
Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics
May 26, 2023 updated by: Mahmoud Salah Mahmoud Ali Nassar, Al-Azhar University
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
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- Al Azhar University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mini-screw
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 elastics from 2 mini-screws between mandibular lateral incisor and mandibular canine.
|
Active Comparator: Utility arch
7 patients will receive an intrusive force delivered by intrusive utility arch.
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7 patients will receive an intrusive force delivered by intrusive utility arch.
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Active Comparator: Nitinol reverse curve wire
7 patients will receive an intrusive force delivered by Nitinol reverse curve wire.
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7 patients will receive an intrusive force delivered by Nitinol reverse curve wire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Linear amount of root resorption
Time Frame: Change in Linear Root resorption at 6 months
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Cone beam computed tomography linear measurements
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Change in Linear Root resorption at 6 months
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Volumetric amount of root resorption
Time Frame: Change in Volumetric Root resorption at 6 months
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Cone beam computed tomography volumetric measurements
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Change in Volumetric Root resorption at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mahmoud S Nassar, student, Al-Azhar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Nanda R. The differential diagnosis and treatment of excessive overbite. Dent Clin North Am. 1981 Jan;25(1):69-84. No abstract available.
- Burstone CR. Deep overbite correction by intrusion. Am J Orthod. 1977 Jul;72(1):1-22. doi: 10.1016/0002-9416(77)90121-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 15, 2024
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 29, 2022
First Submitted That Met QC Criteria
June 8, 2022
First Posted (Actual)
June 10, 2022
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 26, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 799/2234
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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