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
Sponsored by
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
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
Active Comparator
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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
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Results Reference
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Citation
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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.
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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.
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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.
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PubMed Identifier
32284893
Citation
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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.
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PubMed Identifier
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Citation
Nanda R. The differential diagnosis and treatment of excessive overbite. Dent Clin North Am. 1981 Jan;25(1):69-84. No abstract available.
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PubMed Identifier
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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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