Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics

Sponsor

Al-Azhar University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05414019

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Tooth Movement Intrusion of Tooth Resorption, Root	Other: Mini-screw Other: Utility arch Other: Nitinol reverse curve wire	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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).

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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.	Other: Mini-screw 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.	Other: Utility arch 7 patients will receive an intrusive force delivered by intrusive utility arch.
Active Comparator: Nitinol reverse curve wire 7 patients will receive an intrusive force delivered by Nitinol reverse curve wire.	Other: Nitinol reverse curve wire 7 patients will receive an intrusive force delivered by Nitinol reverse curve wire

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.

Other: Mini-screw

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.

Other: Utility arch

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

Active Comparator: Nitinol reverse curve wire

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

Other: Nitinol reverse curve wire

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

Outcome Measures

Primary Outcome Measures

Linear amount of root resorption [Change in Linear Root resorption at 6 months]
Cone beam computed tomography linear measurements
Volumetric amount of root resorption [Change in Volumetric Root resorption at 6 months]
Cone beam computed tomography volumetric measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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