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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05684510
Other study ID # Hama University -
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 25, 2023
Est. completion date January 1, 2024

Study information

Verified date July 2023
Source Hama University
Contact Fadi Jnaid
Phone 988499015
Email Drfadijnaid@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances. There are two group: 1. a group of patients in which participants will be undergo to the clear aligners with class ii elastics. 2. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.


Description:

Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances. There are two group: 1. a group of patients in which participants will be undergo to the clear aligners with class ii elastics. 2. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics. phase Intervention/treatment Condition or disease Not applicable Other: clear aligners Technique with class ii elastics. Other: fixed multibracket appliances with class ii elastics Malocclusion Class ii Division 1 malocclusion


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date January 1, 2024
Est. primary completion date December 11, 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years to 20 Years
Eligibility Inclusion Criteria: - - Patients with permanent occlusion at age 15-20 years. - Patients with class II division I (half cusp or Less) with moderate overjet (2-4mm). - Patients with normal or horizontal growth pattern. - Mild crowding (_<2 mm) in maxillary and mandibular arch. - Patient with satisfactory periodontal health and good oral hygiene - No previous orthodontic treatment - Comprehensive medical and dental history ruling out any systemic disease. Exclusion Criteria: - Patients with periodontal disease. - Patients with vertical growth pattern. - Patients with missing or extracted teeth except third molar. - Patients with temporomandibular joint disorder. - Patients with Skeletal open bite. - Patients with poor oral and gingival health - Patients with neuromuscular disorder. - Patients with severe skeletal class II.

Study Design


Intervention

Device:
clear aligners
clear aligners will be applied to the upper and lower arch, then a class II elastics 1\4 and 6,5 oz will be use from the precision-cut Hook on the maxillary aligner to the button of mandibular first molar
traditional treatment Fixed appliances with class II elastics.
Agroup of patients in which participants will be undergo to the fixed multibracket treatment (with slot size 0.022 × 0.028 and MBT prescription , after completing leveling and alignment , Elastics will be applied from the hooks of canines brackets to the hooks of lower first molar when the 0.019× 0.025-inch stainless steel archwires placed.

Locations

Country Name City State
Syrian Arab Republic Hama University Hama

Sponsors (1)

Lead Sponsor Collaborator
Hama University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the SNA angle This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group
Primary change in the SNB angle This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved(expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary change in ANB angle This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary change in SN.POG angle This angle the represents the position of the chin bone in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. : T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary change in the mandibular length [ Amount of distance measured from the Co point to Gn point in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. T0: 1day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary change in SN.PP angle [ This angle the represents the amount and direction of rotation of the upper jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary change in MP.SN angle This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary change in overjet Represents The distance between the most anterior point on the lower incisor to the most anterior point on the upper incisor in the cephalometric analysis. : T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary change in overbite Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis. T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
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