search
Back to results

Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy (malocclusion)

Primary Purpose

Malocclusion, Class II Malocclusion

Status
Recruiting
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
clear aligners
traditional treatment Fixed appliances with class II elastics.
Sponsored by
Hama University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hama UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental : clear aligners with class II elastics technique

: traditional treatment Fixed appliances with class II elastics.

Arm Description

clear aligners technique A group of patients in which participants will be undergo to clear aligners treatment with class II elastics ( 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

A group 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
change in overbite
Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2023
Last Updated
September 20, 2023
Sponsor
Hama University
search

1. Study Identification

Unique Protocol Identification Number
NCT05684510
Brief Title
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Acronym
malocclusion
Official Title
Evaluation of Efficacy of Clear Aligners in Correction of Class II Malocclusion Using Intermaxillary Elastics: A Randomized Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2023 (Anticipated)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hama University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: a group of patients in which participants will be undergo to the clear aligners with class ii elastics. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.
Detailed 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: a group of patients in which participants will be undergo to the clear aligners with class ii elastics. 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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental : clear aligners with class II elastics technique
Arm Type
Experimental
Arm Description
clear aligners technique A group of patients in which participants will be undergo to clear aligners treatment with class II elastics ( 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
Arm Title
: traditional treatment Fixed appliances with class II elastics.
Arm Type
Experimental
Arm Description
A group 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.
Intervention Type
Device
Intervention Name(s)
clear aligners
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
traditional treatment Fixed appliances with class II elastics.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the SNA angle
Description
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.
Time Frame
: 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
Title
change in the SNB angle
Description
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.
Time Frame
: 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)
Title
change in ANB angle
Description
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.
Time Frame
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)
Title
change in SN.POG angle
Description
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.
Time Frame
: 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)
Title
change in the mandibular length [
Description
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.
Time Frame
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)
Title
change in SN.PP angle [
Description
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.
Time Frame
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)
Title
change in MP.SN angle
Description
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.
Time Frame
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)
Title
change in overjet
Description
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.
Time Frame
: 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)
Title
change in overbite
Description
Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fadi Jnaid
Phone
988499015
Email
Drfadijnaid@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
FATIMA NASHTR, MSc
Email
fatimahnashtar96@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FATIMA NASHTR, MSc
Organizational Affiliation
Hama University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rabab AlSabbag, Professor
Organizational Affiliation
Hama University
Official's Role
Study Director
Facility Information:
Facility Name
Hama University
City
Hama
Country
Syrian Arab Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fadi Jnaid
Phone
988499015
Email
Drfadijnaid@gmail.com
First Name & Middle Initial & Last Name & Degree
FATIMA NASHTR
Email
fatimahnashtar96@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy

We'll reach out to this number within 24 hrs