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Recruiting NCT05684510

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

No phase Interventional Malocclusion Class II Malocclusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: clear aligners, traditional treatment Fixed appliances with class II elastics..
Who it may be relevant to
Registry conditions: Malocclusion, Class II Malocclusion. Basic parameters: 15 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Syria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Efficacy of Clear Aligners in Correction of Class II Malocclusion Using Intermaxillary Elastics: A Randomized Controlled

Overview

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.

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:

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

Interventions

  • 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
  • Device 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.

Primary outcome measures

  • Change in the SNA angle [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]
  • change in the SNB angle [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)]
  • change in ANB angle [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)]
  • change in SN.POG angle [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)]
  • change in the mandibular length [ [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)]
  • change in SN.PP angle [ [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)]
  • change in MP.SN angle [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)]
  • change in overjet [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)]
  • change in overbite [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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Syria · 1 center
  • Hama University — Hama

Identifiers

NCT: NCT05684510 · Hama University -

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗