Clinical trial NCT05684510: Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Official title: Evaluation of Efficacy of Clear Aligners in Correction of Class II Malocclusion Using Intermaxillary Elastics: A Randomized Controlled
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malocclusion
Class II Malocclusion
Lead sponsor: Hama University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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

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.

Primary outcomes:
measure: Change in the SNA angle
timeFrame: : 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
measure: change in the SNB angle
timeFrame: : 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)
measure: change in ANB angle
timeFrame: 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)
measure: change in SN.POG angle
timeFrame: : 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)
measure: change in the mandibular length [
timeFrame: 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)
measure: change in SN.PP angle [
timeFrame: 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)
measure: change in MP.SN angle
timeFrame: 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)
measure: change in overjet
timeFrame: : 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)
measure: change in overbite
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Hama
country: Syrian Arab Republic
facility: Hama University
Study officials:
affiliation: Hama University
name: FATIMA NASHTR, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hama University
name: Rabab AlSabbag, Professor
role: STUDY_DIRECTOR
References: