Comparison Between 2 Protocols for the Treatment of Class II Division 2 Malocclusion

NCT ID: NCT03833739

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-11-01

Brief Summary

The aim of this prospective study was to compare between two different treatment modalities of class II division 2; to start treatment in upper arch first until adequate overjet is obtained or to start in the lower arch first with removable anterior bite plane in upper arch.

Detailed Description

Fifty four subjects with class II division 2 participated in this study. The subjects were randomly divided into two groups; Group one (28 patients): orthodontic treatment with upper arch bond up first and lower arch was bonded when 4 mm overjet was reached. The treatment continued until 0.019 x 0.025 " stainless steel wires were reached in both arches. Group 2 (26 patients): orthodontic treatment with lower arch bond up first with removable anterior bite plane in upper arch. When 0.019 x 0.025" stainless steel wire was reached, the upper arch was bonded. The treatment continued until 0.019 x 0.025" stainless steel wires were reached. Three cephalograms were taken for each patient in both groups; pretreatment (T0) , after bonding the other arch (T1) and at the end of leveling and alignment in both arches (T2). Cephalometric measurements and superimpositions were made. Skeletal and dentoalveolar treatment changes were compared within and between the 2 groups.

Conditions

Class II Div 2 Incisal Relationship

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Upper Arch Treatment First

Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the upper and lower arches.

starting treatment in the upper arch The upper ach was bonded for 28 patients and teeth alignment was started using round 0.014"NiTi arch wire. The 0.014"NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. Orthodontic treatment was continued in the upper arch with arch wire sequence of 0.014"NiTi, 0.018"NiTi, 0.016"X0.022"NiTi, 0.019"X0.025"NiTi, and 0.019"X0.025"stainless steel arch wires. The patients were followed up on a monthly basis until sufficient proclination of the upper incisors achieved to establish an overjet of at least 4 mm. After reaching the full working arch wire in lower arch (0.019" X 0.025"stainless steel wire), lateral cephalogram and study models were taken.

Group Type: EXPERIMENTAL

Fixed appliance

Intervention Type: DEVICE

Lower Arch Treatment First

Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the lower arch and anterior bite plate in the upper arch.

The lower arch was bonded after taking the pretreatment records. At the same appointment an anterior bite plate in the upper arch was delivered to prevent shearing off the mandibular incisor brackets and help in correction of anterior deep bite .After lower arch alignment and leveling in the same arch wire sequence as the other group and 0.019" X 0.025"stainless steel arch wire was reached, the anterior bite plate was removed and the upper arch was bonded. The same arch wire sequence was used in the upper arch as was used in the lower arch. When the full working arch wire (0.019" X 0.025"stainless steel arch wire) was reached in the upper arch, study models and lateral cephalogram were taken.

Group Type: EXPERIMENTAL

Fixed appliance

Intervention Type: DEVICE

Interventions

Fixed appliance

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 17 years and ≤ 26 years
• Class II division 2 malocclusion.
• Overjet (OJ) < 4 mm.
• Overbite (OB) covering more than half of the lower incisor height.
• Mild to moderate crowding with tooth contact displacement no more than 2 mm.
• Good oral hygiene and healthy periodontium.

Exclusion Criteria

• Systemic health problems and medications were taken.
• History of previous orthodontic treatment.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud abuaysheh

Principal Investigator - Master student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan AlKhateeb, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Jordan University of Science and Technology Dental Teaching Clinics

Irbid, , Jordan

Countries

Jordan

Other Identifiers

461/2017

Identifier Type: -

Identifier Source: org_study_id