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

NCT03833739 | Completed

• 1 other identifier: 461/2017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Div 2 Incisal Relationship

Keywords

Class II division 2; Alignment; Leveling

Outcome Measures

Primary Outcomes (1)

• Upper and lower incisors proclination

  Cephalometric analysis. Treatment changes in the values for upper and lower incisors in degrees, Upper incisor /Maxillary plane in degrees and lower incisors/Mandibular plane in degrees.

  2 years

Secondary Outcomes (2)

• Duration of treatment

  2 years

• Pain perception

  2 years

Study Arms (2)

Upper Arch Treatment First

EXPERIMENTAL

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.

Device: Fixed appliance

Lower Arch Treatment First

EXPERIMENTAL

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.

Device: Fixed appliance

Interventions

Fixed appliance DEVICE

Lower Arch Treatment First; Upper Arch Treatment First

Eligibility Criteria

• Age: 17 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of Science and Technology Dental Teaching Clinics

Irbid, Jordan

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Susan AlKhateeb, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Master student

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

JO (1)