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

A Prospective Randomized Clinical Trial to Compare Between Two Leveling and Alignment Protocols for the Treatment of Class II Division 2 Malocclusion

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.

Study Overview

• Status: Completed
• Conditions: Class II Div 2 Incisal Relationship
• Intervention / Treatment: Device: Fixed appliance

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan
    • Jordan University of science and technology Dental Teaching Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Fixed appliance
Experimental: 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.	Device: Fixed appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of treatment	Measurements of time of treatment in months	2 years
Pain perception	Using visual analogue scale. From 0 where is no pain to 10 with severe pain	2 years

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Investigators: Principal Investigator: Susan AlKhateeb, PhD, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Class II division 2; Alignment; Leveling
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 461/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No