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

Class II Div 2 Incisal Relationship Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833739
• Other study ID #: 461/2017
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: November 1, 2018

Study information

• Verified date: February 2019
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Div 2 Incisal Relationship
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• Fixed appliance

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology Dental Teaching Clinics	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of treatment	Measurements of time of treatment in months	2 years
Secondary	Pain perception	Using visual analogue scale. From 0 where is no pain to 10 with severe pain	2 years