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

Primary Purpose

Class II Div 2 Incisal Relationship

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Fixed appliance
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Div 2 Incisal Relationship focused on measuring Class II division 2, Alignment, Leveling

Eligibility Criteria

17 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jordan University of Science and Technology Dental Teaching Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upper Arch Treatment First

Lower Arch Treatment First

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of treatment
Measurements of time of treatment in months
Pain perception
Using visual analogue scale. From 0 where is no pain to 10 with severe pain

Full Information

First Posted
February 6, 2019
Last Updated
February 20, 2019
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03833739
Brief Title
Comparison Between 2 Protocols for the Treatment of Class II Division 2 Malocclusion
Official Title
A Prospective Randomized Clinical Trial to Compare Between Two Leveling and Alignment Protocols for the Treatment of Class II Division 2 Malocclusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Div 2 Incisal Relationship
Keywords
Class II division 2, Alignment, Leveling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upper Arch Treatment First
Arm Type
Experimental
Arm Description
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.
Arm Title
Lower Arch Treatment First
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fixed appliance
Primary Outcome Measure Information:
Title
Upper and lower incisors proclination
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Duration of treatment
Description
Measurements of time of treatment in months
Time Frame
2 years
Title
Pain perception
Description
Using visual analogue scale. From 0 where is no pain to 10 with severe pain
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan AlKhateeb, PhD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology Dental Teaching Clinics
City
Irbid
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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