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Completed

NCT Number: NCT03833739

Comparison Between 2 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.

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Key information

Conditions

Class II Div 2 Incisal Relationship Malocclusion Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

17 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology Dental Teaching Clinics

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fixed appliance

Device

Primary outcomes

  1. Upper and lower incisors proclination

    Time frame: 2 years

    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 outcomes

  1. Duration of treatment

    Time frame: 2 years

    Measurements of time of treatment in months

  2. Pain perception

    Time frame: 2 years

    Using visual analogue scale. From 0 where is no pain to 10 with severe pain

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2019
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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