NCT05652244

Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction

Evaluation of Pain, Discomfort and Functional Impairment Associated With the Two-step Retraction Technique Anchored With Transpalatal Arches Versus the en Masse Retraction of Upper Anterior Teeth Anchored With Mini-implants: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 17 Years – 27 Years
• Healthy volunteers: Not accepted

Summary

Thirty-eight patients requiring extraction of maxillary first premolars will participate in the study. They will be divided randomly into two groups: an en-masse retraction group and a two-step group. In each group, anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, Mini-implants will be used as an anchor unit in the en-masse retraction group, and TPA in the two-step's retraction group. The levels of pain, discomfort, and functional impairments will be self-reported using a validated questionnaire with a 4-points Likert scale.

Detailed description

Pain associated with orthodontic treatment is one of the undesirable complications, which negatively affects the patient's cooperation. Pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces. The perception of pain is affected by many factors related to the patient, such as age, gender, and any previous treatment experiences, which are negatively or positively reflected in the patient's cooperation. As for the factors related to the type of orthodontic treatment provided. The levels of pain and discomfort vary with the different anchorage systems used during orthodontic treatment. Several methods have been proposed to assure good anchorages, such as headgear, transpalatal arch (TPA) with or without a Nance button, lingual arches, bonding of second molars, or intermaxillary elastics, and recently mini-implants. The use of mini-implants has recently become more common. The mini-implants have been used to secure absolute anchorage in en-mass retraction, canine retraction, total arch distalization, and anterior teeth intrusion. The most common usage is en-mass retraction of anterior teeth.

Conditions

• Class II Malocclusion

Interventions

Type	Name	Description
DEVICE	Mini-implants	En masse retraction of upper anterior teeth will be applied where mini-implants will be used as an anchor unit. Anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.
DEVICE	Transpalatal arche (TPA)	Two-step retraction of upper anterior teeth will be applied where transpalatal arches (TPAs) will be used as an anchor unit. Teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.

Timeline

• Start date: 2013-01-13
• Primary completion: 2014-05-03
• Completion: 2015-01-24
• First posted: 2022-12-15
• Last updated: 2022-12-15

Locations

1 site across 1 country: Syria