Evaluation of the Skeletal, Dental and Soft-tissue Changes After En-masse Retraction of the Upper Anterior Teeth Stimulated by Low-intensity Electrical Current: A Single-centered, Randomized Controlled Clinical Trial
Abstract
Thirty-six patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study. They will be randomly assigned into two groups: low-intensity electrical stimulation group (LIES) and traditional retraction group (TRAD) after the leveling and alignment phase is completed. En-masse retraction will be initiated in both groups via closed nickel-titanium coil springs that applying 250 g of force on each side, Mini-implants will be inserted to provide the highest level of anchorage. The skeletal, dental, and soft tissue changes will be detected using lateral cephalometric radiographs, which will be obtained pretreatment, pre-, and post-en-masse retraction of the anterior teeth.
Conditions: Class II Division 1 Malocclusion.
Primary outcome: Duration of the en-masse retraction of anterior teeth; Change in the SNA angle; Change in the SNB angle; Change in the ANB angle; Change in the SNPog angle; Change in the SN-GoMe angle; Change in the MM angle; Change in the Bjork's sum; Change in Y-axis angle; Change in the SN-U1; Change in the GoMe-L1 angle; Change in the IIA angle; Change in the SV-U1E distance; Change in the SV-U1A distance; Change in the Nasolabial angle; Change in the labiomental angle; Change in the UL-E Line distance; Change in the LL-E Line distance.
Enrollment: 36 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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