Pain, Discomfort, and Acceptance During Using Electrical Stimulation to Accelerate Orthodontic Teeth Movement

Class II Malocclusion, Division 1 Clinical Trial

Official title: Evaluation of Patient-reported Outcome Measures (PROMs) During Accelerating the En-masse Retraction of Upper Anterior Teeth Using a Low-intensity Direct Electrical Current: A Randomized Controlled Clinical Trial

Status Completed

Clinical Trial Summary

Forty patients with class II division 1 malocclusion who will require extraction of the upper first premolars as a part of the orthodontic treatment plan will be invited to participate in the study. They will be divided randomly into two groups: the electrical group and the control group. The en-masse retraction technique will be used to retract the upper anterior teeth using mini-implants as an anchor unit to provide the maximum anchorage and Nickle-Titanium closed coil springs that will be stretched from the mini-implants to the crimpable hooks on the base wire and applied 250 g of force per side. A special removable electrical device will be used to provide electrical stimulation during the retraction phase. The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales.

Clinical Trial Description

Participants will be chosen from the patients attending the Department of Orthodontics in the Faculty of Dentistry at Damascus University. patients will be examined by the researcher, and any patient with class II division I malocclusion who meets the inclusion criteria will invite to participate in this trial. After giving them the information sheet, informed consent will be obtained from all patients who agreed to join the study. Leveling and alignment will be performed using pre-adjusted fixed orthodontic appliances of 0.022 x 0.028-inch slot metal bracket with MBT prescription; the conventional wiring sequence will be followed until a 0.019 x 0.025 Stainless Steel base wire is attached. The maxillary first premolars will be extracted, and skeletal anchoring will be applied before leveling and alignment will begin for all patients. self-drilling orthodontic mini-implants (diameter: 1.6 mm; length: 8 mm) will be placed between the roots of the maxillary second premolar and the first molar on each side. The en-masse retraction will be done using Nickle-Titanium (NiTi) closed coil springs that stretched from crimpable hooks on the base wire to the mini-implants and applied 250 g of force per side. The force will be examined using a force gauge at every appointment (two weeks) until the completion of the retraction of the upper anterior (reaching a class I canine relationship and a correct incisor relationship). A micro electrical current will be applied on the upper anterior teeth area using a removable intraorally device containing a small electrical circuit. Each patient in the experimental group will be asked to apply the electric accelerating device in the mouth for 5 hours daily. The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales. 24 hours following the springs activation (T1), three days (T2), and one week (T3). ;

Related Conditions & MeSH terms

• Class II Malocclusion, Division 1
• Malocclusion
• Malocclusion, Angle Class II

• NCT number: NCT05920525
• Study type: Interventional
• Source: Damascus University
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Completion date: May 15, 2023