NCT05362383

Use of TENS for the Recovery of Oral Function After Orthognathic Surgery

Use of Transcutaneous Electrical Nerve Stimulation (TENS) for the Recovery of Oral Function After Orthognathic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Oral functions of patients are markedly diminished immediately after orthognathic surgery, and novel approaches are needed to accelerate their recovery. The aim of this study is to examine the usefulness of weekly applications of transcutaneous electrical nerve stimulation (TENS) for this purpose, based on evidence of its effectiveness in other types of patients with muscle alterations. The main objective is to determine whether weekly TENS applications can increase the bite force and jaw opening in patients undergoing orthognathic surgery and decrease their pain and inflammation

Detailed description

A single-blind randomized clinical trial will be conducted in patients scheduled for orthognathic surgery, divided between experimental and control groups. Participants will be selected by non-probabilistic sampling of consecutive patients until the estimated sample size is reached. All patients have a skeletal and facial deformity amenable to surgery after a pre-surgical orthodontic period. Patients will be randomly assigned to the experimental group for TENS application or the control group for sham-TENS and the researcher responsible for data analyses will be blinded also. Four variables will be measured: Maximum Jaw Opening using a digital dental caliber, Bite force measured using Dental Prescale Fuji® film, Pain using a visual analog scale (VAS) and facial inflammation using a soft ruler adapted to the contour of the patient's face. Data will be gathered from all patients on jaw opening, bite force, inflammation, and pain before surgery and at 7, 14, 21, and 28 days post-surgery, conducting measurements both before and after the TENS/sham-TENS session. TENS will be applied in an identical manner to all patients in both groups and kept in position for the same time period (30 min); however, the device will be not switched on for the control group, and the stimulation intensity will be adjusted for those in the experimental group to the maximum that did not cause discomfort or areas of contraction, maintaining this stimulation intensity and frequency throughout the 30-min session. Each participant will submit to a weekly TENS a weekly TENS or sham-TENS session on the same day of the week during a four-week period

Conditions

• Orthognathic Surgery
• Physiology
• Transcutaneous Electric Nerve Stimulation

Interventions

Type	Name	Description
DEVICE	transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model	Will be used TENS device with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 milliampere. TENS electrodes (diameter 35-52 mm) will be placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the anterior temporal muscle. The device will be applied in an identical manner to all patients in both groups and kept in position for the same time period (30 min) and for the control group the the device will be not switched on

Timeline

• Start date: 2013-02-01
• Primary completion: 2018-05-18
• Completion: 2020-01-15
• First posted: 2022-05-05
• Last updated: 2022-05-11

Locations

1 site across 1 country: Spain