Clinical trial NCT05362383: Use of TENS for the Recovery of Oral Function After Orthognathic Surgery
Official title: Use of Transcutaneous Electrical Nerve Stimulation (TENS) for the Recovery of Oral Function After Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthognathic Surgery
Physiology
Transcutaneous Electric Nerve Stimulation
Keywords: oral function
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 47
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* programing of bimaxillary or mandibular orthognathic surgery
* no previous or concomitant surgery for temporo-mandibular disorders
* no presence of complex syndromes
* no presence of muscle or nervous disorders or receipt of medication for such disorders

Exclusion Criteria:

* impossibility to attend follow-up appointments
* refusal of informed consent

Primary outcomes:
measure: Bite force
timeFrame: Measurements will be taken baseline (before surgery)
measure: Bite force
timeFrame: Measurements will be taken at 7 days after surgery
measure: Bite force
timeFrame: Measurements will be taken at 14 days after surgery
measure: Bite force
timeFrame: Measurements will be taken at 21 days after surgery
measure: Bite force
timeFrame: Measurements will be taken at 28 days after surgery
measure: Jaw opening
timeFrame: Measurements will be taken baseline (before surgery)
measure: Jaw opening
timeFrame: Measurements will be taken at 7 days after surgery
measure: Jaw opening
timeFrame: Measurements will be taken at 14 days after surgery
measure: Jaw opening
timeFrame: Measurements will be taken at 21 days after surgery
measure: Jaw opening
timeFrame: Measurements will be taken at 28 days after surgery
measure: Pain (VAS)
timeFrame: Measurements will be taken baseline (before surgery)
measure: Pain (VAS)
timeFrame: Measurements will be taken at 7 days after surgery
measure: Pain (VAS)
timeFrame: Measurements will be taken at 14 days after surgery
measure: Pain (VAS)
timeFrame: Measurements will be taken at 21 days after surgery
measure: Pain (VAS)
timeFrame: Measurements will be taken at 28 days after surgery
measure: Inflammation
timeFrame: Measurements will be taken baseline (before surgery)
measure: Inflammation
timeFrame: Measurements will be taken at 7 days after surgery
measure: Inflammation
timeFrame: Measurements will be taken at 14 days after surgery
measure: Inflammation
timeFrame: Measurements will be taken at 21 days after surgery
measure: Inflammation
timeFrame: Measurements will be taken at 28 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Odontology, University Complutense
Study officials:
affiliation: Faculty of Odontology, University Complutense, Madrid
name: Alberto C Cacho, Prof
role: PRINCIPAL_INVESTIGATOR
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