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

Orthognathic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362383
• Other study ID #: C.P. - C.I. 12/136-E
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: January 15, 2020

Study information

• Verified date: May 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 15, 2020
• Est. primary completion date: May 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthognathic Surgery
• Physiology
• Transcutaneous Electric Nerve Stimulation

Intervention

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

Locations

Country	Name	City	State
Spain	Faculty of Odontology, University Complutense	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (23)

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Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2. Review. — View Citation

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Moran F, Leonard T, Hawthorne S, Hughes CM, McCrum-Gardner E, Johnson MI, Rakel BA, Sluka KA, Walsh DM. Hypoalgesia in response to transcutaneous electrical nerve stimulation (TENS) depends on stimulation intensity. J Pain. 2011 Aug;12(8):929-35. doi: 10.1016/j.jpain.2011.02.352. Epub 2011 Apr 9. — View Citation

Nagai I, Tanaka N, Noguchi M, Suda Y, Sonoda T, Kohama G. Changes in occlusal state of patients with mandibular prognathism after orthognathic surgery: a pilot study. Br J Oral Maxillofac Surg. 2001 Dec;39(6):429-33. — View Citation

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Ohkura K, Harada K, Morishima S, Enomoto S. Changes in bite force and occlusal contact area after orthognathic surgery for correction of mandibular prognathism. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Feb;91(2):141-5. — View Citation

Oliveira Sierra S, Melo Deana A, Mesquita Ferrari RA, Maia Albarello P, Bussadori SK, Santos Fernandes KP. Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial. Trials. 2013 Nov 6;14:373. doi: 10.1186/1745-6215-14-373. — View Citation

Sato KL, Sanada LS, Rakel BA, Sluka KA. Increasing intensity of TENS prevents analgesic tolerance in rats. J Pain. 2012 Sep;13(9):884-90. doi: 10.1016/j.jpain.2012.06.004. Epub 2012 Aug 1. — View Citation

Teng TT, Ko EW, Huang CS, Chen YR. The Effect of early physiotherapy on the recovery of mandibular function after orthognathic surgery for Class III correction: part I--jaw-motion analysis. J Craniomaxillofac Surg. 2015 Jan;43(1):131-7. doi: 10.1016/j.jcms.2014.10.025. Epub 2014 Nov 1. — View Citation

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Tong KC, Lo SK, Cheing GL. Alternating frequencies of transcutaneous electric nerve stimulation: does it produce greater analgesic effects on mechanical and thermal pain thresholds? Arch Phys Med Rehabil. 2007 Oct;88(10):1344-9. — View Citation

Trawitzki LV, Silva JB, Regalo SC, Mello-Filho FV. Effect of class II and class III dentofacial deformities under orthodontic treatment on maximal isometric bite force. Arch Oral Biol. 2011 Oct;56(10):972-6. doi: 10.1016/j.archoralbio.2011.02.018. Epub 2011 Mar 25. — View Citation

Ueki K, Marukawa K, Hashiba Y, Nakagawa K, Degerliyurt K, Yamamoto E. Assessment of the relationship between the recovery of maximum mandibular opening and the maxillomandibular fixation period after orthognathic surgery. J Oral Maxillofac Surg. 2008 Mar;66(3):486-91. doi: 10.1016/j.joms.2007.08.044. — View Citation

Wen-Ching Ko E, Huang CS, Lo LJ, Chen YR. Longitudinal observation of mandibular motion pattern in patients with skeletal Class III malocclusion subsequent to orthognathic surgery. J Oral Maxillofac Surg. 2012 Feb;70(2):e158-68. doi: 10.1016/j.joms.2011.10.002. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bite force	Bite force will be measured using Dental Prescale Fuji® film placed between the occlusal surfaces of the two arches, and the patient will be asked to bite as strongly as possible for 5 sec and the best-defined tooth print will be photographed with a Canon® EOS 500 camera (RAW format, F32, and annular Flash) at the minimum distance permitted by the 75-macro lens. The image will be processed in a Mac computer to obtain the color value according to the Cie L*a*b* (CIELAB) scale, which gives the color a numerical value.The corresponding pressure units (Megapascals, MPa) will be calculated according to Dental Prescale specifications, and the bite force (in Newtons [N]) will be obtained by using the following formula: Bite Force= Bite Pressure (MPa) x mm2 print surface.	Measurements will be taken baseline (before surgery)
Primary	Bite force	Bite force will be measured using Dental Prescale Fuji® film placed between the occlusal surfaces of the two arches, and the patient will be asked to bite as strongly as possible for 5 sec and the best-defined tooth print will be photographed with a Canon® EOS 500 camera (RAW format, F32, and annular Flash) at the minimum distance permitted by the 75-macro lens. The image will be processed in a Mac computer to obtain the color value according to the Cie L*a*b* (CIELAB) scale, which gives the color a numerical value.The corresponding pressure units (Megapascals, MPa) will be calculated according to Dental Prescale specifications, and the bite force (in Newtons [N]) will be obtained by using the following formula: Bite Force= Bite Pressure (MPa) x mm2 print surface.	Measurements will be taken at 7 days after surgery
Primary	Bite force	Bite force will be measured using Dental Prescale Fuji® film placed between the occlusal surfaces of the two arches, and the patient will be asked to bite as strongly as possible for 5 sec and the best-defined tooth print will be photographed with a Canon® EOS 500 camera (RAW format, F32, and annular Flash) at the minimum distance permitted by the 75-macro lens. The image will be processed in a Mac computer to obtain the color value according to the Cie L*a*b* (CIELAB) scale, which gives the color a numerical value.The corresponding pressure units (Megapascals, MPa) will be calculated according to Dental Prescale specifications, and the bite force (in Newtons [N]) will be obtained by using the following formula: Bite Force= Bite Pressure (MPa) x mm2 print surface.	Measurements will be taken at 14 days after surgery
Primary	Bite force	Bite force will be measured using Dental Prescale Fuji® film placed between the occlusal surfaces of the two arches, and the patient will be asked to bite as strongly as possible for 5 sec and the best-defined tooth print will be photographed with a Canon® EOS 500 camera (RAW format, F32, and annular Flash) at the minimum distance permitted by the 75-macro lens. The image will be processed in a Mac computer to obtain the color value according to the Cie L*a*b* (CIELAB) scale, which gives the color a numerical value.The corresponding pressure units (Megapascals, MPa) will be calculated according to Dental Prescale specifications, and the bite force (in Newtons [N]) will be obtained by using the following formula: Bite Force= Bite Pressure (MPa) x mm2 print surface.	Measurements will be taken at 21 days after surgery
Primary	Bite force	Bite force will be measured using Dental Prescale Fuji® film placed between the occlusal surfaces of the two arches, and the patient will be asked to bite as strongly as possible for 5 sec and the best-defined tooth print will be photographed with a Canon® EOS 500 camera (RAW format, F32, and annular Flash) at the minimum distance permitted by the 75-macro lens. The image will be processed in a Mac computer to obtain the color value according to the Cie L*a*b* (CIELAB) scale, which gives the color a numerical value.The corresponding pressure units (Megapascals, MPa) will be calculated according to Dental Prescale specifications, and the bite force (in Newtons [N]) will be obtained by using the following formula: Bite Force= Bite Pressure (MPa) x mm2 print surface.	Measurements will be taken at 28 days after surgery
Primary	Jaw opening	Jaw opening will be evaluated with patients seated vertically upright in the dental chair, using a digital dental caliber (Model R 100110, Mestra®) to measure the maximum opening from the incisal margin of upper central incisors to the incisal margin of lower incisors, adding the amount (in mm) of overbite or subtracting the amount (in mm) of open bite in occlusion.	Measurements will be taken baseline (before surgery)
Primary	Jaw opening	Jaw opening will be evaluated with patients seated vertically upright in the dental chair, using a digital dental caliber (Model R 100110, Mestra®) to measure the maximum opening from the incisal margin of upper central incisors to the incisal margin of lower incisors, adding the amount (in mm) of overbite or subtracting the amount (in mm) of open bite in occlusion.	Measurements will be taken at 7 days after surgery
Primary	Jaw opening	Jaw opening will be evaluated with patients seated vertically upright in the dental chair, using a digital dental caliber (Model R 100110, Mestra®) to measure the maximum opening from the incisal margin of upper central incisors to the incisal margin of lower incisors, adding the amount (in mm) of overbite or subtracting the amount (in mm) of open bite in occlusion.	Measurements will be taken at 14 days after surgery
Primary	Jaw opening	Jaw opening will be evaluated with patients seated vertically upright in the dental chair, using a digital dental caliber (Model R 100110, Mestra®) to measure the maximum opening from the incisal margin of upper central incisors to the incisal margin of lower incisors, adding the amount (in mm) of overbite or subtracting the amount (in mm) of open bite in occlusion.	Measurements will be taken at 21 days after surgery
Primary	Jaw opening	Jaw opening will be evaluated with patients seated vertically upright in the dental chair, using a digital dental caliber (Model R 100110, Mestra®) to measure the maximum opening from the incisal margin of upper central incisors to the incisal margin of lower incisors, adding the amount (in mm) of overbite or subtracting the amount (in mm) of open bite in occlusion.	Measurements will be taken at 28 days after surgery
Primary	Pain (VAS)	Pain perceived by patients while autonomously opening and closing their jaws will be evaluated using a visual analog scale (VAS) from 0 (least pain value) to 10 (value of greater pain).	Measurements will be taken baseline (before surgery)
Primary	Pain (VAS)	Pain perceived by patients while autonomously opening and closing their jaws will be evaluated using a visual analog scale (VAS) from 0 (least pain value) to 10 (value of greater pain).	Measurements will be taken at 7 days after surgery
Primary	Pain (VAS)	Pain perceived by patients while autonomously opening and closing their jaws will be evaluated using a visual analog scale (VAS) from 0 (least pain value) to 10 (value of greater pain).	Measurements will be taken at 14 days after surgery
Primary	Pain (VAS)	Pain perceived by patients while autonomously opening and closing their jaws will be evaluated using a visual analog scale (VAS) from 0 (least pain value) to 10 (value of greater pain).	Measurements will be taken at 21 days after surgery
Primary	Pain (VAS)	Pain perceived by patients while autonomously opening and closing their jaws will be evaluated using a visual analog scale (VAS) from 0 (least pain value) to 10 (value of greater pain).	Measurements will be taken at 28 days after surgery
Primary	Inflammation	Inflammation will be measured (in mm) with patients seated upright in the dental chair, using a soft ruler to obtain a horizontal measurement from the lower border of the earlobe to the corner of the mouth and a vertical measurement from the gonial angle to the outer canthus of the eye. The soft ruler will be adapted to the contour of the patient's face without exerting any pressure.	Measurements will be taken baseline (before surgery)
Primary	Inflammation	Inflammation will be measured (in mm) with patients seated upright in the dental chair, using a soft ruler to obtain a horizontal measurement from the lower border of the earlobe to the corner of the mouth and a vertical measurement from the gonial angle to the outer canthus of the eye. The soft ruler will be adapted to the contour of the patient's face without exerting any pressure.	Measurements will be taken at 7 days after surgery
Primary	Inflammation	Inflammation will be measured (in mm) with patients seated upright in the dental chair, using a soft ruler to obtain a horizontal measurement from the lower border of the earlobe to the corner of the mouth and a vertical measurement from the gonial angle to the outer canthus of the eye. The soft ruler will be adapted to the contour of the patient's face without exerting any pressure.	Measurements will be taken at 14 days after surgery
Primary	Inflammation	Inflammation will be measured (in mm) with patients seated upright in the dental chair, using a soft ruler to obtain a horizontal measurement from the lower border of the earlobe to the corner of the mouth and a vertical measurement from the gonial angle to the outer canthus of the eye. The soft ruler will be adapted to the contour of the patient's face without exerting any pressure.	Measurements will be taken at 21 days after surgery
Primary	Inflammation	Inflammation will be measured (in mm) with patients seated upright in the dental chair, using a soft ruler to obtain a horizontal measurement from the lower border of the earlobe to the corner of the mouth and a vertical measurement from the gonial angle to the outer canthus of the eye. The soft ruler will be adapted to the contour of the patient's face without exerting any pressure.	Measurements will be taken at 28 days after surgery