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

NCT05362383 | Completed

• 1 other identifier: C.P. - C.I. 12/136-E
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Orthognathic Surgery; Physiology; Transcutaneous Electric Nerve Stimulation

Keywords

oral function

Outcome Measures

Primary Outcomes (20)

• 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)

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

transcutaneous electrical nerve stimulation (TENS) is applied

Device: transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model

Control group

NO INTERVENTION

no intervention

Interventions

transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model DEVICE

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

Experimental group

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Faculty of Odontology, University Complutense

Madrid, 28040, Spain

Location

Related Publications (23)

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MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Alberto C Cacho, Prof

  Faculty of Odontology, University Complutense, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Department Chair, Department of Dental Clinical Specialties, Faculty of Odontology, Complutense University, Madrid, Spain

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 5, 2022
• Study Start: February 1, 2013
• Primary Completion: May 18, 2018
• Study Completion: January 15, 2020
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)