Orthognathic SurgeryNCT05362383

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

A study testing transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model in people with Orthognathic Surgery and Physiology, run by Universidad Complutense de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 65 years
Conditions the study is for: Orthognathic Surgery, Physiology, Transcutaneous Electric Nerve Stimulation
What is being tested?: transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteSpain
Study dates: 1 Feb 2013to 15 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

impossibility to attend follow-up appointments
refusal of informed consent

Trial locations and contacts

1 site in 1 country.

Spain1 site

Faculty of Odontology, University Complutense
Madrid, 28040

Other trials in Spain

About this study

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

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

Read the 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
Being tested: transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model
Keywords: oral function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05362383
Study group	Role	What they receive
Experimental group	Experimental	transcutaneous electrical nerve stimulation (TENS) is applied Receives: Device: transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model
Control group	No intervention	no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measurements will be taken at 28 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201315 Jan 2020

First posted5 May 2022
Study start1 Feb 2013
Primary completion18 May 2018
Study completion15 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05362383
Sponsor's protocol ID: C.P. - C.I. 12/136-E
Status last verified: May 2022
First submitted: 24 Apr 2022
Last updated: 11 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25439086
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.
PubMed 22260918
Jung HD, Jung YS, Park JH, Park HS. Recovery pattern of mandibular movement by active physical therapy after bilateral transoral vertical ramus osteotomy. J Oral Maxillofac Surg. 2012 Jul;70(7):e431-7. doi: 10.1016/j.joms.2012.02.033.
PubMed 22698299
Bell WH, Gonyea W, Finn RA, Storum KA, Johnston C, Throckmorton GS. Muscular rehabilitation after orthognathic surgery. Oral Surg Oral Med Oral Pathol. 1983 Sep;56(3):229-35. doi: 10.1016/0030-4220(83)90001-4.
PubMed 6579456
Oh DW, Kim KS, Lee GW. The effect of physiotherapy on post-temporomandibular joint surgery patients. J Oral Rehabil. 2002 May;29(5):441-6. doi: 10.1046/j.1365-2842.2002.00850.x.
PubMed 12028491
Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
PubMed 23900134
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.
PubMed 22858165
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.
PubMed 19370680
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. doi: 10.1016/j.apmr.2007.07.017.
PubMed 17908580
Liebano RE, Rakel B, Vance CGT, Walsh DM, Sluka KA. An investigation of the development of analgesic tolerance to TENS in humans. Pain. 2011 Feb;152(2):335-342. doi: 10.1016/j.pain.2010.10.040. Epub 2010 Dec 8.
PubMed 21144659
Mendell LM. Constructing and deconstructing the gate theory of pain. Pain. 2014 Feb;155(2):210-216. doi: 10.1016/j.pain.2013.12.010. Epub 2013 Dec 12.
PubMed 24334188
Iwase M, Ohashi M, Tachibana H, Toyoshima T, Nagumo M. Bite force, occlusal contact area and masticatory efficiency before and after orthognathic surgical correction of mandibular prognathism. Int J Oral Maxillofac Surg. 2006 Dec;35(12):1102-7. doi: 10.1016/j.ijom.2006.08.014. Epub 2006 Nov 9.
PubMed 17097270
Hidaka O, Iwasaki M, Saito M, Morimoto T. Influence of clenching intensity on bite force balance, occlusal contact area, and average bite pressure. J Dent Res. 1999 Jul;78(7):1336-44. doi: 10.1177/00220345990780070801.
PubMed 10403461
Matsui Y, Ohno K, Michi K, Suzuki Y, Yamagata K. A computerized method for evaluating balance of occlusal load. J Oral Rehabil. 1996 Aug;23(8):530-5. doi: 10.1111/j.1365-2842.1996.tb00891.x.
PubMed 8866265
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. doi: 10.1067/moe.2001.112334.
PubMed 11174588

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Transcutaneous Electrical Nerve Stimulation (TENS) for the Recovery of Oral Function After Orthognathic Surgery
ClinicalTrials.gov ID: NCT05362383
Acronym / sponsor ID: C.P. - C.I. 12/136-E
Conditions: Orthognathic Surgery, Physiology, Transcutaneous Electric Nerve Stimulation
Keywords: oral function
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Universidad Complutense de MadridUniversity, hospital or other
Study start: 1 Feb 2013 (actual)
Primary completion: 18 May 2018 (actual)
Study completion: 15 Jan 2020 (actual)
First posted: 5 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Device: transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 modeltranscutaneous electrical nerve stimulation (TENS) is applied
Control group	No intervention	–no intervention

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

impossibility to attend follow-up appointments
refusal of informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 modelWill 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	Device	Experimental group

Primary outcome

Bite force
Time frame: Measurements will be taken baseline (before surgery)
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.
Bite force
Time frame: Measurements will be taken at 7 days after surgery
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.
Bite force
Time frame: Measurements will be taken at 14 days after surgery
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.
Bite force
Time frame: Measurements will be taken at 21 days after surgery
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.
Bite force
Time frame: Measurements will be taken at 28 days after surgery
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.
Jaw opening
Time frame: Measurements will be taken baseline (before surgery)
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.
Jaw opening
Time frame: Measurements will be taken at 7 days after surgery
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.
Jaw opening
Time frame: Measurements will be taken at 14 days after surgery
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.
Jaw opening
Time frame: Measurements will be taken at 21 days after surgery
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.
Jaw opening
Time frame: Measurements will be taken at 28 days after surgery
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.
Pain (VAS)
Time frame: Measurements will be taken baseline (before surgery)
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).
Pain (VAS)
Time frame: Measurements will be taken at 7 days after surgery
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).
Pain (VAS)
Time frame: Measurements will be taken at 14 days after surgery
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).
Pain (VAS)
Time frame: Measurements will be taken at 21 days after surgery
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).
Pain (VAS)
Time frame: Measurements will be taken at 28 days after surgery
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).
Inflammation
Time frame: Measurements will be taken baseline (before surgery)
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.
Inflammation
Time frame: Measurements will be taken at 7 days after surgery
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.
Inflammation
Time frame: Measurements will be taken at 14 days after surgery
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.
Inflammation
Time frame: Measurements will be taken at 21 days after surgery
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.
Inflammation
Time frame: Measurements will be taken at 28 days after surgery
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Background: PubMed 25439086Teng 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.
Background: PubMed 22260918Wen-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.
Background: PubMed 22698299Jung HD, Jung YS, Park JH, Park HS. Recovery pattern of mandibular movement by active physical therapy after bilateral transoral vertical ramus osteotomy. J Oral Maxillofac Surg. 2012 Jul;70(7):e431-7. doi: 10.1016/j.joms.2012.02.033.
Background: PubMed 6579456Bell WH, Gonyea W, Finn RA, Storum KA, Johnston C, Throckmorton GS. Muscular rehabilitation after orthognathic surgery. Oral Surg Oral Med Oral Pathol. 1983 Sep;56(3):229-35. doi: 10.1016/0030-4220(83)90001-4.
Background: PubMed 12028491Oh DW, Kim KS, Lee GW. The effect of physiotherapy on post-temporomandibular joint surgery patients. J Oral Rehabil. 2002 May;29(5):441-6. doi: 10.1046/j.1365-2842.2002.00850.x.
Background: PubMed 23900134Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
Background: PubMed 22858165Sato 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.
Background: PubMed 19370680Dowswell 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.
Background: PubMed 17908580Tong 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. doi: 10.1016/j.apmr.2007.07.017.
Background: PubMed 21144659Liebano RE, Rakel B, Vance CGT, Walsh DM, Sluka KA. An investigation of the development of analgesic tolerance to TENS in humans. Pain. 2011 Feb;152(2):335-342. doi: 10.1016/j.pain.2010.10.040. Epub 2010 Dec 8.
Background: PubMed 24334188Mendell LM. Constructing and deconstructing the gate theory of pain. Pain. 2014 Feb;155(2):210-216. doi: 10.1016/j.pain.2013.12.010. Epub 2013 Dec 12.
Background: PubMed 17097270Iwase M, Ohashi M, Tachibana H, Toyoshima T, Nagumo M. Bite force, occlusal contact area and masticatory efficiency before and after orthognathic surgical correction of mandibular prognathism. Int J Oral Maxillofac Surg. 2006 Dec;35(12):1102-7. doi: 10.1016/j.ijom.2006.08.014. Epub 2006 Nov 9.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alberto C Cacho, Prof principal investigator

Faculty of Odontology, University Complutense, Madrid

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bite force (time frame: Measurements will be taken baseline (before surgery)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05362383, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.