Mandibular Range of MotionNCT03465033
Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery
A study testing Early Physiotherapy in people with Mandibular Range of Motion and Pain, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
Several studies describe that the maximum mandibular opening decreases 60% -70% immediately after orthognathic surgery (OS) and other variables, including laterotrusion, movement speed and facial mimic also decrease drastically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Range of Motion, Pain, Sensorial Disturbance
- What is being tested?
- Early Physiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2018to 12 Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- Patients treated with orthodontics and OS for correction of dentofacial deformities.
Who cannot join
- Patients diagnosed with temporomandibular disorders
- Patients diagnosed with orofacial pain
- Patients diagnosed with orofacial sensory alterations
- Patients not treated with orthodontics
- Patients and who need to undergo OS interventions for the treatment of Sleep Apnea-Hypopnea Syndrome
- Patients that present cleft palate
- Patients that present cleft lip
- Patients diagnosed with syndromes that affect the orofacial structures.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
Leioa, Biscay, 48940
Rafael Martínez-Conde, MD, 34+ 946 01 2924, otpmallr@ehu.eus
Joana Laña, BS, 34+ 946 01 2929, joana.lana@ehu.eus
About this study
Several studies describe that the maximum mandibular opening decreases 60% -70% immediately after orthognathic surgery (OS) and other variables, including laterotrusion, movement speed and facial mimic also decrease drastically. In addition, patients frequently experience temporary or permanent sensory orofacial disturbances ranging from 9% to 76% of cases.
It has been described that scheduled early physiotherapy reduces these complications.
Read the detailed description
Before the surgical intervention (T0) the maximum interincisal oral opening measurement, laterotrusion and maximum protrusion will be recorded by digital caliber. The overbite and the overjet, length of upper lip and lower facial third will be measured. The symmetry of the upper lip in a forced smile will be determined. The measurements made at T0 will be repeated at T1 (2 weeks after surgery), T2 (5 weeks after surgery), T3 (9 weeks after surgery), T4 (12 weeks after surgery), T5 (24 weeks after surgery) and T6 (after orthodontic removal).The level of pain during the measurements of the mandibular movements will be recorded in the Visual Analogue Scale, and the self-reported area of the orofacial sensory alterations by means of a diagram and the objective area by means of the sensory discrimination test of two points will be determined. In T4, the impact of the status of the function and oral structures on daily activities will be recorded through a self-pass questionnaire based on the Oral Index Daily Performance questionnaire (OIDP-sp). In the T6 the measurement of laterotrusion, protrusion and retrusion movements measured by Gysi Gothic arch will be performed.
- Conditions
- Mandibular Range of Motion, Pain, Sensorial Disturbance
- Being tested
- Early Physiotherapy
- Keywords
- Orthognathic surgery, Jaw rehabilitation, Jaw Physiotherapy, Pain, Mandibular range of motion, Sensorial disturbance
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early PhysiotherapyOther
From T1 to T2 patients will perform 3 daily repetitions of active exercises:1 5 repetitions of oral opening exercises and bilateral manual progressive stretching, protrusion and maximum lateralization of the jaw on both sides, holding each movement for 5s and a session of cryotherapy applied to the masseter, temporal and suprahyoid muscles for 120s in two 60s sessions. They will also perform 30 repetitions of exercises aimed at improving the labial seal (inflate cheeks) and the symmetry of the upper lip (broad smile). From T2 to T3 30 repetitions of the same exercises will be performed and passive progressive opening will be implemented by "clamping" Patients will also perform isometric contraction exercises in opening, closing, laterotrusion, protrusion and retrusion. Each movement will be repeated 5 times and it will remain for 5s.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients will receive basic indications of rehabilitation consisting of daily mobilization of the jaw (perform several movements a day opening movements, laterotrusion and mouth protrusion). |
| Early Physiotherapy | Experimental | Not described Receives: Other: Early Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during mandibular movements
The level of pain during the measurements of the mandibular movements will be registered using a Visual Analogue Scale, in which point 0 represents "no pain" and point 10 "maximum pain". Values under point 5 are considered to represent mild pain and values above point 5 severe pain
Measured: week 12 (T4)
Maximum interincisor opening
The maximum interincisal oral opening measurement will be recorded by digital caliber
Measured: week 12 (T4)
Secondary outcomes (6)
Lip symmetry
Lip symmetry will be recorded by facial photography of the patient in broad smile
Measured: Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6)
Orofacial sensitivity
Self-reported area of orofacial sensory alterations will be measured by means of a diagram and the objective area by means of the sensory discrimination test of two points.
Measured: Week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6)
Laterotrusion
The oral laterotrusion measurement will be recorded by digital caliber
Measured: Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6)
Protrusion
The oral protrusion measurement will be recorded by digital caliber
Measured: Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6)
Impact of the status of the oral function and structures on daily activities
The impact of the status of the oral function and structures on daily activities will be recorded through a self-pass questionnaire based on the Oral Index Daily Performance questionnaire (OIDP-sp)). In the OIDP index impacts are quantified by multiplying the frequency and severity scores to obtain the performance score for each of eight dimensions (eating, speaking, cleaning teeth, working, social relation, sleeping/relaxing, smiling and emotional status). The sum of these scores is considered the total impact score. This total score is divided by the maximum possible score and multiplied by 100 to give the percentage score. This scoring system yields an intuitive oral impact score.
Measured: Week 12 (T4)
Functional oral movements - Gysi Gothic arch
The measurement of laterotrusion, protrusion and retrusion movements measured by Gysi Gothic arch will be performed and the functional oral movements capacity will be measured bay the total of millimeters of all movements
Measured: After orthodontic removal: up to one year after OS (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start30 Mar 2018 (estimated)
- Primary completion9 Mar 2020 (estimated)
- Study completion12 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mandibular Range of MotionStudies of the same condition, open and under way.
- 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
- Model description
- Patients undergoing OS will be studied. All patients will be told that two interventions are compared but they will not know which one is the usual care or the early physiotherapy. All of them will receive instructions of basic care after surgery: use of intermaxillary elastics, soft diet during the first month and semi-soft during the second month. Patients will be asked to remove the intermaxillary elastics 30min before the measurements.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Martínez-Conde Llamosas, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465033
- Sponsor's protocol ID
- M10_2017_194
- Status last verified
- Mar 2018
- First submitted
- 11 Feb 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Altmann EB. Myofunctional therapy and orthognathic surgery. Int J Orofacial Myology. 1987 Nov;13(3):2-12. No abstract available.
PubMed 3479402Bell 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 6579456Bonine FL. Exercises to improve facial animation after orthognathic surgery. J Oral Maxillofac Surg. 1998 Feb;56(2):281. doi: 10.1016/s0278-2391(98)90898-9. No abstract available.
PubMed 9461161Dietrich EM, Griessinger N, Neukam FW, Schlittenbauer T. Consultation with a specialized pain clinic reduces pain after oral and maxillofacial surgery. J Craniomaxillofac Surg. 2017 Feb;45(2):281-289. doi: 10.1016/j.jcms.2016.12.009. Epub 2016 Dec 14.
PubMed 28057402Essick GK, Phillips C, Kim SH, Zuniga J. Sensory retraining following orthognathic surgery: effect on threshold measures of sensory function. J Oral Rehabil. 2009 Jun;36(6):415-26. doi: 10.1111/j.1365-2842.2009.01954.x. Epub 2009 Apr 28.
PubMed 19422435Gallerano G, Ruoppolo G, Silvestri A. Myofunctional and speech rehabilitation after orthodontic-surgical treatment of dento-maxillofacial dysgnathia. Prog Orthod. 2012 May;13(1):57-68. doi: 10.1016/j.pio.2011.08.002. Epub 2012 Jan 25.
PubMed 22583588Hong SO, Baek SH, Choi JY. Physical Therapy for Smile Improvement After Orthognathic Surgery. J Craniofac Surg. 2017 Mar;28(2):422-426. doi: 10.1097/SCS.0000000000003099.
PubMed 28114219Montero J, Bravo M, Albaladejo A. Validation of two complementary oral-health related quality of life indicators (OIDP and OSS 0-10 ) in two qualitatively distinct samples of the Spanish population. Health Qual Life Outcomes. 2008 Nov 18;6:101. doi: 10.1186/1477-7525-6-101.
PubMed 19019208Phillips C, Kim SH, Tucker M, Turvey TA. Sensory retraining: burden in daily life related to altered sensation after orthognathic surgery, a randomized clinical trial. Orthod Craniofac Res. 2010 Aug;13(3):169-78. doi: 10.1111/j.1601-6343.2010.01493.x.
PubMed 20618719Teng 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT03465033
- Acronym / sponsor ID
- M10_2017_194
- Conditions
- Mandibular Range of Motion, Pain, Sensorial Disturbance
- Keywords
- Orthognathic surgery, Jaw rehabilitation, Jaw Physiotherapy, Pain, Mandibular range of motion, Sensorial disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 30 Mar 2018 (estimated)
- Primary completion
- 9 Mar 2020 (estimated)
- Study completion
- 12 Mar 2021 (estimated)
- First posted
- 14 Mar 2018 (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.
Several studies describe that the maximum mandibular opening decreases 60% -70% immediately after orthognathic surgery (OS) and other variables, including laterotrusion, movement speed and facial mimic also decrease drastically. In addition, patients frequently experience temporary or permanent sensory orofacial disturbances ranging from 9% to 76% of cases.
It has been described that scheduled early physiotherapy reduces these complications.
Detailed description
Before the surgical intervention (T0) the maximum interincisal oral opening measurement, laterotrusion and maximum protrusion will be recorded by digital caliber. The overbite and the overjet, length of upper lip and lower facial third will be measured. The symmetry of the upper lip in a forced smile will be determined. The measurements made at T0 will be repeated at T1 (2 weeks after surgery), T2 (5 weeks after surgery), T3 (9 weeks after surgery), T4 (12 weeks after surgery), T5 (24 weeks after surgery) and T6 (after orthodontic removal).The level of pain during the measurements of the mandibular movements will be recorded in the Visual Analogue Scale, and the self-reported area of the orofacial sensory alterations by means of a diagram and the objective area by means of the sensory discrimination test of two points will be determined. In T4, the impact of the status of the function and oral structures on daily activities will be recorded through a self-pass questionnaire based on the Oral Index Daily Performance questionnaire (OIDP-sp). In the T6 the measurement of laterotrusion, protrusion and retrusion movements measured by Gysi Gothic arch will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients undergoing OS will be studied. All patients will be told that two interventions are compared but they will not know which one is the usual care or the early physiotherapy. All of them will receive instructions of basic care after surgery: use of intermaxillary elastics, soft diet during the first month and semi-soft during the second month. Patients will be asked to remove the intermaxillary elastics 30min before the measurements.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will receive basic indications of rehabilitation consisting of daily mobilization of the jaw (perform several movements a day opening movements, laterotrusion and mouth protrusion). |
| Early Physiotherapy | Experimental | Other: Early Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years
- Patients treated with orthodontics and OS for correction of dentofacial deformities.
Key exclusion criteria (8 listed)
- Patients diagnosed with temporomandibular disorders
- Patients diagnosed with orofacial pain
- Patients diagnosed with orofacial sensory alterations
- Patients not treated with orthodontics
- Patients and who need to undergo OS interventions for the treatment of Sleep Apnea-Hypopnea Syndrome
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 |
|---|---|---|
| Early PhysiotherapyFrom T1 to T2 patients will perform 3 daily repetitions of active exercises:1 5 repetitions of oral opening exercises and bilateral manual progressive stretching, protrusion and maximum lateralization of the jaw on both sides, holding each movement for 5s and a session of cryotherapy applied to the masseter, temporal and suprahyoid muscles for 120s in two 60s sessions. They will also perform 30 repetitions of exercises aimed at improving the labial seal (inflate cheeks) and the symmetry of the upper lip (broad smile). From T2 to T3 30 repetitions of the same exercises will be performed and passive progressive opening will be implemented by "clamping" Patients will also perform isometric contraction exercises in opening, closing, laterotrusion, protrusion and retrusion. Each movement will be repeated 5 times and it will remain for 5s. | Other | Early Physiotherapy |
Primary outcome
Pain during mandibular movements
Time frame: week 12 (T4)
The level of pain during the measurements of the mandibular movements will be registered using a Visual Analogue Scale, in which point 0 represents "no pain" and point 10 "maximum pain". Values under point 5 are considered to represent mild pain and values above point 5 severe pain
Maximum interincisor opening
Time frame: week 12 (T4)
The maximum interincisal oral opening measurement will be recorded by digital caliber
6 secondary outcomes
Lip symmetry
Time frame: Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6)
Orofacial sensitivity
Time frame: Week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6)
Laterotrusion
Time frame: Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6)
Protrusion
Time frame: Before OS (T0), week 2 after surgery (T1), week 5 (T2), week 9 (T3), week 12 (T4), week 24 (T5), and after orthodontic removal: up to one year after OS (T6)
Impact of the status of the oral function and structures on daily activities
Time frame: Week 12 (T4)
Functional oral movements - Gysi Gothic arch
Time frame: After orthodontic removal: up to one year after OS (T6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Background: PubMed 3479402Altmann EB. Myofunctional therapy and orthognathic surgery. Int J Orofacial Myology. 1987 Nov;13(3):2-12. No abstract available.
- 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 9461161Bonine FL. Exercises to improve facial animation after orthognathic surgery. J Oral Maxillofac Surg. 1998 Feb;56(2):281. doi: 10.1016/s0278-2391(98)90898-9. No abstract available.
- Background: PubMed 28057402Dietrich EM, Griessinger N, Neukam FW, Schlittenbauer T. Consultation with a specialized pain clinic reduces pain after oral and maxillofacial surgery. J Craniomaxillofac Surg. 2017 Feb;45(2):281-289. doi: 10.1016/j.jcms.2016.12.009. Epub 2016 Dec 14.
- Background: PubMed 19422435Essick GK, Phillips C, Kim SH, Zuniga J. Sensory retraining following orthognathic surgery: effect on threshold measures of sensory function. J Oral Rehabil. 2009 Jun;36(6):415-26. doi: 10.1111/j.1365-2842.2009.01954.x. Epub 2009 Apr 28.
- Background: PubMed 22583588Gallerano G, Ruoppolo G, Silvestri A. Myofunctional and speech rehabilitation after orthodontic-surgical treatment of dento-maxillofacial dysgnathia. Prog Orthod. 2012 May;13(1):57-68. doi: 10.1016/j.pio.2011.08.002. Epub 2012 Jan 25.
- Background: PubMed 28114219Hong SO, Baek SH, Choi JY. Physical Therapy for Smile Improvement After Orthognathic Surgery. J Craniofac Surg. 2017 Mar;28(2):422-426. doi: 10.1097/SCS.0000000000003099.
- Background: PubMed 19019208Montero J, Bravo M, Albaladejo A. Validation of two complementary oral-health related quality of life indicators (OIDP and OSS 0-10 ) in two qualitatively distinct samples of the Spanish population. Health Qual Life Outcomes. 2008 Nov 18;6:101. doi: 10.1186/1477-7525-6-101.
- Background: PubMed 20618719Phillips C, Kim SH, Tucker M, Turvey TA. Sensory retraining: burden in daily life related to altered sensation after orthognathic surgery, a randomized clinical trial. Orthod Craniofac Res. 2010 Aug;13(3):169-78. doi: 10.1111/j.1601-6343.2010.01493.x.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Physiotherapy in people with Mandibular Range of Motion and Pain, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael Martinez-Conde, MD (34+ 946 01 2924, otpmallr@ehu.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during mandibular movements (time frame: week 12 (T4)). The study lists 2 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 NCT03465033, which also lists 10 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 14 Mar 2018.