Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery

NCT ID: NCT03465033

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2021-03-12

Brief Summary

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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

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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

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Mandibular Range of Motion Pain Sensorial Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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. Professionals that will evaluate the measurements and the investigators that will make the statistical analysis, all will be blinded to treatment allocation.

Study Groups

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Usual Care

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Early Physiotherapy

Group Type EXPERIMENTAL

Early Physiotherapy

Intervention Type OTHER

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.

Interventions

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Early Physiotherapy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥18 years
* Patients treated with orthodontics and OS for correction of dentofacial deformities.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role lead

Responsible Party

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Rafael Martínez-Conde Llamosas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country

Leioa, Biscay, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rafael Martinez-Conde, MD

Role: CONTACT

34+ 946 01 2924

Joana Laña, BS

Role: CONTACT

34+ 946 01 2929

Facility Contacts

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Rafael Martínez-Conde, MD

Role: primary

34+ 946 01 2924

Joana Laña, BS

Role: backup

34+ 946 01 2929

References

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Altmann EB. Myofunctional therapy and orthognathic surgery. Int J Orofacial Myology. 1987 Nov;13(3):2-12. No abstract available.

Reference Type BACKGROUND
PMID: 3479402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6579456 (View on PubMed)

Bonine 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.

Reference Type BACKGROUND
PMID: 9461161 (View on PubMed)

Dietrich 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.

Reference Type BACKGROUND
PMID: 28057402 (View on PubMed)

Essick 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.

Reference Type BACKGROUND
PMID: 19422435 (View on PubMed)

Gallerano 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.

Reference Type BACKGROUND
PMID: 22583588 (View on PubMed)

Hong 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.

Reference Type BACKGROUND
PMID: 28114219 (View on PubMed)

Montero 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.

Reference Type BACKGROUND
PMID: 19019208 (View on PubMed)

Phillips 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.

Reference Type BACKGROUND
PMID: 20618719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25439086 (View on PubMed)

Other Identifiers

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M10_2017_194

Identifier Type: -

Identifier Source: org_study_id

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