Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery

NCT03465033 | Unknown DMC

• 1 other identifier: M10_2017_194
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mandibular Range of Motion; Pain; Sensorial Disturbance

Keywords

Orthognathic surgery; Jaw rehabilitation; Jaw Physiotherapy; Pain; Mandibular range of motion; Sensorial disturbance

Outcome Measures

Primary Outcomes (2)

• 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

  week 12 (T4)

• Maximum interincisor opening

  The maximum interincisal oral opening measurement will be recorded by digital caliber

  week 12 (T4)

Secondary Outcomes (6)

• Lip symmetry

  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

  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

  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

  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

  Week 12 (T4)

Study Arms (2)

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

Interventions

Early Physiotherapy 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.

Early Physiotherapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

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

Leioa, Biscay, 48940, Spain

RECRUITING

Related Publications (10)

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

  PMID: 3479402 BACKGROUND

• 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.

  PMID: 6579456 BACKGROUND

• 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.

  PMID: 9461161 BACKGROUND

• 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.

  PMID: 28057402 BACKGROUND

• 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.

  PMID: 19422435 BACKGROUND

• 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.

  PMID: 22583588 BACKGROUND

• 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.

  PMID: 28114219 BACKGROUND

• 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.

  PMID: 19019208 BACKGROUND

• 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.

  PMID: 20618719 BACKGROUND

• 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.

  PMID: 25439086 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rafael Martinez-Conde, MD

CONTACT

34+ 946 01 2924; otpmallr@ehu.eus

Joana Laña, BS

CONTACT

34+ 946 01 2929; joana.lana@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: March 14, 2018
• Study Start: March 30, 2018
• Primary Completion: March 9, 2020
• Study Completion: March 12, 2021
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

ES (1)