Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery

Pain Clinical Trial

Official title:

Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03465033
• Other study ID #: M10_2017_194
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2018
• Last updated: March 13, 2018
• Start date: March 30, 2018
• Est. completion date: March 12, 2021

Study information

• Verified date: March 2018
• Source: Basque Country University
• Contact: Rafael Martinez-Conde, MD
• Phone: 34+ 946 01 2924
• Email: otpmallr[@]ehu.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 12, 2021
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mandibular Range of Motion
• Pain
• Sensorial Disturbance

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country	Leioa	Biscay

Sponsors (1)

Lead Sponsor	Collaborator
Basque Country University

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Altmann EB. Myofunctional therapy and orthognathic surgery. Int J Orofacial Myology. 1987 Nov;13(3):2-12. — View Citation

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. — View Citation

Bonine FL. Exercises to improve facial animation after orthognathic surgery. J Oral Maxillofac Surg. 1998 Feb;56(2):281. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Maximum interincisor opening	The maximum interincisal oral opening measurement will be recorded by digital caliber	week 12 (T4)
Secondary	Lip symmetry	Lip symmetry will be recorded by facial photography of the patient in broad smile	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)
Secondary	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.	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)
Secondary	Laterotrusion	The oral laterotrusion measurement will be recorded by digital caliber	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)
Secondary	Protrusion	The oral protrusion measurement will be recorded by digital caliber	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)
Secondary	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.	Week 12 (T4)
Secondary	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	After orthodontic removal: up to one year after OS (T6)