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Early Physiotherapy, Mandibular Motion and Sensorial Recovery After Orthognathic Surgery

U

University of the Basque Country (UPV/EHU)

Status

Unknown

Conditions

Mandibular Range of Motion
Sensorial Disturbance
Pain

Treatments

Other: Early Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03465033
M10_2017_194

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

Usual Care
No Intervention group
Description:
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 group
Treatment:
Other: Early Physiotherapy

Trial contacts and locations

1

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Central trial contact

Rafael Martinez-Conde, MD; Joana Laña, BS

Data sourced from clinicaltrials.gov

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