Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 2:46 AM
Ignite Modification Date: 2025-12-25 @ 2:46 AM
NCT ID: NCT03465033
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.
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: NCT03465033
Study Brief:
Protocol Section: NCT03465033