Change in Taste Sensation After Orthognathic Surgery

Orthognathic Surgery Clinical Trial

Official title:

Evaluation of Change in Taste Sense After Orthognathic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103422
• Other study ID #: IstanbulMUH-DF-YM-01
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: November 25, 2021

Study information

• Verified date: October 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Orthognathic surgery refers to jaw operations that can be performed on the upper jaws (Le Fort I osteotomy) and lower jaws (Sagittal Split Ramus osteotomy). In orthognathic surgery practice, taste perception could be affected by potential damage to peripheral nerves that conduct chemosensory information regarding gustation from the palate and tongue. This study aimed to evaluate the changes in the sense of taste after Le Fort I osteotomy, Sagittal Split Ramus osteotomy, and bimaxillary surgery.

Description:

The subjects were orthognathic surgery patients with facial skeletal deformities who applied to the Department of Oral and Maxillofacial Surgery. Thirty-five patients, aged 17-42 years, gustatory functions were evaluated by administering localized taste tests and whole mouth taste tests preoperatively and at postoperative 1st, 3rd, and 6th months. In the tests, solutions containing sucrose for a sweet taste, sodium chloride for a salty taste, citric acid for a sour taste, and quinine hydrochloride for a bitter taste were used. Patients were compared between the operation group they were in and between operation groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 25, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 42 Years

Eligibility

Inclusion Criteria:

• dentofacial deformity
• American Society of Anesthesiologists category 1 or 2

Exclusion Criteria:

• zinc, iron, and/or vitamin deficiencies
• oncological, neurological, endocrinological, and rheumatological diseases
• chronic drug use due to systemic disease
• smokers
• history of chemotherapy and radiotherapy to the head and neck region, orthognathic surgery, maxillofacial trauma, and damage to the nerves related to the taste sensation

Related Conditions & MeSH terms

• Dysgeusia
• Orthognathic Surgery

Intervention

Diagnostic Test:
• Whole mouth taste tests
Patients who underwent Le Fort I osteotomy, Sagittal Split Ramus Osteotomy, and Bimaxillary Surgeries were asked to identify the quality of 4 basic taste modalities preoperatively and at postoperative 1st, 3rd, and 6th months by administering whole mouth taste tests. In the whole mouth taste test, one ml of the specific solution was drawn into the syringe and sprayed into the mouth of the patient circularly. After each administration, patients spat out the solutions and reported whether they perceived any taste and, if so, which taste it was.
• Localized taste tests
Patients who underwent Le Fort I osteotomy, Sagittal Split Ramus Osteotomy, and Bimaxillary Surgeries were asked to identify the quality of 4 basic taste modalities preoperatively and at postoperative 1st, 3rd, and 6th months by administering localized taste tests. In the localized mouth taste test, the highest concentration solution of one of the four flavors was administered. In each application, 0.25 ml of solution was absorbed on a sterile cotton swab and applied on 6 test areas on the palate and tongue.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul	Bagcilar, Istanbul
Turkey	Istanbul Medipol University	Istanbul	Fatih

Sponsors (2)

Lead Sponsor	Collaborator
Yagmur Malkoc	Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Al-Din OF, Coghlan KM, Magennis P. Sensory nerve disturbance following Le Fort I osteotomy. Int J Oral Maxillofac Surg. 1996 Feb;25(1):13-9. doi: 10.1016/s0901-5027(96)80005-1. — View Citation

Bowe DC, Gruber EA, McLeod NM. Nerve injury associated with orthognathic surgery. Part 1: UK practice and motor nerve injuries. Br J Oral Maxillofac Surg. 2016 May;54(4):362-5. doi: 10.1016/j.bjoms.2016.01.026. Epub 2016 Feb 28. — View Citation

Gent JF, Shafer DM, Frank ME. The effect of orthognathic surgery on taste function on the palate and tongue. J Oral Maxillofac Surg. 2003 Jul;61(7):766-73. doi: 10.1016/s0278-2391(03)00152-6. — View Citation

Ylikontiola L, Kinnunen J, Oikarinen K. Factors affecting neurosensory disturbance after mandibular bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2000 Nov;58(11):1234-9; discussion 1239-40. doi: 10.1053/joms.2000.16621. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taste recognition threshold	The solutions were administered in increasing concentrations, starting from the lowest concentration up to the highest concentration until the patient perceived any taste. The lowest concentration at which the patient correctly perceived the administered taste was defined as the "taste recognition threshold. Taste recognition threshold is the primer outcome for whole-mouth taste tests.	Six months
Primary	Taste intensity rating	The patients were instructed to focus on the perceived taste without closing their mouths and asked to identify the taste and rate the intensity of the taste using a scale ranging between 0 'no taste' and 9 'strongest taste', after each administration. Taste intensity rating is the primer outcome for localized taste tests.	Six months