- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06103422
Change in Taste Sensation After Orthognathic Surgery
October 23, 2023 updated by: Yağmur Malkoc
Evaluation of Change in Taste Sense After Orthognathic Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bağcılar, Istanbul
-
Istanbul, Bağcılar, Istanbul, Turkey, 34214
- Istanbul Medipol University
-
-
Fatih
-
Istanbul, Fatih, Turkey, 34083
- Istanbul Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Streaming of patients and administration of tests
35 patients who met the inclusion criteria were divided into surgical groups.
Patients with indications for upper jaw surgery were divided into Le Fort I operation, patients with lower jaw surgery were divided into Sagittal Split Ramus operation, and double jaw surgery groups.
Localized taste tests and whole-mouth taste tests were applied to the patients.
|
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.
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.
Other Names:
|
|
Experimental: Repetition of tests at certain intervals
Gustatory functions were evaluated by administering localized taste tests and whole mouth taste tests preoperatively and at postoperative 1st, 3rd, and 6th months.
|
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Taste recognition threshold
Time Frame: Six months
|
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
|
|
Taste intensity rating
Time Frame: Six months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Sina UÇKAN, Medipol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2020
Primary Completion (Actual)
January 22, 2021
Study Completion (Actual)
November 25, 2021
Study Registration Dates
First Submitted
October 23, 2023
First Submitted That Met QC Criteria
October 23, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 23, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMUH-DF-YM-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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