Change in Taste Sensation After Orthognathic Surgery

Sponsor
Yağmur Malkoc (Other)
Overall Status
Completed
CT.gov ID
NCT06103422
Collaborator
Istanbul Medipol University Hospital (Other)
35
2
2
16.3
17.5
1.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Whole mouth taste tests
  • Diagnostic Test: Localized taste tests
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evaluation of Change in Taste Sense After Orthognathic Surgery
Actual Study Start Date :
Jul 17, 2020
Actual Primary Completion Date :
Jan 22, 2021
Actual Study Completion Date :
Nov 25, 2021

Arms and Interventions

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.

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.

Diagnostic Test: 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.
Other Names:
  • Spatial taste test
  • 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.

    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.

    Diagnostic Test: 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.
    Other Names:
  • Spatial taste test
  • Outcome Measures

    Primary Outcome Measures

    1. Taste recognition threshold [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.

    2. Taste intensity rating [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 42 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul Medipol University Istanbul Bağcılar, Istanbul Turkey 34214
    2 Istanbul Medipol University Istanbul Fatih Turkey 34083

    Sponsors and Collaborators

    • Yağmur Malkoc
    • Istanbul Medipol University Hospital

    Investigators

    • Study Director: Sina UÇKAN, Medipol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yağmur Malkoc, DDS (Doctor of Dental Surgery), Istanbul Medipol University Hospital
    ClinicalTrials.gov Identifier:
    NCT06103422
    Other Study ID Numbers:
    • IstanbulMUH-DF-YM-01
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yağmur Malkoc, DDS (Doctor of Dental Surgery), Istanbul Medipol University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2023