An interventional study of Whole mouth taste tests and Localized taste tests in Orthognathic Surgery and Altered Taste, sponsored by Yağmur Malkoc. Completed at 2 sites in Turkey. Open to participants aged 17 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Yağmur Malkoc · Not applicable, Interventional, and Screening
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.
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.
52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.
This study's enrollment of 35 is below the median of 49 across 28 interventional studies indexed under Dysgeusia.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Diagnostic Test: Localized taste tests
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 · 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 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.
Also known as: Spatial taste test
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.
Time frame: Six months
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.
Time frame: Six months
Plan to share: No
Ran from Jul 2020 to primary completion in Jan 2021, 6 months.
Of 18 interventional studies with no phase under Dysgeusia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 16. This study's 6 months is below that.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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