NCT06103422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 23, 2023

Last Update Submit

October 23, 2023

Conditions

Orthognathic SurgeryAltered Taste

Keywords

Gustation; Taste sense

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Streaming of patients and administration of tests

EXPERIMENTAL

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 testsDiagnostic Test: Localized taste tests

Repetition of tests at certain intervals

EXPERIMENTAL

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 testsDiagnostic Test: Localized taste tests

Interventions

Whole mouth taste testsDIAGNOSTIC_TEST

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.

Repetition of tests at certain intervalsStreaming of patients and administration of tests
Localized taste testsDIAGNOSTIC_TEST

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
Repetition of tests at certain intervalsStreaming of patients and administration of tests

Eligibility Criteria

Age17 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Medipol University

Istanbul, Bağcılar, Istanbul, 34214, Turkey (Türkiye)

Location

Istanbul Medipol University

Istanbul, Fatih, 34083, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 26935213BACKGROUND

  • 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.

    PMID: 12856248BACKGROUND

  • 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.

    PMID: 8833294BACKGROUND

  • 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.

    PMID: 11078134BACKGROUND

  • Malkoc Y, Gulsever S, Uckan S. Change in taste sensation after orthognathic surgery. Clin Oral Investig. 2024 Apr 1;28(4):237. doi: 10.1007/s00784-024-05626-1.

    PMID: 38558265DERIVED

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sina UÇKAN

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DDS (Doctor of Dental Surgery)

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 26, 2023

Study Start

July 17, 2020

Primary Completion

January 22, 2021

Study Completion

November 25, 2021

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report Access
Individual Participant Data Set Access
Individual Participant Data Set Access

Locations

TU(2)