Orthognathic SurgeryNCT06103422
Change in Taste Sensation After Orthognathic Surgery
A study testing Whole mouth taste tests and Localized taste tests in people with Orthognathic Surgery and Altered Taste, run by Yağmur Malkoc at 2 sites in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 17 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgery, Altered Taste
- What is being tested?
- Whole mouth taste tests and Localized taste tests
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 17 Jul 2020to 25 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 42 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- dentofacial deformity
- American Society of Anesthesiologists category 1 or 2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Medipol University
Istanbul, Bağcılar, Istanbul, 34214
Istanbul Medipol University
Istanbul, Fatih, 34083
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthognathic Surgery, Altered Taste
- Being tested
- Whole mouth taste tests, Localized taste tests
- Keywords
- Gustation; Taste sense
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Localized taste testsDiagnostic test
Also called Spatial taste 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Whole mouth taste tests; Diagnostic 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. Receives: Diagnostic Test: Whole mouth taste tests; Diagnostic Test: Localized taste tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start17 Jul 2020
- Primary completion22 Jan 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yağmur Malkoc
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Responsible party
- Sponsor-investigator, Yağmur Malkoc, Istanbul Medipol University Hospital
- Investigators
- Sina UÇKAN, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103422
- Sponsor's protocol ID
- IstanbulMUH-DF-YM-01
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26935213Gent 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.
PubMed 12856248Al-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.
PubMed 8833294Ylikontiola 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.
PubMed 11078134Malkoc 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.
PubMed 38558265
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Change in Taste Sense After Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT06103422
- Acronym / sponsor ID
- IstanbulMUH-DF-YM-01
- Conditions
- Orthognathic Surgery, Altered Taste
- Keywords
- Gustation; Taste sense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Yağmur MalkocUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Streaming of patients and administration of tests | Experimental | Diagnostic Test: Whole mouth taste tests, Diagnostic Test: Localized taste tests35 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. |
| Repetition of tests at certain intervals | Experimental | Diagnostic Test: Whole mouth taste tests, Diagnostic Test: Localized taste testsGustatory functions were evaluated by administering localized taste tests and whole mouth taste tests preoperatively and at postoperative 1st, 3rd, and 6th months. |
Who may qualify
- Ages
- 17 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- dentofacial deformity
- American Society of Anesthesiologists category 1 or 2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole mouth taste testsPatients 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 | Repetition of tests at certain intervals, Streaming of patients and administration of tests |
| Localized taste testsAlso: Spatial taste testPatients 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. | Diagnostic test | Repetition of tests at certain intervals, Streaming of patients and administration of tests |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 26935213Bowe 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.
- Background: PubMed 12856248Gent 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.
- Background: PubMed 8833294Al-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.
- Background: PubMed 11078134Ylikontiola 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.
- Derived from this study: PubMed 38558265Malkoc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sina UÇKAN study director
Medipol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole mouth taste tests and Localized taste tests in people with Orthognathic Surgery and Altered Taste, run by Yağmur Malkoc at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste recognition threshold (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103422, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.