Orthognathic Surgery Clinical Trial
Official title:
Evaluation of Change in Taste Sense After Orthognathic Surgery
Verified date | October 2023 |
Source | Istanbul Medipol University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | November 25, 2021 |
Est. primary completion date | January 22, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 42 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University | Istanbul | Bagcilar, Istanbul |
Turkey | Istanbul Medipol University | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Yagmur Malkoc | Istanbul Medipol University Hospital |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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