CompletedNot Applicable

Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume

Turkey (Türkiye)47 participantsStarted 2021-01-15

Plain-language summary

After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * aged 18-40, ASA I, without systemic disease, without any drug allergy, and without a history of NSAID use in the week before the operation. Exclusion Criteria: * ASA II or higher, hepatic or renal dysfunction, neuropathic disease, long-term use of NSAIDs or opioid-derived drugs, a history of allergic reaction to drugs, pain, swelling, inflammation in the head and neck region before the operation, pregnant and breastfeeding with a history of cleft lip and palate and rhinoplasty surgery

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of Septum Deviation

Timeframe: up to six months

Evaluation of Nasal Airway

Timeframe: up to six months

Trial details

NCT IDNCT06281197

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-15

View on ClinicalTrials.gov More Maxillofacial Abnormalities trials