Clinical trial NCT06873451: Effects of Orthognathic Surgery on Root Resorption and Soft Tissues
Official title: 3D Comparison Effects of Two Different Surgical Timings in Orthognathic Surgery on Root Resorption and Soft Tissues: Surgery First vs. Surgery Early
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthodontics
Orthognathic Surgical Procedures
Keywords: Orthognathic surgery
Surgery first
surgery early
dehiscence
Fenestration
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2025-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the three-dimensional tomographic and photographic evaluation of the provision of two different orthognathic surgeries on hard and soft tissues with informative Class III deformity due to maxillary retrognathia and mandibular prognathia.

Detailed description: Patients who will undergo non-extraction surgery will be randomized as 'Pre-Surgery' (SEC) and 'Early Surgery' (EC). Maxillary advancement and mandibular recession will be calculated and a total of 24 patients, 12 in each group, will be included in the study. Millimetric (length, dehiscence, fenestration) and volumetric measurements and soft tissue anthropometric points will be measured in three-dimensional recordings taken at the beginning of treatment (T0) and after debonding (T1). Cone beam computed tomography (CBCT) images will be transferred to NNT and 'Mimics 18.0' programs for measurements. Three-dimensional photographs will be evaluated in the 3dMDvultus program. Shapiro-Wilk test will be used for normality, 'two independent samples t-test' and 'Mann Whitney U test' will be used for intra-group and inter-group comparisons.

Eligibility criteria: Inclusion Criteria:

* They must be over 18 years of age,
* Skeletal Class III malocclusion and need double jaw orthognathic surgery,
* Minimum crowding (patients with crowding between 0-3 mm),
* Complete 3D records before surgery and at the end of treatment,
* No decay on their teeth,
* Good oral hygiene,
* Healthy periodontal tissues.

Exclusion Criteria:

* History of trauma,
* Congenital anomalies or craniofacial deformities
* Congenital tooth loss (excluding wisdom teeth)

Primary outcomes:
measure: Tooth length measurement
timeFrame: up to 15 months
measure: Tooth volume measurement
timeFrame: up to 15 months
Secondary outcomes:
measure: Soft tissue measurement
timeFrame: up to 15 months
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Dentistry Department of Orthodontics
state: Melikgazi
Study officials:
References:
citation: Juggins KJ, Nixon F, Cunningham SJ. Patient- and clinician-perceived need for orthognathic surgery. Am J Orthod Dentofacial Orthop. 2005 Dec;128(6):697-702. doi: 10.1016/j.ajodo.2004.09.022.
citation: Hernandez-Alfaro F, Guijarro-Martinez R. On a definition of the appropriate timing for surgical intervention in orthognathic surgery. Int J Oral Maxillofac Surg. 2014 Jul;43(7):846-55. doi: 10.1016/j.ijom.2014.02.007. Epub 2014 Mar 13.
citation: Millesi GA, Zimmermann M, Eltz M. Surgery First and Surgery Early Treatment Approach in Orthognathic Surgery. Oral Maxillofac Surg Clin North Am. 2023 Feb;35(1):71-82. doi: 10.1016/j.coms.2022.06.010. Epub 2022 Nov 3.
citation: Hernandez-Alfaro F, Guijarro-Martinez R, Molina-Coral A, Badia-Escriche C. "Surgery first" in bimaxillary orthognathic surgery. J Oral Maxillofac Surg. 2011 Jun;69(6):e201-7. doi: 10.1016/j.joms.2011.01.010. Epub 2011 Apr 5. No abstract available.