Effects of Orthognathic Surgery on Root Resorption and Soft Tissues

Not Applicable

Active, not recruiting

• Conditions: Orthodontics; Orthognathic Surgical Procedures

• Registration Number: NCT06873451
• Lead Sponsor: Gokhan Coban

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.

Study Timeline

• Study Start: 2023-08-15
• Study First Submitted: 2025-02-13
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-06-15
• Study Completion: 2025-08-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tooth length measurement	up to 15 months	Evaluation of length measurements that change depending on treatment using tomography
Tooth volume measurement	up to 15 months	Evaluation of volume measurements that change depending on treatment using tomography

Secondary Outcome Measures

Name	Time	Method
Soft tissue measurement	up to 15 months	Investigation of the effects of surgery on facial soft tissues with the stereophotogrammetry method

Trial Locations

Locations (1)

Erciyes University Faculty of Dentistry Department of Orthodontics; 🇹🇷 Kayseri, Melikgazi, Turkey