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Completed

NCT Number: NCT06873451

Effects of Orthognathic Surgery on Root Resorption and Soft Tissues

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.

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Key information

Conditions

Orthodontics Orthognathic Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry Department of Orthodontics

Kayseri, Melikgazi, 38000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surgery first

Procedure

One month after surgery, patients were called for an appointment and lower and upper brackets were placed. Treatment was completed when right-left Class I canine and molar relationships and ideal overjet and overbite relationships were achieved.

Surgery Early

Procedure

The patients were directed to surgery with the upper and lower bonds applied at their first appointment and the brackets in their mouths. After surgery, treatment continued until the right-left Class I canine and molar relationship and the ideal overjet and overbite relationship were achieved.

Primary outcomes

  1. Tooth length measurement (mm)

    Time frame: up to 15 months

    Root length of maxillary incisors will be measured using cone-beam computed tomography (CBCT). Data will be reported as mean change (± SD).

  2. Tooth volume measurement (mm^3)

    Time frame: up to 15 months

    Root volume of maxillary incisors will be measured using cone-beam computed tomography (CBCT). Data will be reported as mean change (± SD).

Secondary outcomes

  1. Soft tissue measurement (3D)

    Time frame: up to 15 months

    Three-dimensional stereophotogrammetry will be used to assess changes in facial soft tissue profile, including convexity and lip-chin relationships. Results will be summarized as mean changes (± SD).

Sponsors and collaborators

Lead sponsor

Gokhan Coban

Other

Collaborators

  • TC Erciyes University

Registry information

Official study title

3D Comparison Effects of Two Different Surgical Timings in Orthognathic Surgery on Root Resorption and Soft Tissues: Surgery First vs. Surgery Early

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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