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Clinical Trials in Turkey / NCT07349056
Recruiting Observational

Early Effects of Orthognathic Surgery on Periodontal Phenotype: A 6-Month Prospective Clinical and Radiographic Evaluation

NCT07349056 · tracked via the Priya Life Science Turkey tracker
Sponsor
Trakya University
Phase
Observational
Started
2026-02-23
Last updated
2026-06-08

Condition(s) studied

Gingival BiotypeGingival PhenotypeBuccal Bone ThicknessRecession, GingivalDental Surgery

Study summary

The goal of this observational study is to learn how the health and thickness of the gums and supporting bone around the teeth change over 6 months in adults having jaw surgery to correct the bite. The main questions it aims to answer are:

* Do gum and tooth-support measurements change from before surgery to 1, 3, and 6 months after surgery?
* Do CT scan-based measurements of the tooth-supporting bone change over the same time period?

Participants will:

* Have a gum check-up (periodontal examination) before surgery and at 1, 3, and 6 months after surgery.
* Have CT scan-based measurements (CBCT) taken at the same time points for study assessment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Adults aged ≥18 years. * Presence of a Class III molar relationship of any severity at baseline. * Presence of a Class II molar relationship of any severity at baseline. * Presence of transverse arch discrepancies. * Presence of vertical maxillary excess. * Presence of maxillary and/or mandibular asymmetry. * Presence of anterior open bite. * Full permanent dentition up to the first molars, with no supernumerary teeth and no agenesis (congenital absence) of teeth up to the first molars. * No previous orthodontic treatment. * No history of tooth extraction other than second or third molars. * Availability of complete baseline and end-of-follow-up periodontal parameters and phenotype records suitable for evaluation. * Healthy periodontium with no signs of gingival hypertrophy. * No systemic disease history or medication use that could affect gingival/periodontal conditions. Exclusion Criteria: * Patients planned for orthodontic camouflage treatment with fixed appliances for Class II/Class III correction instead of orthognathic surgery. * History of interproximal enamel reduction (interproximal stripping). * Presence of dental implants. * Age \< 18 years. * Pregnant or breastfeeding individuals. * Any systemic condition contraindicates orthognathic surgery. * Psychiatric disorders. * Syndromic conditions. * History of previous orthognathic surgery. * Refusal to sign the informed consent form. * Individuals belonging to a vulnerable population.

Primary outcome measure(s)

  • Change in width of keratinized gingiva (mm) — Baseline (preoperative) and postoperative 1, 3, and 6 months.
    Width of keratinized gingiva is measured as the distance from the gingival margin to the mucogingival junction, recorded in mm.
  • Change in gingival thickness phenotype (thin vs thick) — Baseline (preoperative) and postoperative 1, 3, and 6 months.
    Gingival thickness is assessed with a periodontal probe by the probe-transparency method and categorized as thin (≤1 mm; probe visible) or thick (\>1 mm; probe not visible)
  • Change in buccal cortical bone thickness on CBCT (mm) — Baseline (preoperative) and postoperative follow-up CBCT records were obtained during routine controls (planned at 6 months).
    Buccal cortical bone thickness is measured on CBCT as the horizontal distance from the deepest point of the buccal marginal bone curvature (A) to the CEJ, and additionally at 4 mm apical to A and at the apex level, as defined in the protocol

Trial sites (2)

FacilityCityRegionStatus
Trakya University Faculty of Dentistry Edirne Turkey (Türkiye) Recruiting
Kocaeli Health and Technology University Faculty of Dentistry Kocaeli Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07349056 on ClinicalTrials.gov ↗ ← All trials in Turkey