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NCT Number: NCT07349056

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya University Faculty of Dentistry, Edirne, Turkey (Türkiye)

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About this study

This two-center prospective observational cohort study will enroll adult patients who are scheduled to undergo orthognathic surgery according to standard clinical indications. Orthognathic surgeries will be performed at Kocaeli Health and Technology University, while periodontal clinical examinations and CBCT-based assessments will be conducted at Trakya University. Participants will be evaluated at baseline (preoperatively) and at 1, 3, and 6 months after surgery. Clinical periodontal assessments will include predefined periodontal phenotype-related parameters recorded using a standardized protocol. CBCT datasets will be obtained and analyzed using a standardized measurement protocol to assess buccal alveolar bone-related parameters and the presence of dehiscence/fenestration where applicable. To minimize assessment bias, CBCT images will be coded and evaluated by an independent assessor blinded to surgical details and group classification, and clinical periodontal examinations will be performed by an examiner blinded to the surgical procedure details.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Change in width of keratinized gingiva (mm)

    Time frame: 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.

  2. Change in gingival thickness phenotype (thin vs thick)

    Time frame: 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)

  3. Change in buccal cortical bone thickness on CBCT (mm)

    Time frame: 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

Secondary outcomes

  1. Probing pocket depth (mm)

    Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.

  2. Bleeding on probing (0/1)

    Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.

  3. Gingival Index (0-3)

    Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.

  4. Plaque Index (0-3)

    Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.

  5. Papilla loss classification (Nordland & Tarnow)

    Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.

  6. Gingival recession (mm)

    Time frame: Baseline and postoperative 1, 3, 6 months.

  7. Fenestration/dehiscence presence on CBCT (yes/no) (and/or counts)

    Time frame: Baseline and postoperative 6 months.

  8. Clinical attachment loss (mm)

    Time frame: Baseline and postoperative 1, 3, 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ece Açıkgöz-Alparslan

CONTACT

[email protected]

+902842364551

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Collaborators

  • Kocaeli Sağlık ve Teknoloji Üniversitesi

Registry information

Official study title

Evaluation of Periodontal Phenotype Following Orthognathic Surgery: A Two-Center, 6-Month Prospective Clinical and CBCT Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jun 8, 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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