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

February 12, 2026 updated by: Ece AÇIKGÖZ ALPARSLAN, Trakya University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Edirne, Turkey (Türkiye)
        • Trakya University Faculty of Dentistry
        • Contact:
        • Contact:
          • Gizem Kantarcı Arda
          • Phone Number: +902842364551
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli Health and Technology University Faculty of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients referred for orthognathic surgery to the Department of Oral and Maxillofacial Surgery at Kocaeli Health and Technology University and subsequently evaluated at the Department of Periodontology at Trakya University

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A (Mandibular setback < 6 mm)
Group B (Mandibular setback ≥ 6 mm)
Group C (Mandibular advancement < 6 mm)
Group D (Mandibular advancement ≥ 6 mm)
Group E (Maxillary advancement < 6 mm + maxillary impaction)
Group F (Maxillary advancement < 6 mm + maxillary downgrafting)
Group G (Maxillary advancement < 6 mm + no impaction/downgrafting)
Group H (Maxillary advancement ≥ 6 mm + maxillary impaction)
Group I (Maxillary advancement ≥ 6 mm + maxillary downgrafting)
Group J (Maxillary advancement ≥ 6 mm + no impaction/downgrafting)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (preoperative) and postoperative 1, 3, and 6 months.
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)
Baseline (preoperative) and postoperative 1, 3, and 6 months.
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
Baseline (preoperative) and postoperative follow-up CBCT records were obtained during routine controls (planned at 6 months).

Secondary Outcome Measures

Outcome Measure
Time Frame
Probing pocket depth (mm)
Time Frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Baseline (preoperative) and postoperative 1, 3, and 6 months.
Bleeding on probing (0/1)
Time Frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Baseline (preoperative) and postoperative 1, 3, and 6 months.
Gingival Index (0-3)
Time Frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Baseline (preoperative) and postoperative 1, 3, and 6 months.
Plaque Index (0-3)
Time Frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Baseline (preoperative) and postoperative 1, 3, and 6 months.
Papilla loss classification (Nordland & Tarnow)
Time Frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.
Baseline (preoperative) and postoperative 1, 3, and 6 months.
Gingival recession (mm)
Time Frame: Baseline and postoperative 1, 3, 6 months.
Baseline and postoperative 1, 3, 6 months.
Fenestration/dehiscence presence on CBCT (yes/no) (and/or counts)
Time Frame: Baseline and postoperative 6 months.
Baseline and postoperative 6 months.
Clinical attachment loss (mm)
Time Frame: Baseline and postoperative 1, 3, 6 months
Baseline and postoperative 1, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Collaborators

Kocaeli Sağlık ve Teknoloji Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 23, 2026

Primary Completion (Estimated)

February 23, 2027

Study Completion (Estimated)

February 23, 2027

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2522A04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data containing personal health information will not be shared due to privacy and confidentiality requirements, as well as ethical restrictions and applicable standards

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recession, Gingival

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe