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

June 5, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trakya University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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