ClinicalTrials.gg
RecruitingNCT07349056Updated Jun 8, 2026

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

An observational study in Gingival Biotype, Gingival Phenotype and Buccal Bone Thickness, sponsored by Trakya University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Trakya University · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 65 Years
Sex
All
01

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.
Read the 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.

02

Conditions studied

  • Gingival Biotype
  • Gingival Phenotype
  • Buccal Bone Thickness
  • Recession, Gingival
  • Dental Surgery

Browse trials for

03

In context

Gingival Recession

426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.

This study's planned enrollment of 100 is above the median of 48 across 31 observational studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

Trakya University is the lead sponsor of 155 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 form.
  • Individuals belonging to a vulnerable population.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)
06

What researchers measure

Primary outcomes

  1. Change in width of keratinized gingiva (mm)

    Width of keratinized gingiva is measured as the distance from the gingival margin to the mucogingival junction, recorded in mm.

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

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

    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)

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

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

    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

    Time frame: Baseline (preoperative) and postoperative follow-up CBCT records were obtained during routine controls (planned at 6 months).

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

07

Study locations

2 of 2 sites recruiting
  • Trakya University Faculty of Dentistry
    Edirne, Turkey (Türkiye)
    Recruiting
    • Ece Açıkgöz- Alparslan · Contacteceacikgoz@trakya.edu.tr · +902842364551
    • Gizem Kantarcı Arda · Contact+902842364551
  • Kocaeli Health and Technology University Faculty of Dentistry
    Kocaeli, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — 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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2026
First posted
Jan 16, 2026
StartActual
Feb 23, 2026
Primary completionEst.
Feb 23, 2027
CompletionEst.
Feb 23, 2027
Last update
Jun 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07349056
Lead sponsor
Trakya University
Collaborators
Kocaeli Sağlık ve Teknoloji Üniversitesi
Responsible party
Ece AÇIKGÖZ ALPARSLAN (Ass. Prof, Trakya University) — Principal investigator
First posted
Jan 16, 2026
Start date
Feb 23, 2026
Primary completion
Feb 23, 2027 (estimated)
Completion
Feb 23, 2027 (estimated)
Last update
Jun 8, 2026

Study contacts

Ece Açıkgöz-Alparslan
Contact
eceacikgoz@trakya.edu.tr
+902842364551

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion