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

NCT07349056 | Not Yet Recruiting

• 1 other identifier: 2522A04
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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)

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

• 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

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

Secondary Outcomes (8)

• Probing pocket depth (mm)

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

• Bleeding on probing (0/1)

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

• Gingival Index (0-3)

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

• Plaque Index (0-3)

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

• Papilla loss classification (Nordland & Tarnow)

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

Study Arms (10)

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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead
• Kocaeli Sağlık ve Teknoloji Üniversitesi: collaborator

Study Sites (2)

Trakya University Faculty of Dentistry

Edirne, Turkey (Türkiye)

Location

Kocaeli Health and Technology University Faculty of Dentistry

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Ece Açıkgöz-Alparslan

CONTACT

+902842364551; eceacikgoz@trakya.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)