Early Effects of Orthognathic Surgery on Periodontal Phenotype: A 6-Month Prospective Clinical and Radiographic Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gingival Biotype, Gingival Phenotype, Buccal Bone Thickness, Recession, Gingival. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Periodontal Phenotype Following Orthognathic Surgery: A Two-Center, 6-Month Prospective Clinical and CBCT Study
Overview
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.
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.
Primary outcome measures
- Change in width of keratinized gingiva (mm) [Time frame: 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.]
- 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).]
Secondary outcome measures (8)
- Probing pocket depth (mm) [Time frame: 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.]
- Gingival Index (0-3) [Time frame: Baseline (preoperative) and postoperative 1, 3, and 6 months.]
- Plaque Index (0-3) [Time frame: 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.]
- Gingival recession (mm) [Time frame: Baseline and postoperative 1, 3, 6 months.]
- Fenestration/dehiscence presence on CBCT (yes/no) (and/or counts) [Time frame: Baseline and postoperative 6 months.]
- Clinical attachment loss (mm) [Time frame: Baseline and postoperative 1, 3, 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 2 centers
- Trakya University Faculty of Dentistry — Edirne
- Kocaeli Health and Technology University Faculty of Dentistry — Kocaeli
Identifiers
NCT: NCT07349056 · 2522A04