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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Change in width of keratinized gingiva (mm) [Срок оценки: Baseline (preoperative) and postoperative 1, 3, and 6 months.]
• Change in gingival thickness phenotype (thin vs thick) [Срок оценки: Baseline (preoperative) and postoperative 1, 3, and 6 months.]
• Change in buccal cortical bone thickness on CBCT (mm) [Срок оценки: Baseline (preoperative) and postoperative follow-up CBCT records were obtained during routine controls (planned at 6 months).]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 2 центра

• Trakya University Faculty of Dentistry — Edirne
• Kocaeli Health and Technology University Faculty of Dentistry — Kocaeli

Идентификаторы

NCT: NCT07349056 · 2522A04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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