Early Effects of Orthognathic Surgery on Periodontal Phenotype: A 6-Month Prospective Clinical and Radiographic Evaluation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorTrakya University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 10 trial groups10
Trial groupsSee each trial group below.
Group A: Group A (Mandibular setback < 6 mm)
Group B: Group B (Mandibular setback ≥ 6 mm)
Group C: Group C (Mandibular advancement < 6 mm)
Group D: Group D (Mandibular advancement ≥ 6 mm)
Group E: Group E (Maxillary advancement < 6 mm + maxillary impaction)
Group F: Group F (Maxillary advancement < 6 mm + maxillary downgrafting)
Group G: Group G (Maxillary advancement < 6 mm + no impaction/downgrafting)
Group H: Group H (Maxillary advancement ≥ 6 mm + maxillary impaction)
Group I: Group I (Maxillary advancement ≥ 6 mm + maxillary downgrafting)
Group J: Group J (Maxillary advancement ≥ 6 mm + no impaction/downgrafting)
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Trakya University
Lead sponsor
Kocaeli Sağlık ve Teknoloji Üniversitesi
Collaborator
Source ClinicalTrials.gov