Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:09 PM
Study NCT ID:
NCT07349056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Effects of Orthognathic Surgery on Periodontal Phenotype: A 6-Month Prospective Clinical and Radiographic Evaluation
Sponsor:
Trakya University
Organization:
Study Overview
Official Title:
Evaluation of Periodontal Phenotype Following Orthognathic Surgery: A Two-Center, 6-Month Prospective Clinical and CBCT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: