Early Effects of Orthognathic Surgery on Gum and Bone Health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This two-center prospective observational study enrolls adults undergoing orthognathic surgery. Researchers will measure gum phenotype and buccal bone thickness before surgery and at 1, 3, and 6 months post-operatively, using clinical periodontal exams and CBCT imaging. A standardized protocol and blinded assessments are used to reduce bias in evaluating periodontal parameters and tooth-supporting bone changes. Data will help describe how gingival phenotype and buccal bone respond to jaw realignment procedures over the early postoperative period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Trakya University Faculty of Dentistry
  Edirne, Turkey (Türkiye) Recruiting
• Kocaeli Health and Technology University Faculty of Dentistry
  Kocaeli, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Ece Açıkgöz-Alparslan
• Email: eceacikgoz@trakya.edu.tr
• Phone: +902842364551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.