Determining the Presence of RAP in Orthognathic Patients and Its Effect on Root Resorption by Biomarkers

Study Overview
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Brief Summary
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A prospective clinical trial to what extent inflammatory biomarkers are affected by the medication after orthognathic surgery in early surgical cases and whether these biomarkers affects the amount of maxillary or mandibular incisor root resorption.

Detailed Description
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To conduct a prospective clinical trial to what extent inflammatory biomarkers such as OPG, RANKL, IL-1, IL-6, and CRP are affected by the medication after orthognathic surgery in early surgical cases and whether these biomarkers affects the amount of maxillary or mandibular incisor root resorption.

Official Title
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Use of Biomarkers in Early Surgery Patients to Determine Effectiveness of Regional Acceleratory Phenomenon and Its Effect on Root Resorption

Conditions
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Class III Malocclusion, Root Resorption

Intervention / Treatment
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* Procedure: Orthognathic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Have skeletal Cl III malocclusion Wisdom teeth are absent or extracted at least 6 months before the surgery Need of orthognathic surgery through Le Fort I osteotomy of the maxilla and bilateral sagittal split osteotomies (BSSO) of the mandible. Undergo fixed orthodontic treatment before and after the orthognathic surgery Have available orthopantomograms with adequate quality Have healthy periodontal tissue without inflammation or bleeding before and after the surgery. Maintain the same medication protocol during and after the surgery. Exclusion Criteria: ongoing use of regular medication smoking known penicillin allergy, any immune disorder, musculoskeletal diseases, syndromes, cleft lip-palate, systemic diseases affecting root resorption, periodontal and gingival disorders, missing teeth among upper or lower incisors, poor oral hygiene.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery patients<br>Otherwise healthy patients with Skeletal Class III problem | Procedure: Orthognathic Surgery<br>* The duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing Change Between Three Time Points of Biomarkers to Determine Effectiveness of Regional Acceleratory Phenomenon | IL- 6 RANKL | To see the change at biomarker levels GCF samples were collected at the time points designated as T0, T1, and T2 which correspond to the day of the surgery before anesthesia, 1 week after the surgery, and 4 weeks after the surgery | 
| Assessing Change Between Two Time Points to Determine Root Resorption | Morphologic changes in root apex | To see the change of root length all radiographs were taken digitally at t0 (at the beginning of orthodontic preparation), t1 (just before the orthognathic surgery), and t2 ( an average of 1,5 years postop) with an X-ray unit |