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

Overview

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.

Full Title of Study: “Use of Biomarkers in Early Surgery Patients to Determine Effectiveness of Regional Acceleratory Phenomenon and Its Effect on Root Resorption”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2021

Detailed Description

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.

Interventions

  • Procedure: Orthognathic Surgery
    • The duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months.

Arms, Groups and Cohorts

  • Surgery patients
    • Otherwise healthy patients with Skeletal Class III problem

Clinical Trial Outcome Measures

Primary Measures

  • Assessing Change Between Three Time Points of Biomarkers to Determine Effectiveness of Regional Acceleratory Phenomenon
    • Time Frame: 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
    • IL- 6 RANKL
  • Assessing Change Between Two Time Points to Determine Root Resorption
    • Time Frame: 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
    • Morphologic changes in root apex

Participating in This Clinical Trial

Inclusion Criteria 1. Have skeletal Cl III malocclusion 2. Wisdom teeth are absent or extracted at least 6 months before the surgery 3. Need of orthognathic surgery through Le Fort I osteotomy of the maxilla and bilateral sagittal split osteotomies (BSSO) of the mandible. 4. Undergo fixed orthodontic treatment before and after the orthognathic surgery 5. Have available orthopantomograms with adequate quality 6. Have healthy periodontal tissue without inflammation or bleeding before and after the surgery. 7. Maintain the same medication protocol during and after the surgery. Exclusion Criteria:

1. ongoing use of regular medication 2. smoking 3. known penicillin allergy, 4. any immune disorder, 5. musculoskeletal diseases, 6. syndromes, 7. cleft lip-palate, 8. systemic diseases affecting root resorption, 9. periodontal and gingival disorders, 10. missing teeth among upper or lower incisors, 11. poor oral hygiene.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Banu Kilic, Study Director, Bezmialem Vakif University
    • Nisa Gül Amuk, Principal Investigator, TC Erciyes University

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