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

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

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.

Study Overview

• Status: Completed
• Conditions: Root Resorption; Class III Malocclusion
• Intervention / Treatment: Procedure: Orthognathic Surgery

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.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34844
      • Banu Kilic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study was started by collecting GCF before surgery from 25 patients. Patients who developed exclusion criteria while the study was in progress were excluded from the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery patients; Otherwise healthy patients with Skeletal Class III problem	Procedure: Orthognathic Surgery; The duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Study Director: Banu Kilic, Bezmialem Vakif University; Principal Investigator: Nisa Gül Amuk, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Tooth Resorption; Malocclusion; Root Resorption; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: bkilic001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No