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

NCT04823325 | Completed DMC

• 1 other identifier: bkilic001
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class III Malocclusion; Root Resorption

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Surgery patients

Otherwise healthy patients with Skeletal Class III problem

Procedure: Orthognathic Surgery

Interventions

Orthognathic Surgery PROCEDURE

The duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months.

Surgery patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Banu Kilic

Istanbul, Fatih, 34844, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

gingival crevicular fluid

MeSH Terms

Conditions

Malocclusion, Angle Class III; Root Resorption

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Tooth Resorption

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Banu Kilic

  Bezmialem Vakif University

  STUDY DIRECTOR

• Nisa Gül Amuk

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 30, 2021
• Study Start: January 5, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)