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

Completed

• Conditions: Class III Malocclusion; Root Resorption
• Interventions: Procedure: Orthognathic Surgery

• Registration Number: NCT04823325
• Lead Sponsor: Bezmialem Vakif University

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.

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 Timeline

• Study Start: 2019-01-05
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-29
• Last Update Submitted: 2021-03-29
• Study First Posted: 2021-03-30
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery patients	Orthognathic Surgery	Otherwise healthy patients with Skeletal Class III problem

Primary Outcome Measures

Name	Time	Method
Assessing Change Between Two Time Points to Determine Root Resorption	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
Assessing Change Between Three Time Points of Biomarkers to Determine Effectiveness of Regional Acceleratory Phenomenon	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

Trial Locations

Locations (1)

Banu Kilic; 🇹🇷 Istanbul, Fatih, Turkey