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

Class III Malocclusion Clinical Trial

— RAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823325
• Other study ID #: bkilic001
• Status: Completed
• Start date: January 5, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: March 2021
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism
• Root Resorption

Intervention

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

Locations

Country	Name	City	State
Turkey	Banu Kilic	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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