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

NCT ID: NCT04823325

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-05

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Class III Malocclusion Root Resorption

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery patients

Otherwise healthy patients with Skeletal Class III problem

Orthognathic Surgery

Intervention Type PROCEDURE

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

Interventions

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Orthognathic Surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Banu Kilic

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Nisa Gül Amuk

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Banu Kilic

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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bkilic001

Identifier Type: -

Identifier Source: org_study_id