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

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.

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Key information

Conditions

Class III Malocclusion Malocclusion Malocclusion, Angle Class III Root Resorption Stomatognathic Diseases Tooth Diseases Tooth Resorption

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Banu Kilic

Istanbul, Fatih, 34844, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Orthognathic Surgery

Procedure

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

Primary outcomes

Assessing Change Between Three Time Points of Biomarkers to Determine Effectiveness of Regional Acceleratory Phenomenon

Time frame: 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
Assessing Change Between Two Time Points to Determine Root Resorption

Time frame: 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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Acronym: RAP

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Mar 30, 2021
Registry last updated: Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed