Clinical trial NCT04823325: Determining the Presence of RAP in Orthognathic Patients and Its Effect on Root Resorption by Biomarkers
Official title: Use of Biomarkers in Early Surgery Patients to Determine Effectiveness of Regional Acceleratory Phenomenon and Its Effect on Root Resorption
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Class III Malocclusion
Root Resorption
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessing Change Between Three Time Points of Biomarkers to Determine Effectiveness of Regional Acceleratory Phenomenon
timeFrame: 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
measure: Assessing Change Between Two Time Points to Determine Root Resorption
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Banu Kilic
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Banu Kilic
role: STUDY_DIRECTOR
affiliation: TC Erciyes University
name: Nisa Gül Amuk
role: PRINCIPAL_INVESTIGATOR
References: