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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04823325
Acronym
RAP
Enrollment
13
Registered
2021-03-30
Start date
2019-01-05
Completion date
2021-01-01
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class III Malocclusion, Root Resorption

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.

Interventions

PROCEDUREOrthognathic Surgery

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

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessing Change Between Three Time Points of Biomarkers to Determine Effectiveness of Regional Acceleratory PhenomenonTo 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 surgeryIL- 6 RANKL
Assessing Change Between Two Time Points to Determine Root ResorptionTo 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 unitMorphologic changes in root apex

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026