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CompletedNCT04823325RAPUpdated Mar 30, 2021

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

An observational study in Class III Malocclusion and Root Resorption, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by Bezmialem Vakif University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Class III Malocclusion
  • Root Resorption
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Surgery patients

    Otherwise healthy patients with Skeletal Class III problem

    Procedure: Orthognathic Surgery

Interventions

  • ProcedureOrthognathic Surgery

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

05

What researchers measure

Primary outcomes

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

    IL- 6 RANKL

    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

  2. Assessing Change Between Two Time Points to Determine Root Resorption

    Morphologic changes in root apex

    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

06

Study locations

1 site
  • Banu Kilic
    Istanbul, Fatih 34844, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04823325
Lead sponsor
Bezmialem Vakif University
Responsible party
Sponsor
First posted
Mar 30, 2021
Start date
Jan 5, 2019
Primary completion
Jan 1, 2021
Completion
Jan 1, 2021
Last update
Mar 30, 2021

Study contacts

Banu Kilic
study director · Bezmialem Vakif University
Nisa Gül Amuk
principal investigator · TC Erciyes University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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