Class III MalocclusionRAPNCT04823325
Determining the Presence of RAP in Orthognathic Patients and Its Effect on Root Resorption by Biomarkers
An observational study of Class III Malocclusion and Root Resorption, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Class III Malocclusion, Root Resorption
- What is being tested?
- Orthognathic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2019to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- ongoing use of regular medication
- smoking
- known penicillin allergy,
- any immune disorder,
- musculoskeletal diseases,
- syndromes,
Show all 11Show fewer
- cleft lip-palate,
- systemic diseases affecting root resorption,
- periodontal and gingival disorders,
- missing teeth among upper or lower incisors,
- poor oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Biomarkers in Early Surgery Patients to Determine Effectiveness of Regional Acceleratory Phenomenon and Its Effect on Root Resorption
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.
- Conditions
- Class III Malocclusion, Root Resorption
- Being tested
- Orthognathic Surgery
- Medical subject headings
- Malocclusion, Angle Class III, Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic SurgeryProcedure or surgery
The duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months.
| Study group | Role | What they receive |
|---|---|---|
| Surgery patients | Otherwise healthy patients with Skeletal Class III problem Receives: Procedure: Orthognathic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Change Between Three Time Points of Biomarkers to Determine Effectiveness of Regional Acceleratory Phenomenon
IL- 6 RANKL
Measured: 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
Assessing Change Between Two Time Points to Determine Root Resorption
Morphologic changes in root apex
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start5 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class III MalocclusionStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Banu Kilic, Study director, Bezmialem Vakif UniversityNisa Gül Amuk, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823325
- Sponsor's protocol ID
- bkilic001
- Acronym
- RAP
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biomarkers in Early Surgery Patients to Determine Effectiveness of Regional Acceleratory Phenomenon and Its Effect on Root Resorption
- ClinicalTrials.gov ID
- NCT04823325
- Acronym / sponsor ID
- RAP / bkilic001
- Conditions
- Class III Malocclusion, Root Resorption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery patients | – | Procedure: Orthognathic SurgeryOtherwise healthy patients with Skeletal Class III problem |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- ongoing use of regular medication
- smoking
- known penicillin allergy,
- any immune disorder,
- musculoskeletal diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthognathic SurgeryThe duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months. | Procedure or surgery | Surgery patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Banu Kilic study director
Bezmialem Vakif University
Nisa Gül Amuk principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Class III Malocclusion and Root Resorption, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.