Cytokine MeasurementsNCT02887547
Biological Markers Evaluation of Accelerated Tooth Movement
A study testing micro-osteoperforation in people with Cytokine Measurements and Orthodontic Space Closure, run by University of Sao Paulo.
Trial summary
Gingival Crevicular Fluid samples will be collected using periopapers after accelerated tooth movement technique, results will be assessed with biomarkers levels done using ELISA Assays Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytokine Measurements, Orthodontic Space Closure, Tooth Movement
- What is being tested?
- micro-osteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to May 2020
- Phase
- Interventional
- 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
Who may be able to join
- Adult subjects ages 18-40 years old, in good general health, with adult complete dentition, regardless of presence of third molars.
- Indication for orthognathic surgery
- Tooth extraction indication for orthodontic treatment
- Do not smoke
- Periodontal and teeth healthy
- Do not use bisphosphonates or corticosteroids
Who cannot join
- Surgically assisted rapid palatal expansion indication
- Cleft lip and palate
- Craniofacial syndrome
- Mental disorder
- Metabolic diseases
About this study
Official title: Biomarkers Expression in Gingival Crevicular Fluid and Accelerated Tooth Movement
Gingival Crevicular Fluid samples will be collected using periopapers after accelerated tooth movement technique, results will be assessed with biomarkers levels done using ELISA Assays
Read the detailed description
For this prospective study, 22 individuals were selected, with skeletal discrepancies randomly divided into two groups: 1 - accelerated tooth movement technique (ATMT) and 2 - Control.
Orthodontic records done in two times, initial and preoperative; Gingival Crevicular Fluid samples will be collected using periopapers in 7 times (1, 2, 7, 14, 28 days and after space closure- end of orthodontic treatment movement activation).
Flapless cortical perforations will be made in ATMT Group after dental extraction. Surgical protocol will be flapless to preserve periodontal health.
After extraction space closure, results will be assessed by clinical effects with biological markers levels:
CCL3/MIP-1 alpha, CCL5/RANTES, CXCL8/IL8, IL-1 alpha, IL-1 beta, IL6, TNF-alpha, TRANCE/RANK L, OCN OPG IL-10 VEGF TGF-ℬ
Those biomarkers levels will be performed using ELISA Assays. After collecting data, the results will be statistically analyzed using Shapiro-Wilk and, posteriorly, T-student or Wilcoxon.
- Being tested
- micro-osteoperforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-osteoperforationProcedure or surgery
Also called accelerated tooth movement
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group, with traditional orthodontic mechanics for anterior retraction. Crevicular fluid will be collected during anterior retraction mechanics to identified biomarkers in the inflammatory process |
| Acceleration | Experimental | Group with micro-osteoperforation for accelerated tooth movement during anterior retraction, Crevicular fluid will be collected during anterior retraction mechanics to identified biomarkers in the inflammatory process Receives: Procedure: micro-osteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Cytokines ad Chemokines Detection Assay
Measure the different levels of listed cytokines and chemokines after starting the anterior retraction
Measured: 8 months
Bone remodeling markers in GCF samples
Measure the different levels of resorption biomarkers and bone formation after starting the anterior retraction
Measured: 8 monnths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2018
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine MeasurementsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANA FATTORI ABATI, University of Sao Paulo
- Investigators
- Liana Fattori, MS PhD, Principal investigator, Phd candidateJose Rino Neto, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887547
- Sponsor's protocol ID
- Fattori2
- Status last verified
- Jun 2019
- First submitted
- 20 Dec 2015
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Expression in Gingival Crevicular Fluid and Accelerated Tooth Movement
- ClinicalTrials.gov ID
- NCT02887547
- Acronym / sponsor ID
- Fattori2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- May 2020 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- 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.
Gingival Crevicular Fluid samples will be collected using periopapers after accelerated tooth movement technique, results will be assessed with biomarkers levels done using ELISA Assays
Detailed description
For this prospective study, 22 individuals were selected, with skeletal discrepancies randomly divided into two groups: 1 - accelerated tooth movement technique (ATMT) and 2 - Control.
Orthodontic records done in two times, initial and preoperative; Gingival Crevicular Fluid samples will be collected using periopapers in 7 times (1, 2, 7, 14, 28 days and after space closure- end of orthodontic treatment movement activation).
Flapless cortical perforations will be made in ATMT Group after dental extraction. Surgical protocol will be flapless to preserve periodontal health.
After extraction space closure, results will be assessed by clinical effects with biological markers levels:
CCL3/MIP-1 alpha, CCL5/RANTES, CXCL8/IL8, IL-1 alpha, IL-1 beta, IL6, TNF-alpha, TRANCE/RANK L, OCN OPG IL-10 VEGF TGF-ℬ
Those biomarkers levels will be performed using ELISA Assays. After collecting data, the results will be statistically analyzed using Shapiro-Wilk and, posteriorly, T-student or Wilcoxon.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group, with traditional orthodontic mechanics for anterior retraction. Crevicular fluid will be collected during anterior retraction mechanics to identified biomarkers in the inflammatory process |
| Acceleration | Experimental | Procedure: micro-osteoperforationGroup with micro-osteoperforation for accelerated tooth movement during anterior retraction, Crevicular fluid will be collected during anterior retraction mechanics to identified biomarkers in the inflammatory process |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult subjects ages 18-40 years old, in good general health, with adult complete dentition, regardless of presence of third molars.
- Indication for orthognathic surgery
- Tooth extraction indication for orthodontic treatment
- Do not smoke
- Periodontal and teeth healthy
Key exclusion criteria (5 listed)
- Surgically assisted rapid palatal expansion indication
- Cleft lip and palate
- Craniofacial syndrome
- Mental disorder
- Metabolic 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 |
|---|---|---|
| micro-osteoperforationAlso: accelerated tooth movement | Procedure or surgery | Acceleration |
Primary outcome
Inflammatory Cytokines ad Chemokines Detection Assay
Time frame: 8 months
Measure the different levels of listed cytokines and chemokines after starting the anterior retraction
Bone remodeling markers in GCF samples
Time frame: 8 monnths
Measure the different levels of resorption biomarkers and bone formation after starting the anterior retraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
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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.
Liana Fattori, MS PhD principal investigator
Phd candidate
Jose Rino Neto study chair
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing micro-osteoperforation in people with Cytokine Measurements and Orthodontic Space Closure, run by University of Sao Paulo.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Inflammatory Cytokines ad Chemokines Detection Assay (time frame: 8 months). 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 1 Jul 2019.