HealthyNCT04226469
Gingival Crevicular Fluid Characterization During Orthodontic Treatment
An observational study of Healthy and Maxillary First Premolar Tooth Extraction, run by University of Illinois Chicago at 1 site in United States.
Trial summary
During Orthodontic tooth movement, teeth are moved through alveolar bone under applied forces. The applied mechanical loading force must be transferred to the alveolar bone via periodontal ligament (PDL). Read more about this study
- Who is it for?
- Ages 11 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Maxillary First Premolar Tooth Extraction, Canine Retraction
- What is being tested?
- Tooth movement
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 5 May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy, non-smoking patients aged 11-35 years old who require orthodontic treatment with first premolar extraction at the orthodontic clinic at College of Dentistry, University of Illinois at Chicago (UIC)
Who may be able to join
- Healthy, non-smoking patients aged 11-35 years old who require orthodontic treatment with the first premolar extraction at the orthodontic clinic at College of Dentistry, the University of Illinois at Chicago (UIC)
Who cannot join
- Craniofacial syndromic subjects
- periodontal pathology
- systemic problems and underlying diseases
- smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Orthodontics, Clinic
Chicago, Illinois, 60612
About this study
Official title: Characterization of Gingival Crevicular Fluid During Orthodontic Tooth Movement
During Orthodontic tooth movement, teeth are moved through alveolar bone under applied forces. The applied mechanical loading force must be transferred to the alveolar bone via periodontal ligament (PDL). This process of mechanotransduction stimulates bone remodeling during which osteoblasts produce bone on the tension side and osteoclasts resorb bone on the compression side of the PDL. Complex interactions between osteoblasts and osteoclasts involve numerous biologic molecules including cytokines and growth factors. During the tooth movement, the expression of cytokines such as interleukin (IL)-1β, IL-6, IL-8, prostaglandin E2, RANKL and MMP1 in PDL will be up-regulated. The sequence of events from the mechanotransduction commanding the tightly controlled accomplishment of osteogenesis attention sides and osteoclastogenesis at compressive sides is not completely understood.
The gingival crevicular fluid (GCF) is a transudate of interstitial tissues that is produced by an osmotic gradient and it is released into the crevicular crevices at a flow rate of about 3 ul/h. Orthodontic treatment is triggered by an inflammatory process and it has been hypothesized that the quantification of specific biomarkers within the GCF can be determined using Periotron. However contrasting results have been reported in the literature, which studies showing both increased or unchanged GCF volumes incident to orthodontic treatment.
Read more
Given that the orthodontic treatment is triggered by a set of inflammatory cytokines that are released into the crevicular fluid during the mechanical loading, and its homeostasis is dependent on mechanical stimulation. An understanding of the biological response of crevicular fluid to mechanical loading could further advance the knowledge of orthodontic treatment.
In this study, the investigators will investigate the biological response of gingival crevicular fluid before and after the initial wire placement of orthodontic treatment to determine the differentially expressed genes and proteins related to mechanotransduction.
Read the detailed description
Eligibility criteria for the collection of gingival crevicular fluid One Hundred healthy, non-smoking patients aged 11-35 years old who require orthodontic treatment with first premolar extraction at the orthodontic clinic at College of Dentistry, the University of Illinois at Chicago (UIC) will be included. The informed consent will be presented to patients and parent(s) [legal guardian(s)] and signed before the procedure. The patient will be screened for the inclusion criteria at the time of consent. The written assent will also be obtained from minor subjects. Before the treatment, periapical radiographs will be taken on both maxillary canines to verify the root length and morphology so the pre-fabricated power arms on the canine brackets will be closed to the center of resistance of the canines. Fixed orthodontic appliances (0.018-in; MBT prescription) will be placed in the subject with an auxiliary vertical slot in the maxillary canine brackets (Dentsply International, York, NY) to accommodate the prefabricated power arms. The subjects will be referred for extraction of the maxillary first premolars. A temporary anchorage device will be placed between the maxillary second premolar and maxillary first molar, 5 mm from alveolar crest for anchorage and reference purposes. The teeth in the maxillary arch will be leveled and aligned before canine retraction. Once 0.016x0.016 stainless steel archwires (Dentsply International) are placed, the canine retraction will be achieved using calibrated 70-g nickel-titanium closing-coil springs (Dentsply International) connected from a temporary anchorage device to the power arm on the canine brackets that allowed the application of the force closer to the center of resistance of the tooth.
Collection of gingival crevicular fluid Patients will be seated in the dental chair in an upright position. The selected site will be air-dried and isolated with cotton rolls. Without touching the marginal gingiva, supragingival plaque will be removed to avoid contamination of the paper strips. The absorbent paper strips will be placed gently in the sulcus and the absorbed paper strips will be pooled and placed in a sterile Eppendorf tube containing 200 ul of phosphate buffer saline. The collected sample will be coded with unique ID numbers and kept at -80C until analyzed. The key for the identifications will be kept in a locked cabinet in Rm#237B, College of Dentistry. The patient will be informed not to take NSAIDs but paracetamol after the orthodontic treatment. The collection of GCF will be performed before bracket placement, before canine retraction, 2 weeks after canine retraction, 5 weeks after canine retraction and 7 weeks after canine retraction.
Intraoral scanning The patients' occlusion and jaws will be scanned using an intraoral digital scanner. The intraoral scanning will be performed at the highest resolution at each studied timepoint. The scanning data will be exported as stereolithography binary file format (.stl) and imported to a sophisticated processing software package (Geomagic® Control 14, Geomagic®, Research Triangle Park, NC, USA). The miniscrews and palatal rugae structure will be used as reference points
Wire placement and orthodontic treatment The patients will be bonded with brackets and 0.016x0.016" stainless steel wire will be placed and ligated onto the brackets with rubber rings. The patient will be scheduled to come back for the orthodontic treatment according to the sample collection time and once a month after the study.
ELISA The GCF samples will first be homogenized for 30 s and centrifuged for 5 min at 1500 g to elute. The elute will then used as a sample for ELISA estimation from GCF samples. The GCF sample will be detected OPG and RANKL. The ration of OPG and RANKL will be calculated and determine the potential of PDL to activate osteoclasts.
microRNA analysis Total RNA will be extracted from the stored GCF samples using miRNeasy serum/plasma kit (Qiagen, Valencia, CA). Quantity of the total RNA will be determined by NanoDrop spectrophotometer (Thermoscientific). The total RNA will be subjected to quantitative realtime RT-PCR using Taqman® microRNA RT-PCR assays specific to hsa-miR-21, -29a, b and c. hsa-let-7d, g and i will be used as an internal control. The samples from each subject will be analyzed using a 7900HT realtime PCR system (Applied Biosystems).
- Being tested
- Tooth movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth movementProcedure or surgery
The subject's canines will be retracted distally and crevicular fluid is collected
| Study group | Role | What they receive |
|---|---|---|
| Subjects require canine retraction | Subjects require canine retraction during orthodontic tooth movement and their gingival crevicular fluid is collected during the tooth movement. The control is the initial timepoint. Receives: Procedure: Tooth movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Distance of Tooth Movement
The distance of tooth movement from initial timepoint to the end of study
Measured: 7 weeks
The Fold Change of Secretory microRNA Expression
The fold change of secretory microRNA expression compared to the initial level
Measured: 7 weeks
The Amount of Crevicular Fluid
the volume of crevicular fluid during the tooth movement
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jan 2019
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phimon Atsawasuwan, University of Illinois Chicago
- Investigators
- Phimon Atsawasuwan, DDS, MS, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226469
- Sponsor's protocol ID
- 2013-0183
- Status last verified
- May 2025
- First submitted
- 6 Jan 2020
- Last updated
- 7 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Gingival Crevicular Fluid During Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT04226469
- Acronym / sponsor ID
- 2013-0183
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 7 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During Orthodontic tooth movement, teeth are moved through alveolar bone under applied forces. The applied mechanical loading force must be transferred to the alveolar bone via periodontal ligament (PDL). This process of mechanotransduction stimulates bone remodeling during which osteoblasts produce bone on the tension side and osteoclasts resorb bone on the compression side of the PDL. Complex interactions between osteoblasts and osteoclasts involve numerous biologic molecules including cytokines and growth factors. During the tooth movement, the expression of cytokines such as interleukin (IL)-1β, IL-6, IL-8, prostaglandin E2, RANKL and MMP1 in PDL will be up-regulated. The sequence of events from the mechanotransduction commanding the tightly controlled accomplishment of osteogenesis attention sides and osteoclastogenesis at compressive sides is not completely understood.
The gingival crevicular fluid (GCF) is a transudate of interstitial tissues that is produced by an osmotic gradient and it is released into the crevicular crevices at a flow rate of about 3 ul/h. Orthodontic treatment is triggered by an inflammatory process and it has been hypothesized that the quantification of specific biomarkers within the GCF can be determined using Periotron. However contrasting results have been reported in the literature, which studies showing both increased or unchanged GCF volumes incident to orthodontic treatment.
Given that the orthodontic treatment is triggered by a set of inflammatory cytokines that are released into the crevicular fluid during the mechanical loading, and its homeostasis is dependent on mechanical stimulation. An understanding of the biological response of crevicular fluid to mechanical loading could further advance the knowledge of orthodontic treatment.
In this study, the investigators will investigate the biological response of gingival crevicular fluid before and after the initial wire placement of orthodontic treatment to determine the differentially expressed genes and proteins related to mechanotransduction.
Detailed description
Eligibility criteria for the collection of gingival crevicular fluid One Hundred healthy, non-smoking patients aged 11-35 years old who require orthodontic treatment with first premolar extraction at the orthodontic clinic at College of Dentistry, the University of Illinois at Chicago (UIC) will be included. The informed consent will be presented to patients and parent(s) [legal guardian(s)] and signed before the procedure. The patient will be screened for the inclusion criteria at the time of consent. The written assent will also be obtained from minor subjects. Before the treatment, periapical radiographs will be taken on both maxillary canines to verify the root length and morphology so the pre-fabricated power arms on the canine brackets will be closed to the center of resistance of the canines. Fixed orthodontic appliances (0.018-in; MBT prescription) will be placed in the subject with an auxiliary vertical slot in the maxillary canine brackets (Dentsply International, York, NY) to accommodate the prefabricated power arms. The subjects will be referred for extraction of the maxillary first premolars. A temporary anchorage device will be placed between the maxillary second premolar and maxillary first molar, 5 mm from alveolar crest for anchorage and reference purposes. The teeth in the maxillary arch will be leveled and aligned before canine retraction. Once 0.016x0.016 stainless steel archwires (Dentsply International) are placed, the canine retraction will be achieved using calibrated 70-g nickel-titanium closing-coil springs (Dentsply International) connected from a temporary anchorage device to the power arm on the canine brackets that allowed the application of the force closer to the center of resistance of the tooth.
Collection of gingival crevicular fluid Patients will be seated in the dental chair in an upright position. The selected site will be air-dried and isolated with cotton rolls. Without touching the marginal gingiva, supragingival plaque will be removed to avoid contamination of the paper strips. The absorbent paper strips will be placed gently in the sulcus and the absorbed paper strips will be pooled and placed in a sterile Eppendorf tube containing 200 ul of phosphate buffer saline. The collected sample will be coded with unique ID numbers and kept at -80C until analyzed. The key for the identifications will be kept in a locked cabinet in Rm#237B, College of Dentistry. The patient will be informed not to take NSAIDs but paracetamol after the orthodontic treatment. The collection of GCF will be performed before bracket placement, before canine retraction, 2 weeks after canine retraction, 5 weeks after canine retraction and 7 weeks after canine retraction.
Intraoral scanning The patients' occlusion and jaws will be scanned using an intraoral digital scanner. The intraoral scanning will be performed at the highest resolution at each studied timepoint. The scanning data will be exported as stereolithography binary file format (.stl) and imported to a sophisticated processing software package (Geomagic® Control 14, Geomagic®, Research Triangle Park, NC, USA). The miniscrews and palatal rugae structure will be used as reference points
Wire placement and orthodontic treatment The patients will be bonded with brackets and 0.016x0.016" stainless steel wire will be placed and ligated onto the brackets with rubber rings. The patient will be scheduled to come back for the orthodontic treatment according to the sample collection time and once a month after the study.
ELISA The GCF samples will first be homogenized for 30 s and centrifuged for 5 min at 1500 g to elute. The elute will then used as a sample for ELISA estimation from GCF samples. The GCF sample will be detected OPG and RANKL. The ration of OPG and RANKL will be calculated and determine the potential of PDL to activate osteoclasts.
microRNA analysis Total RNA will be extracted from the stored GCF samples using miRNeasy serum/plasma kit (Qiagen, Valencia, CA). Quantity of the total RNA will be determined by NanoDrop spectrophotometer (Thermoscientific). The total RNA will be subjected to quantitative realtime RT-PCR using Taqman® microRNA RT-PCR assays specific to hsa-miR-21, -29a, b and c. hsa-let-7d, g and i will be used as an internal control. The samples from each subject will be analyzed using a 7900HT realtime PCR system (Applied Biosystems).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects require canine retraction | – | Procedure: Tooth movementSubjects require canine retraction during orthodontic tooth movement and their gingival crevicular fluid is collected during the tooth movement. The control is the initial timepoint. |
Who may qualify
- Ages
- 11 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy, non-smoking patients aged 11-35 years old who require orthodontic treatment with first premolar extraction at the orthodontic clinic at College of Dentistry, University of Illinois at Chicago (UIC)
Key inclusion criteria (1 listed)
- Healthy, non-smoking patients aged 11-35 years old who require orthodontic treatment with the first premolar extraction at the orthodontic clinic at College of Dentistry, the University of Illinois at Chicago (UIC)
Key exclusion criteria (4 listed)
- Craniofacial syndromic subjects
- periodontal pathology
- systemic problems and underlying diseases
- smoking
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 |
|---|---|---|
| Tooth movementThe subject's canines will be retracted distally and crevicular fluid is collected | Procedure or surgery | Subjects require canine retraction |
Primary outcome
The Distance of Tooth Movement
Time frame: 7 weeks
The distance of tooth movement from initial timepoint to the end of study
The Fold Change of Secretory microRNA Expression
Time frame: 7 weeks
The fold change of secretory microRNA expression compared to the initial level
The Amount of Crevicular Fluid
Time frame: 7 weeks
the volume of crevicular fluid during the tooth movement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Phimon Atsawasuwan, DDS, MS, PhD principal investigator
University of Illinois Chicago
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 Healthy and Maxillary First Premolar Tooth Extraction, run by University of Illinois Chicago at 1 site in United States.
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 1 inclusion and 4 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 7 May 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Distance of Tooth Movement (time frame: 7 weeks). The study lists 3 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 7 May 2025.