Orthodontic Tooth MovementNCT04022252
Investigation of the Photobiomodulation Applications
A study testing Cheese dental laser and OrthoPulse in people with Orthodontic Tooth Movement, run by University of Gaziantep.
Trial summary
Increasing the speed of orthodontic treatment is an emerging clinical problem and therefore the evaluation of the effects of photobiomodulation applications and methods on orthodontic tooth movement is considered as an important factor. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Cheese dental laser and OrthoPulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Feb 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- adequate oral hygiene
- Class 2 malocclusion requiring upper-premolar extraction orthodontic treatment
- lack of congenital missing teeth in upper jaw
- no systemic disease
Who cannot join
- patients who wish to discontinue treatment
- patients who cannot provide oral hygiene
Trial locations and contacts
No sites are listed yet.
Aslihan Karakas, MS contact
About this study
Official title: Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement
Increasing the speed of orthodontic treatment is an emerging clinical problem and therefore the evaluation of the effects of photobiomodulation applications and methods on orthodontic tooth movement is considered as an important factor.
When literature studies are examined, different studies have been performed on Laser and LED applications, however, the lack of a study that evaluates and compares the effectiveness of these methods in terms of clinical and biochemical parameters.
Read more
The aim of this study is to compare the effects of laser and LED applications on tooth movement speed and to investigate the effects of these applications on the gingival fluid IL-8, OPG, RANKL. Total of 24 patients with maxillary first-premolar extraction orthodontic treatment will be included in this study, and this study will consist of 3 groups, Laser, LED and placebo group. The laser will be applied on days 0,3,7,14,21,28,35, take impression of teeth and gingival fluid samples will be collected in these days.
LED group will be given 10 minutes LED for 30 days, taken impression and DOS samples will be collected on specified days. In the placebo group, the non-active pulse laser light will be kept in the teeth and the patients will not know which group in they are. Thus, the psychological dimension of the applications will be eliminated. Sampling will be done for the placebo group on the days determined.
The investigator's project proposal consists of a total of 5 work packages; Determination of patient groups in the 1st stage and obtaining consent forms, 2nd stage Photobiomodulation applications (laser, LED, placebo application), 3rd stage orthodontic measurement and evaluation of these measurements 3D environment, taking gingival fluid samples in the 4th stage and evaluating them biochemically. In the 5th stage, statistical analysis and evaluation of the results will be done.
The data will be evaluated with SPSS 21.0.In this study, it is tried to reduce the time spent in the orthodontic treatment to close the extraction area. In this way, it will contribute to economy and time saving in terms of all orthodontic treatment physicians and physicians. It will illuminate the application of LED device which is more advantageous in terms of cost and space gain in clinical practice of physicians.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Cheese dental laser, OrthoPulse, Placebo
- Keywords
- orthodontics, tooth movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheese dental laserDevice
810 nm GaAlAs diode laser device
OrthoPulseDevice
850 nm LED (light emitting diode)
PlaceboOther
810 nm GaAlAs diode laser device
| Study group | Role | What they receive |
|---|---|---|
| Tooth Movement | Experimental | Canine distalization on premolar extracted patients Receives: Device: Cheese dental laser; Device: OrthoPulse; Other: Placebo |
| Biochemistry measurements | Experimental | biochemistry analysis of IL-8, OPG, RANKL Receives: Device: Cheese dental laser; Device: OrthoPulse; Other: Placebo |
| periodontal measurements | Experimental | gingival and plaque index, blooding on probing, pocket depth Receives: Device: Cheese dental laser; Device: OrthoPulse; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic tooth movement Change
Measurement of orthodontic tooth movement (mm)
Measured: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Secondary outcomes (7)
Gingival Index Change
Measurements of gingival index (according to Silness\&Löe) all of teeth from 6 surface. Scale ranged from 0 to 3. All data will calculated for total mouth score.
Measured: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Plaque Index Change
Measurements of gingival index (according to Löe\&Silness) all of teeth from 6 surface. Scale ranged from 0 to 3. All data will calculated for total mouth score.
Measured: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
RANKL Change
Analyses of RANKL level in gingival crevicular fluid. The analysis will perform via ELISA. Data will present "pg/30sn"
Measured: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
OPG Change
Analyses of OPG in gingival crevicular fluid
Measured: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
IL-8 Change
Analyses of IL-8 in gingival crevicular fluid
Measured: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Bleeding on Probing Change
Estimation of bleeding on probing. The reason for the Bleeding of Probing measurement is for the control of oral hygiene motivations in patients' follow-up.
Measured: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Periodontal Pocket Depth Change
Measurement of Periodontal Pocket Depth (mm)
Measured: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Tooth MovementStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Goymen, University of Gaziantep
- Investigators
- Hasan Gundogar, PhD, Study chair, Gaziantep University Periodontology DepartmentSeyithan Taysi, Prof, Study chair, Gaziantep University Biochemistry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022252
- Sponsor's protocol ID
- 261
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 18 Jul 2019
- 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 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT04022252
- Acronym / sponsor ID
- 261
- Conditions
- Orthodontic Tooth Movement
- Keywords
- orthodontics, tooth movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 17 Jul 2019 (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.
Increasing the speed of orthodontic treatment is an emerging clinical problem and therefore the evaluation of the effects of photobiomodulation applications and methods on orthodontic tooth movement is considered as an important factor.
When literature studies are examined, different studies have been performed on Laser and LED applications, however, the lack of a study that evaluates and compares the effectiveness of these methods in terms of clinical and biochemical parameters.
The aim of this study is to compare the effects of laser and LED applications on tooth movement speed and to investigate the effects of these applications on the gingival fluid IL-8, OPG, RANKL. Total of 24 patients with maxillary first-premolar extraction orthodontic treatment will be included in this study, and this study will consist of 3 groups, Laser, LED and placebo group. The laser will be applied on days 0,3,7,14,21,28,35, take impression of teeth and gingival fluid samples will be collected in these days.
LED group will be given 10 minutes LED for 30 days, taken impression and DOS samples will be collected on specified days. In the placebo group, the non-active pulse laser light will be kept in the teeth and the patients will not know which group in they are. Thus, the psychological dimension of the applications will be eliminated. Sampling will be done for the placebo group on the days determined.
The investigator's project proposal consists of a total of 5 work packages; Determination of patient groups in the 1st stage and obtaining consent forms, 2nd stage Photobiomodulation applications (laser, LED, placebo application), 3rd stage orthodontic measurement and evaluation of these measurements 3D environment, taking gingival fluid samples in the 4th stage and evaluating them biochemically. In the 5th stage, statistical analysis and evaluation of the results will be done.
The data will be evaluated with SPSS 21.0.In this study, it is tried to reduce the time spent in the orthodontic treatment to close the extraction area. In this way, it will contribute to economy and time saving in terms of all orthodontic treatment physicians and physicians. It will illuminate the application of LED device which is more advantageous in terms of cost and space gain in clinical practice of physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tooth Movement | Experimental | Device: Cheese dental laser, Device: OrthoPulse, Other: PlaceboCanine distalization on premolar extracted patients |
| Biochemistry measurements | Experimental | Device: Cheese dental laser, Device: OrthoPulse, Other: Placebobiochemistry analysis of IL-8, OPG, RANKL |
| periodontal measurements | Experimental | Device: Cheese dental laser, Device: OrthoPulse, Other: Placebogingival and plaque index, blooding on probing, pocket depth |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- adequate oral hygiene
- Class 2 malocclusion requiring upper-premolar extraction orthodontic treatment
- lack of congenital missing teeth in upper jaw
- no systemic disease
Key exclusion criteria (2 listed)
- patients who wish to discontinue treatment
- patients who cannot provide oral hygiene
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 |
|---|---|---|
| Cheese dental laser810 nm GaAlAs diode laser device | Device | Biochemistry measurements, Tooth Movement, periodontal measurements |
| OrthoPulse850 nm LED (light emitting diode) | Device | Biochemistry measurements, Tooth Movement, periodontal measurements |
| Placebo810 nm GaAlAs diode laser device | Other | Biochemistry measurements, Tooth Movement, periodontal measurements |
Primary outcome
Orthodontic tooth movement Change
Time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Measurement of orthodontic tooth movement (mm)
7 secondary outcomes
Gingival Index Change
Time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Plaque Index Change
Time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
RANKL Change
Time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
OPG Change
Time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
IL-8 Change
Time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Bleeding on Probing Change
Time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Periodontal Pocket Depth Change
Time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- 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.
Aslihan Karakas, MS contact
Hasan Gundogar, PhD study chair
Gaziantep University Periodontology Department
Seyithan Taysi, Prof study chair
Gaziantep University Biochemistry Department
Questions about this trial
What is this clinical trial studying?
A study testing Cheese dental laser and OrthoPulse in people with Orthodontic Tooth Movement, run by University of Gaziantep.
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 4 inclusion and 2 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 18 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?
Contact Merve Goymen, PhD (+905054767651, mervegoymen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthodontic tooth movement Change (time frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day). 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 18 Jul 2019.