Orthodontic Pathological Resorption of External RootNCT04044989
Photobiomodulation and Root Resorption
A study testing Laser and light-emitting diode (LED) in people with Orthodontic Pathological Resorption of External Root and Orthodontic Appliance Complication, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Objectives: The aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. Materials and Methods: 30 patients, who were admitted to the …………. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pathological Resorption of External Root, Orthodontic Appliance Complication, Orthodontic Tooth Movement
- What is being tested?
- Laser and light-emitting diode (LED)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2018to 13 Dec 2018
- 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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No history of orthodontic treatment
- No systemic disease or craniofacial anomaly
- No dental trauma and tooth with root resorption
- Having good oral hygiene
- No periodontal disease (no more than 3mm pocket)
- No restored or endodontically untreated upper right 1st premolar teeth
- Having the maxillary right 1st premolar tooth extraction indication of orthodontic treatment
Who cannot join
- Problems in patient compliance
- Inadequate oral hygiene
- Development of any medical problem making orthodontic treatment contraindicated during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-Controlled, Randomized, Double Blind Trial of Effect of Photobiomodulation Therapies On The Root Resorption Associated With Orthodontic Forces: A Pilot Study Using Micro Computed Tomography
Objectives: The aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. Materials and Methods: 30 patients, who were admitted to the …………. University Faculty of Dentistry Orthodontics Department for treatment, with an indication of upper right 1st premolar tooth extraction was included. Before the individuals' orthodontic treatment, 0.022 slot MBT brackets and tubes were placed on the maxillary 1st premolar and molar. A 150g buccal tipping force was applied to the 1st premolar. Individuals were then randomly divided into 3 groups. For the first group; laser application was performed with a 810 nm GaAlAs laser device at 0,3,7,14,21 and 28 days to 8 J/cm2. Second group; an LED application according to the manufacturer's instructions with a 850 nm wavelength and 20 mW/cm2 output power for 10 minutes per day during the experiment. Third group; a placebo therapy was completed whereby a laser device that did not make active pulses was used. At the end of four weeks, the amount of root surface resorption was compared using micro-CT imaging after the extraction of the teeth.
- Conditions
- Orthodontic Pathological Resorption of External Root, Orthodontic Appliance Complication, Orthodontic Tooth Movement
- Being tested
- Laser, light-emitting diode (LED), Placebo
- Keywords
- photobiomodulation, laser, LED, resorption, micro-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Diode laser device was used for photobiomodulation
light-emitting diode (LED)Device
LED device was used for photobiomodulation
PlaceboDevice
Diode laser device was used for placebo effect
| Study group | Role | What they receive |
|---|---|---|
| Root resorption (total) | Experimental | The resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT). Receives: Device: Laser; Device: light-emitting diode (LED); Device: Placebo |
| Root resorption (local) | Experimental | The resorption cavities on the root surface (palatal, buccal, distal and mesial root surfaces) were determined and the volumes of the cavities were measured in CTAn software (micro-CT). Receives: Device: Laser; Device: light-emitting diode (LED); Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Resorption
Crater volume measurement
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start10 Jan 2018
- Primary completion5 Jun 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Pathological Resorption of External RootStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Goymen, University of Gaziantep
- Investigators
- Aysegul Gulec, PhD, Principal investigator, Gaziantep University Orthodontics DepartmentMerve Goymen, PhD, Study chair, Gaziantep University Orthodontics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044989
- Sponsor's protocol ID
- 332
- Status last verified
- Aug 2019
- First submitted
- 29 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Randomized, Double Blind Trial of Effect of Photobiomodulation Therapies On The Root Resorption Associated With Orthodontic Forces: A Pilot Study Using Micro Computed Tomography
- ClinicalTrials.gov ID
- NCT04044989
- Acronym / sponsor ID
- 332
- Conditions
- Orthodontic Pathological Resorption of External Root, Orthodontic Appliance Complication, Orthodontic Tooth Movement
- Keywords
- photobiomodulation, laser, LED, resorption, micro-CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 5 Aug 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.
Objectives: The aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. Materials and Methods: 30 patients, who were admitted to the …………. University Faculty of Dentistry Orthodontics Department for treatment, with an indication of upper right 1st premolar tooth extraction was included. Before the individuals' orthodontic treatment, 0.022 slot MBT brackets and tubes were placed on the maxillary 1st premolar and molar. A 150g buccal tipping force was applied to the 1st premolar. Individuals were then randomly divided into 3 groups. For the first group; laser application was performed with a 810 nm GaAlAs laser device at 0,3,7,14,21 and 28 days to 8 J/cm2. Second group; an LED application according to the manufacturer's instructions with a 850 nm wavelength and 20 mW/cm2 output power for 10 minutes per day during the experiment. Third group; a placebo therapy was completed whereby a laser device that did not make active pulses was used. At the end of four weeks, the amount of root surface resorption was compared using micro-CT imaging after the extraction of the teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root resorption (total) | Experimental | Device: Laser, Device: light-emitting diode (LED), Device: PlaceboThe resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT). |
| Root resorption (local) | Experimental | Device: Laser, Device: light-emitting diode (LED), Device: PlaceboThe resorption cavities on the root surface (palatal, buccal, distal and mesial root surfaces) were determined and the volumes of the cavities were measured in CTAn software (micro-CT). |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- No history of orthodontic treatment
- No systemic disease or craniofacial anomaly
- No dental trauma and tooth with root resorption
- Having good oral hygiene
- No periodontal disease (no more than 3mm pocket)
Key exclusion criteria (3 listed)
- Problems in patient compliance
- Inadequate oral hygiene
- Development of any medical problem making orthodontic treatment contraindicated during the study period
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 |
|---|---|---|
| LaserDiode laser device was used for photobiomodulation | Device | Root resorption (local), Root resorption (total) |
| light-emitting diode (LED)LED device was used for photobiomodulation | Device | Root resorption (local), Root resorption (total) |
| PlaceboDiode laser device was used for placebo effect | Device | Root resorption (local), Root resorption (total) |
Primary outcome
Root Resorption
Time frame: through study completion, an average of 4 weeks
Crater volume measurement
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 5 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Orthodontic Pathological Resorption of External Root
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Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems
Orthodentic Appliances, Orthodontic Pathological Resorption of External Root
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.
Aysegul Gulec, PhD principal investigator
Gaziantep University Orthodontics Department
Merve Goymen, PhD study chair
Gaziantep University Orthodontics Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and light-emitting diode (LED) in people with Orthodontic Pathological Resorption of External Root and Orthodontic Appliance Complication, run by University of Gaziantep 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 3 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 5 Aug 2019. 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?
Root Resorption (time frame: through study completion, an average of 4 weeks). 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 5 Aug 2019.