Displacement of Other Bone Devices, Implants and GraftsNCT02891499
Influence of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants
A study testing Low-level laser therapy and Mediate force application in people with Displacement of Other Bone Devices, Implants and Grafts and Mechanical Complication of Other Bone Devices, Implants and Grafts, run by University of Sao Paulo.
Trial summary
The purpose of this study is to evaluate the effect of Low level laser therapy on stability and displacement of orthodontic miniscrew implants using two different force application protocols. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Displacement of Other Bone Devices, Implants and Grafts, Mechanical Complication of Other Bone Devices, Implants and Grafts
- What is being tested?
- Low-level laser therapy and Mediate force application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Aug 2017
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient with permanent teeth.
- Use of miniscrews in orthodontic planning.
- Miniscrews placed in the labial upper and lower posterior regions.
- Patient who agree to participate (Informed consent)
Who cannot join
- Patient with systemic disease.
- Patient with periodontal disease and/or inadequate oral hygiene.
- Use of drugs chronically.
- Patients that consume alcohol or tobacco.
- Use of fixed palatal or lingual orthodontic devices.
About this study
Official title: Effect of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants With Mediate and Immediate Force Application
The purpose of this study is to evaluate the effect of Low level laser therapy on stability and displacement of orthodontic miniscrew implants using two different force application protocols.
Read the detailed description
The aim of this study is to evaluate the effect of Low level laser therapy (LLLT) on stability and displacement of orthodontic miniscrew implants with mediate and immediate force application. They will be assessed 48 miniscrew implants placed in patients in orthodontic treatment at the postgraduate clinical in Orthodontics, at School of Dentistry of Ribeirão Preto, University of São Paulo. They will be randomly divided into 4 groups: 1- LLLT and immediate force application; 2- LLLT and force application 4 weeks after implantation; 3- immediate force application without LLLT and 4- force application 4 weeks after implantation without LLLT. Orthodontic force of 150 gF will be applied for 3 months. A low power laser device Therapy XT with a wavelength of 660 nm and output of 100 mW immediately after implantation (energy density: 4J/cm2), and 808 nm with 100 mW (energy density: 8J/cm2), every 48 hours for two weeks in the following applications will be used. The stability will be assessed using Resonance Frequency Analysis (RFA) at three times: the implantation day (T1), one month (T2) and after 3 months of force application (T3). Stability measures will be evaluated in Implant Stability Quotient (ISQ). To assess the amount of miniscrew implant displacement, it will be used Cone Beam Computed Tomography (CBCT) at the beginning (CT1) and final of the application of orthodontic force (CT2). Three-dimensional models will be created in specific programs and superimpositions of CT1 and CT2 will be used to measure the distance in millimeters between inicial and final position. The evaluation will be carried out in three points: head of miniscrew implant (point C), thread (point R) and apex of miniscrew implant (point A). The results will be statistically analyzed according to nature of the data and the significance level to be adopted will be 5%.
- Conditions
- Displacement of Other Bone Devices, Implants and Grafts, Mechanical Complication of Other Bone Devices, Implants and Grafts
- Being tested
- Low-level laser therapy, Mediate force application
- Keywords
- Miniscrews, Mini-implants, Temporal anchorage devices, Bone screws, Stability, Displacement, Low-level laser therapy, Cone-beam computed tomography, Resonance frequency analysis, Orthodontic, Orthodontic miniscrew implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyProcedure or surgery
- Immediate post-operative period (implantation day) Red emission (660 nm) Energy density: 4 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 One application, 10 seconds of non-contact irradiation (01 point at the area surrounding the miniscrew) at a distance of 15,5 mm.
- Mediate post-operative period (after implantation day) Infrared emission (808 nm) Energy density: 8 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 6 applications every 48 hours after the day of implantation, 20 seconds of non-contact irradiation (01 point on the area surrounding the miniscrew) at a distance of 15,5 mm.
Mediate force applicationProcedure or surgery
Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.
| Study group | Role | What they receive |
|---|---|---|
| LLLT + immediate force | Experimental | Use of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation). Receives: Procedure: Low-level laser therapy |
| LLLT + mediate force | Experimental | Use of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation). Receives: Procedure: Low-level laser therapy; Procedure: Mediate force application |
| Immediate force application | No intervention | Not mediate orthodontic force application (150 gF the day of the implantation), without use of Low-level laser therapy. |
| Mediate force application | Experimental | Mediate orthodontic force application (150 gF 4 weeks after the day of the implantation), without use of Low-level laser therapy. Receives: Procedure: Mediate force application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline miniscrew implant stability at 1 and 3 months of force application.
It will be used a Resonance frequency analysis (RFA) equipment. Stability measures will be evaluated using a unique unit of measure: Implant stability quotient (ISQ). All groups will be evaluated the day of the implantation (T1) and after 1 month (T2).The last stability measure (T3) will be done 3 months after the implantation day in the groups without mediate force application, and 4 months after the implantation day in the groups with mediate force application.
Measured: T1: Implantation day; T2: after 1 month; and, T3: after 3 months of force application.
Change from baseline miniscrew implant position at 3 months of force application.
It will be used Cone Beam Computed tomography (CBCT). Three-dimensional models will be created in specific programs and superimpositions of CT1 and CT2 will be used to measure the distance in millimeters between initial and final position.
Measured: CT1: Implantation day; and, CT2: 3 months of orthodontic force application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Displacement of Other Bone Devices, Implants and GraftsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Artemio Marañón Vásquez, University of Sao Paulo
- Investigators
- Guido A Marañón Vásquez, DDS, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891499
- Sponsor's protocol ID
- USaoPaulo-1
- Status last verified
- Jan 2018
- First submitted
- 23 Aug 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants With Mediate and Immediate Force Application
- ClinicalTrials.gov ID
- NCT02891499
- Acronym / sponsor ID
- USaoPaulo-1
- Conditions
- Displacement of Other Bone Devices, Implants and Grafts, Mechanical Complication of Other Bone Devices, Implants and Grafts
- Keywords
- Miniscrews, Mini-implants, Temporal anchorage devices, Bone screws, Stability, Displacement, Low-level laser therapy, Cone-beam computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 7 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.
The purpose of this study is to evaluate the effect of Low level laser therapy on stability and displacement of orthodontic miniscrew implants using two different force application protocols.
Detailed description
The aim of this study is to evaluate the effect of Low level laser therapy (LLLT) on stability and displacement of orthodontic miniscrew implants with mediate and immediate force application. They will be assessed 48 miniscrew implants placed in patients in orthodontic treatment at the postgraduate clinical in Orthodontics, at School of Dentistry of Ribeirão Preto, University of São Paulo. They will be randomly divided into 4 groups: 1- LLLT and immediate force application; 2- LLLT and force application 4 weeks after implantation; 3- immediate force application without LLLT and 4- force application 4 weeks after implantation without LLLT. Orthodontic force of 150 gF will be applied for 3 months. A low power laser device Therapy XT with a wavelength of 660 nm and output of 100 mW immediately after implantation (energy density: 4J/cm2), and 808 nm with 100 mW (energy density: 8J/cm2), every 48 hours for two weeks in the following applications will be used. The stability will be assessed using Resonance Frequency Analysis (RFA) at three times: the implantation day (T1), one month (T2) and after 3 months of force application (T3). Stability measures will be evaluated in Implant Stability Quotient (ISQ). To assess the amount of miniscrew implant displacement, it will be used Cone Beam Computed Tomography (CBCT) at the beginning (CT1) and final of the application of orthodontic force (CT2). Three-dimensional models will be created in specific programs and superimpositions of CT1 and CT2 will be used to measure the distance in millimeters between inicial and final position. The evaluation will be carried out in three points: head of miniscrew implant (point C), thread (point R) and apex of miniscrew implant (point A). The results will be statistically analyzed according to nature of the data and the significance level to be adopted will be 5%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LLLT + immediate force | Experimental | Procedure: Low-level laser therapyUse of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation). |
| LLLT + mediate force | Experimental | Procedure: Low-level laser therapy, Procedure: Mediate force applicationUse of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation). |
| Immediate force application | No intervention | –Not mediate orthodontic force application (150 gF the day of the implantation), without use of Low-level laser therapy. |
| Mediate force application | Experimental | Procedure: Mediate force applicationMediate orthodontic force application (150 gF 4 weeks after the day of the implantation), without use of Low-level laser therapy. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with permanent teeth.
- Use of miniscrews in orthodontic planning.
- Miniscrews placed in the labial upper and lower posterior regions.
- Patient who agree to participate (Informed consent)
Key exclusion criteria (5 listed)
- Patient with systemic disease.
- Patient with periodontal disease and/or inadequate oral hygiene.
- Use of drugs chronically.
- Patients that consume alcohol or tobacco.
- Use of fixed palatal or lingual orthodontic devices.
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 |
|---|---|---|
| Low-level laser therapy1. Immediate post-operative period (implantation day) Red emission (660 nm) Energy density: 4 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 One application, 10 seconds of non-contact irradiation (01 point at the area surrounding the miniscrew) at a distance of 15,5 mm. 2. Mediate post-operative period (after implantation day) Infrared emission (808 nm) Energy density: 8 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 6 applications every 48 hours after the day of implantation, 20 seconds of non-contact irradiation (01 point on the area surrounding the miniscrew) at a distance of 15,5 mm. | Procedure or surgery | LLLT + immediate force, LLLT + mediate force |
| Mediate force applicationMediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation. | Procedure or surgery | LLLT + mediate force, Mediate force application |
Primary outcome
Change from baseline miniscrew implant stability at 1 and 3 months of force application.
Time frame: T1: Implantation day; T2: after 1 month; and, T3: after 3 months of force application.
It will be used a Resonance frequency analysis (RFA) equipment. Stability measures will be evaluated using a unique unit of measure: Implant stability quotient (ISQ). All groups will be evaluated the day of the implantation (T1) and after 1 month (T2).The last stability measure (T3) will be done 3 months after the implantation day in the groups without mediate force application, and 4 months after the implantation day in the groups with mediate force application.
Change from baseline miniscrew implant position at 3 months of force application.
Time frame: CT1: Implantation day; and, CT2: 3 months of orthodontic force application.
It will be used Cone Beam Computed tomography (CBCT). Three-dimensional models will be created in specific programs and superimpositions of CT1 and CT2 will be used to measure the distance in millimeters between initial and final position.
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 18 Jan 2018.
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.
Guido A Marañón Vásquez, DDS principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy and Mediate force application in people with Displacement of Other Bone Devices, Implants and Grafts and Mechanical Complication of Other Bone Devices, Implants and Grafts, 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 4 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: finished, as of the sponsor's last update on 18 Jan 2018. 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?
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?
Change from baseline miniscrew implant stability at 1 and 3 months of force application. (time frame: T1: Implantation day; T2: after 1 month; and, T3: after 3 months of force application.). 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 18 Jan 2018.