Clinical trial NCT02891499: Influence of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants
Official title: Effect of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants With Mediate and Immediate Force Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Resonance frequency analysis
Orthodontic
Orthodontic miniscrew implant
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 29
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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%.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline miniscrew implant stability at 1 and 3 months of force application.
timeFrame: T1: Implantation day; T2: after 1 month; and, T3: after 3 months of force application.
measure: Change from baseline miniscrew implant position at 3 months of force application.
timeFrame: CT1: Implantation day; and, CT2: 3 months of orthodontic force application.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Guido A Marañón Vásquez, DDS
role: PRINCIPAL_INVESTIGATOR
References: