Overview

This trial is active, not recruiting.

Conditions displacement of other bone devices, implants and grafts, mechanical complication of other bone devices, implants and grafts
Treatments low-level laser therapy, mediate force application
Sponsor University of Sao Paulo
Start date March 2016
End date November 2016
Trial size 21 participants
Trial identifier NCT02891499, USaoPaulo-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Use of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation).
low-level laser therapy
Immediate post-operative period (implantation day) Red emission (650 nm) Energy density: 2 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: 4 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.
(Experimental)
Use of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation).
low-level laser therapy
Immediate post-operative period (implantation day) Red emission (650 nm) Energy density: 2 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: 4 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 application
Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.
(No Intervention)
Not mediate orthodontic force application (150 gF the day of the implantation), without use of Low-level laser therapy.
(Experimental)
Mediate orthodontic force application (150 gF 4 weeks after the day of the implantation), without use of Low-level laser therapy.
mediate force application
Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.

Primary Outcomes

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.
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.

Eligibility Criteria

Male or female participants at least 12 years old.

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.

Additional Information

Official title Effect of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants With Mediate and Immediate Force Application
Principal investigator Guido A Marañón Vásquez, DDS
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 650 nm and output of 100 mW immediately after implantation (energy density: 2J/cm2), and 808 nm with 100 mW (energy density: 4J/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 to compare the distance in millimeters of reference planes in the maxilla and mandible to the mini-implant in CT1 and CT2. 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%.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.