Influence of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants

NCT ID: NCT02891499

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-08-31

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%.

Conditions

Displacement of Other Bone Devices, Implants and Grafts; Mechanical Complication of Other Bone Devices, Implants and Grafts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

LLLT + immediate force

Use of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation).

Group Type: EXPERIMENTAL

Low-level laser therapy

Intervention Type: PROCEDURE

1. 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.

LLLT + mediate force

Use of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation).

Group Type: EXPERIMENTAL

Low-level laser therapy

Intervention Type: PROCEDURE

1. 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.

Mediate force application

Intervention Type: PROCEDURE

Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.

Immediate force application

Not mediate orthodontic force application (150 gF the day of the implantation), without use of Low-level laser therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mediate force application

Mediate orthodontic force application (150 gF 4 weeks after the day of the implantation), without use of Low-level laser therapy.

Group Type: EXPERIMENTAL

Mediate force application

Intervention Type: PROCEDURE

Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.

Interventions

Low-level laser therapy

1. 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.

Intervention Type: PROCEDURE

Mediate force application

Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Guido Artemio Marañón Vásquez

Master of science student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guido A Marañón Vásquez, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Other Identifiers

USaoPaulo-1

Identifier Type: -

Identifier Source: org_study_id