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

17 januari 2018 uppdaterad av: Guido Artemio Marañón Vásquez, University of Sao Paulo

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.

Studieöversikt

Detaljerad beskrivning

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%.

Studietyp

Interventionell

Inskrivning (Faktisk)

29

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

11 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: LLLT + immediate force
Use of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation).
  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.
Experimentell: LLLT + mediate force
Use of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation).
  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 protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.
Inget ingripande: Immediate force application
Not mediate orthodontic force application (150 gF the day of the implantation), without use of Low-level laser therapy.
Experimentell: Mediate force application
Mediate orthodontic force application (150 gF 4 weeks after the day of the implantation), without use of Low-level laser therapy.
Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline miniscrew implant stability at 1 and 3 months of force application.
Tidsram: 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.
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.
Tidsram: 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.
CT1: Implantation day; and, CT2: 3 months of orthodontic force application.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Guido A Marañón Vásquez, DDS, University of Sao Paulo

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2016

Primärt slutförande (Faktisk)

1 februari 2017

Avslutad studie (Faktisk)

1 augusti 2017

Studieregistreringsdatum

Först inskickad

23 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

31 augusti 2016

Första postat (Uppskatta)

7 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 januari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 januari 2018

Senast verifierad

1 januari 2018

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Low-level laser therapy

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