Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement (Miniscrew)

November 9, 2021 updated by: Mohamed Elzoheiry, Alexandria University
EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Miniscrews can achieve good anchorage for different types of tooth movements, as intrusion, retraction, and protraction. However, obtaining primary stability is a challenge in their clinical application.Low Level Laser Therapy is suggested to prevent miniscrew displacement. Also previous studies concluded that Low Level Laser Therapy has an effect in stabilizing miniscrew after direct application.

So the aim of this study is to assess the effect of Low Level Laser Therapy on displacement of miniscrews during canine retraction.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria University
        • Contact:
      • Alexandria, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 22 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 to 22 years old.
  • Permanent dentition.
  • Class I Bimaxillary protrusion and class II devision 1 patients.
  • Good oral hygiene.

Exclusion Criteria:

  • Medically compromised patients.
  • Chronic renal failure and hormonal disorders as thyroid and parathyroid.
  • Regular use of steroids, barbiturates, anticonvulsants drugs, and thyroid hormone replacements.
  • Tobacco smoking.
  • Any disease or metabolic disorder that can affect bone physiology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Control
Will have miniscrew only without laser application
Device: Miniscrew
Application of laser on miniscrew
Other Names:
  • Laser
EXPERIMENTAL: Experimental
Will have miniscrew and laser application
Device: Miniscrew
Application of laser on miniscrew
Other Names:
  • Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of low level laser therapy on displacement of miniscrews
Time Frame: 4 months
Miniscrews displacement will be assessed after four months of canine retraction using CBCT scan. The head and tail of miniscrew will be measured in relation to anterior nasal spine as a fixed reference point before and after retraction
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of LLL application on gingival condition around the miniscrew.
Time Frame: 4 months

Gingival inflammation around miniscrew head will evaluated just after placement and at day 7 and 14 before application of retraction force and during days 21, 30, 60 which will be during the period of force application, based on modified gingival index with scores range from 0 to 3 as follows:Score 0 - no signs of inflammation (tissue around head is pink in color).

Score 1 - mild inflammation (tissues are red in color, no bleeding sign). Score 2 - moderate inflammation (tissues are intense red in color, small bleeding signs).

Score 3- severe inflammation (bleeding, evidence of swelling).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Director: Mohamed A Elzoheiry, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 26, 2021

Primary Completion (ANTICIPATED)

April 7, 2022

Study Completion (ANTICIPATED)

May 5, 2022

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (ACTUAL)

October 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Effect of laser on mini screw

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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