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

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ClinicalTrials.gov Identifier: NCT05092633
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Elzoheiry, Alexandria University

Brief Summary:
EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT

Condition or disease Intervention/treatment Phase
Orthodontic Appliance Device: Miniscrew Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement
Actual Study Start Date : September 26, 2021
Estimated Primary Completion Date : April 7, 2022
Estimated Study Completion Date : May 5, 2022

Arm Intervention/treatment
Experimental: Control
Will have miniscrew only without laser application
Device: Miniscrew
Application of laser on miniscrew
Other Name: Laser

Experimental: Experimental
Will have miniscrew and laser application
Device: Miniscrew
Application of laser on miniscrew
Other Name: Laser




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).




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Ages Eligible for Study:   18 Years to 22 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05092633


Contacts
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Contact: Mohamed A Elzoheiry 01007036198 dr.melzoheiry@gmail.com
Contact: Mohamed A Elzoheiry 01064705192 dr.melzoheiry@gmail.com

Locations
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Egypt
Alexandria University Recruiting
Alexandria, Egypt
Contact: Mohamed A Elzoheiry    01007036198    dr.melzoheiry@gmail.com   
AlexandriaU Recruiting
Alexandria, Egypt
Contact: Mohamed Elzoheiry    01007036198    Dr.melzoheiry@gmail.com   
Sponsors and Collaborators
Alexandria University
Investigators
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Study Director: Mohamed A Elzoheiry Alexandria University
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Responsible Party: Mohamed Elzoheiry, Principal investigator, Alexandria University
ClinicalTrials.gov Identifier: NCT05092633    
Other Study ID Numbers: Effect of laser on mini screw
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Elzoheiry, Alexandria University:
Miniscrew