Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement

Orthodontic Appliance Clinical Trial

— Miniscrew  

Official title:

Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092633
• Other study ID #: Effect of laser on mini screw
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2021
• Est. completion date: May 5, 2022

Study information

• Verified date: November 2021
• Source: Alexandria University
• Contact: Mohamed A Elzoheiry
• Phone: 01007036198
• Email: dr.melzoheiry[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 5, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Appliance

Intervention

Device:
• Miniscrew
Application of laser on miniscrew

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria
Egypt	AlexandriaU	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of low level laser therapy on displacement of miniscrews	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	effect of LLL application on gingival condition around the miniscrew.	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