Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement

Not Applicable

• Conditions: Orthodontic Appliance
• Interventions: Device: Miniscrew

• Registration Number: NCT05092633
• Lead Sponsor: Alexandria University

Brief Summary

EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT

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 Timeline

• Study Start: 2021-09-26
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-10-25
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-17
• Primary Completion: 2022-04-07
• Study Completion: 2022-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Miniscrew	Will have miniscrew only without laser application
Experimental	Miniscrew	Will have miniscrew and laser application

Primary Outcome Measures

Name	Time	Method
effect of low level laser therapy on displacement of miniscrews	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

Name	Time	Method
effect of LLL application on gingival condition around the miniscrew.	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).

Trial Locations

Locations (2)

Alexandria University; 🇪🇬 Alexandria, Egypt

AlexandriaU; 🇪🇬 Alexandria, Egypt