NCT05092633

Brief Summary

EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

September 27, 2021

Last Update Submit

November 9, 2021

Conditions

Orthodontic Appliance

Keywords

Miniscrew

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • effect of LLL application on gingival condition around the miniscrew.

    4 months

Study Arms (2)

Control

EXPERIMENTAL

Will have miniscrew only without laser application

Device: Miniscrew

Experimental

EXPERIMENTAL

Will have miniscrew and laser application

Device: Miniscrew

Interventions

MiniscrewDEVICE

Application of laser on miniscrew

Also known as: Laser
ControlExperimental

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alexandria University

Alexandria, Egypt

RECRUITING

AlexandriaU

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Mohamed A Elzoheiry

    Alexandria University

    STUDY DIRECTOR

Central Study Contacts

Mohamed A Elzoheiry

CONTACT

01007036198dr.melzoheiry@gmail.com

Mohamed A Elzoheiry

CONTACT

01064705192dr.melzoheiry@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 25, 2021

Study Start

September 26, 2021

Primary Completion

April 7, 2022

Study Completion

May 5, 2022

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations

EG(2)