NCT06493721

Brief Summary

The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 29, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

June 29, 2024

Last Update Submit

July 9, 2024

Conditions

Crowding of Anterior Maxillary Teeth

Keywords

Clear aligner treatmentLow level laser therapyClear aligner therapyAccelerated orthodonticsorthodontic tooth movementupper incisor crowdingorthodontic pain

Outcome Measures

Primary Outcomes (1)

  • Rate of tooth movement

    Calculate rate of anterior incisor decrowding using digital measurement in millimetre

    Initial alignment at the end of 3rd month during treatment planning of clear aligner

Secondary Outcomes (1)

  • Pain level

    Initial alignment at the end of 3rd month phase during treatment planning of clear aligner

Study Arms (2)

Clear aligner only

EXPERIMENTAL

Clear aligner therapy group only

Procedure: Clear Aligner Treatment

Low level laser

EXPERIMENTAL

Clear aligner therapy with low level laser therapy

Procedure: Clear Aligner TreatmentProcedure: Low level laser

Interventions

Clear Aligner TreatmentPROCEDURE

Clear aligner therapy to treat incisors crowding

Clear aligner onlyLow level laser
Low level laserPROCEDURE

Apply clear aligner therapy with low level laser application on incisors

Low level laser

Eligibility Criteria

Age16 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients age ranging from 16-23 years old with Angle class I malocclusion and upper anterior crowding.
  • Healthy, compliant and internally motivated patient.
  • Full set of maxillary permanent dentition except third molar.

You may not qualify if:

  • Previous orthodontic treatment.
  • Any systemic diseases that could interfere with orthodontic treatment.
  • Gross gingival or periodontal problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine for Girls Al-Azhar University

Cairo, 11787, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Samir Abdo

    Faculty of Dental Medicine, Girls Branch, Al Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

June 29, 2024

First Posted

July 10, 2024

Study Start

December 15, 2022

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

EG(1)