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Completed

NCT Number: NCT06024382

The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients

this is a controlled clinical trial with 2 groups of patients of class II skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes, rate of correction and pain during treatment

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Key information

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age (early permanent dentition)
  • Cervical maturation stage CS 3-4
  • Skeletal class II due to mandibular retrusion.
  • Overjet more than 4mm.

Exclusion criteria

  • Cleft lip or palate.
  • Systemic diseases.
  • Previous orthodontic treatment or abnormal habits.
  • Congenital craniofacial deformity.
  • poor oral hygiene

Treatment and study plan

twin block

Other

2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy

twin block combined with low level laser

Other

2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy

Primary outcomes

  1. treatment time

    Time frame: 8 months

    comparison of treatment between the 2 different groups

Secondary outcomes

  1. cephalometric measurements

    Time frame: 8 months

    digital tracing of pre and post treatment cephalograms of both groups and comparison of linear and angular measurements

  2. study cast analysis

    Time frame: 8 months

    cast analysis of both groups measuring arch perimeter , intercanine wisth and intermolar width

  3. the short form McGill pain questionnaire

    Time frame: 1 month

    comparison of questionnaire results between the 2 groups

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 6, 2023
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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