NCT06024382

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

August 23, 2023

Last Update Submit

March 11, 2024

Conditions

Class II Malocclusion

Keywords

twin block , functional appliance , low level laser , photobiomodulation

Outcome Measures

Primary Outcomes (1)

  • treatment time

    comparison of treatment between the 2 different groups

    8 months

Secondary Outcomes (3)

  • cephalometric measurements

    8 months

  • study cast analysis

    8 months

  • the short form McGill pain questionnaire

    1 month

Study Arms (2)

twin block

EXPERIMENTAL

group treated with twin block only

Other: twin block

twin block combined with low level laser

EXPERIMENTAL

group treated with twin block combined with low level laser therapy

Other: twin block combined with low level laser

Interventions

twin blockOTHER

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
twin block combined with low level laserOTHER

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

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 6, 2023

Study Start

October 26, 2022

Primary Completion

December 30, 2023

Study Completion

February 28, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)