NCT05465473

Brief Summary

study will be directed to evaluate the effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

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

December 12, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

July 8, 2022

Last Update Submit

July 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of molar distalization

    rate of distalization of the maxillary first molars will be evaluated using direct clinical assessment and cast analysis according to standardized methods.

    from start of treatment until study completion, an average of 1 year

Study Arms (2)

Group I

ACTIVE COMPARATOR

will include 10 patients undergo distalization according to a standardized protocol

Other: Distalization

Group II

ACTIVE COMPARATOR

will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol

Other: Distalization

Interventions

Group I: will include 10 patients undergo distalization according to a standardized protocol. Group II: will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol.

Group IGroup II

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • An age range from 14-17 years old. 2- All permanent teeth are present (except for third molars). 3- Bilateral dental Class II malocclusion. 4- Skeletal Class I or mild Class II relationship. 5- Normal or reduced vertical face height. 6- No posterior crowding or spaces.

You may not qualify if:

  • Patients who required surgery to correct skeletal discrepancies.
  • Patients with congenital dentoskeletal disorders.
  • Missed or mutilated teeth in maxillary arch.
  • Patients with poor oral hygiene and/or periodontally compromised patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Central Study Contacts

Ahmed T Hussein, doctoraa

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 19, 2022

Study Start

December 12, 2021

Primary Completion

August 12, 2022

Study Completion

December 12, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations