NCT06337435

Brief Summary

this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 15, 2024

Last Update Submit

March 22, 2024

Conditions

Crowding of Anterior Mandibular Teeth

Outcome Measures

Primary Outcomes (1)

  • The improvement of lower incisors irregularity using Little Irregularity Index.

    using multi-looped for relief crowding, the digital model analysis will be used to calculate the amount of irregularity by using Little Irregularity Index .the measurement will be done on 3-shape software.

    follow-up three to six months

Secondary Outcomes (1)

  • The stability of lower incisor positioning after ending treatment

    after 1-3 months

Interventions

multi-looped wireOTHER

using multi-looped wire as a retainer

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients with mild to moderate crowding

You may qualify if:

  • Adult male and female patients, the ages of 16 to 25, the patients having class I canine with mild to moderate lower incisors crowding
  • good oral hygiene.

You may not qualify if:

  • Facial trauma, Oral habits such as onychophagia, pen biting, and tooth mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry Cairo university

Cairo, Egypt

Location

Study Officials

  • bassel mouafak alhawash, master

    bassel.alhawash@dentistry.cu.edu.eg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master degree faculty Cairo university

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 29, 2024

Study Start

December 15, 2022

Primary Completion

July 10, 2023

Study Completion

January 18, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations

EG(1)