- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06337435
Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding
March 22, 2024 updated by: Basel Mouafak Mohamed Alhawash, Cairo University
The Ability of the Multi-Looped Lingual Retainer Activated by A New Method to Align Lower Incisor Crowding
this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- patients preparation( photo- impression- x-ray- scan the lower cast to calculate the crowding )
- The multi-looped lingual retainer was fabricated on the patient's lower cast
- The lingual surfaces of teeth were etched with 35% phosphoric acid for 20 seconds The multi-looped lingual retainer was activated in the new way (Kattan method ) by tightening a steel ligature wire 0.010 inches, to the reinforcement 0.020-inch stainless steel arch-wire.
- the bonding agent was applied on such surfaces after a good isolation and was light-cured for 20 seconds.
- A flowable composite resin was applied. After checking its fit on the surface of the teeth, The lingual wire was bonded with a drop of flowable composite resin and was light-cured for 20 seconds.
- follow-up the patients * Outcomes: The improvement of lower incisors irregularity using Little Irregularity Index.
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- Faculty of Dentistry Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
patients with mild to moderate crowding
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Facial trauma, Oral habits such as onychophagia, pen biting, and tooth mobility.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The improvement of lower incisors irregularity using Little Irregularity Index.
Time Frame: follow-up three to six months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The stability of lower incisor positioning after ending treatment
Time Frame: after 1-3 months
|
using multi-looped as a retainer for stability to prevent the relapse after end treatment and the amount of lower incisor irregularity will be evaluated on scanned post-treatment digital models and measured on the 3-shape software.
|
after 1-3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: bassel mouafak alhawash, master, bassel.alhawash@dentistry.cu.edu.eg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2022
Primary Completion (Actual)
July 10, 2023
Study Completion (Actual)
January 18, 2024
Study Registration Dates
First Submitted
March 15, 2024
First Submitted That Met QC Criteria
March 22, 2024
First Posted (Actual)
March 29, 2024
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 8223
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Crowding of Anterior Mandibular Teeth
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