Crowding of Anterior Mandibular TeethNCT06337435
Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding
An observational study of Crowding of Anterior Mandibular Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Crowding of Anterior Mandibular Teeth
- What is being tested?
- multi-looped wire
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 18 Jan 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with mild to moderate crowding
Who may be able to join
- 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.
Who cannot join
- Facial trauma, Oral habits such as onychophagia, pen biting, and tooth mobility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Crowding of Anterior Mandibular Teeth
- Being tested
- multi-looped wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-looped wireOther
using multi-looped wire as a retainer
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: follow-up three to six months
Secondary outcomes (1)
The stability of lower incisor positioning after ending treatment
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.
Measured: after 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Dec 2022
- Primary completion10 Jul 2023
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowding of Anterior Mandibular TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basel Mouafak Mohamed Alhawash, Cairo University
- Investigators
- bassel mouafak alhawash, master, Principal investigator, bassel.alhawash@dentistry.cu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337435
- Sponsor's protocol ID
- 8223
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of the Multi-Looped Lingual Retainer Activated by A New Method to Align Lower Incisor Crowding
- ClinicalTrials.gov ID
- NCT06337435
- Acronym / sponsor ID
- 8223
- Conditions
- Crowding of Anterior Mandibular Teeth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with mild to moderate crowding
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Facial trauma, Oral habits such as onychophagia, pen biting, and tooth mobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-looped wireusing multi-looped wire as a retainer | Other | – |
Primary outcome
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.
1 secondary outcome
The stability of lower incisor positioning after ending treatment
Time frame: after 1-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
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Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bassel mouafak alhawash, master principal investigator
bassel.alhawash@dentistry.cu.edu.eg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crowding of Anterior Mandibular Teeth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of lower incisors irregularity using Little Irregularity Index. (time frame: follow-up three to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.