Percentage of Deep Bite CorrectionNCT06677619
Assessment of Changes in Labioincisal Relationship in Deep Bite Correction by Twin Slot Orthodontic Bracket Clinical Trial Study.
A study testing intrusion by reverse curve wire in cervical position of twin slot bracket in people with Percentage of Deep Bite Correction, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Assessment Changes in Labio incisal Relationship in Deep bite Correction by Twin Slot Orthodontic Bracket; clinical trial study. Read more about this study
- Who is it for?
- Ages 16 to 23 years, women only
- Conditions the study is for
- Percentage of Deep Bite Correction
- What is being tested?
- intrusion by reverse curve wire in cervical position of twin slot bracket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2022to 10 Sep 2024
- Phase
- Interventional
- 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 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- • Mild to moderate deep bite.
- Permanent dentition stage (excluding the third molar)
- Age ranges from 16-23 years.
- Free from any medical or systemic condition that could interfere with
- Orthodontic treatment plane or effect on procedures. Angle class1 or class11 malocclusion with minimal crowding.
- Female patient to avoide any sexual dimorphism which may affect the comparison.
- Good oral hygiene.
- No previous orthodontic treatment.
Who cannot join
- Uncooperative patient.
- Frequent missing appointments.
- Frequent broken appliance.
- Previous orthodontic treatments.
- Any systemic or bone diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Assessment Changes in Labio incisal Relationship in Deep bite Correction by Twin Slot Orthodontic Bracket; clinical trial study.
Read the detailed description
Group(A): patients will be treated with double slot bracket with wire in incisal slot Group(B):patients will be treated with double slot bracket with wire in cervical slot
- Conditions
- Percentage of Deep Bite Correction
- Being tested
- intrusion by reverse curve wire in cervical position of twin slot bracket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrusion by reverse curve wire in cervical position of twin slot bracketDevice
intrusion of anterior teeth by putting reverse curve wire in incisal slot of twin slot bracket
| Study group | Role | What they receive |
|---|---|---|
| intrusion by reverse curve in cervical position | Experimental | double slot bracket with reverse curvein cervical slot Receives: Device: intrusion by reverse curve wire in cervical position of twin slot bracket |
| intrusion with reverse curve in incisal position | Experimental | double slot bracket reverse curvein incisal slot Receives: Device: intrusion by reverse curve wire in cervical position of twin slot bracket |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of smile Line ,smile arch, upper lip line , buccal corridor and amount of intrusion of maxillary incisor
standerized extra oral photograph and lateral cephalometric
Measured: 1year
Secondary outcomes (1)
percentage of deep bite correction
orthodontic study cast and lateral cephalometric
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start10 Dec 2022
- Primary completion10 Aug 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percentage of Deep Bite CorrectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hend mohamed Abdelhalem Hegazy, Faculty of Dental Medicine for Girls
- Investigators
- Samir A Ibrahem, proffesor, Principal investigator, Professor of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677619
- Sponsor's protocol ID
- ORTHO-109-2-L
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Zoubi EM, Al-Nimri KS. A comparative study between the effect of reverse curve of Spee archwires and anterior bite turbos in the treatment of deep overbite cases. Angle Orthod. 2022 Jan 1;92(1):36-44. doi: 10.2319/020921-117.1.
PubMed 34329389
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Changes in Labioincisal Relationship in Deep Bite Correction by Twin Slot Orthodontic Bracket Clinical Trial Study.
- ClinicalTrials.gov ID
- NCT06677619
- Acronym / sponsor ID
- ORTHO-109-2-L
- Conditions
- Percentage of Deep Bite Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 7 Nov 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.
Assessment Changes in Labio incisal Relationship in Deep bite Correction by Twin Slot Orthodontic Bracket; clinical trial study.
Detailed description
Group(A): patients will be treated with double slot bracket with wire in incisal slot Group(B):patients will be treated with double slot bracket with wire in cervical slot
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrusion by reverse curve in cervical position | Experimental | Device: intrusion by reverse curve wire in cervical position of twin slot bracketdouble slot bracket with reverse curvein cervical slot |
| intrusion with reverse curve in incisal position | Experimental | Device: intrusion by reverse curve wire in cervical position of twin slot bracketdouble slot bracket reverse curvein incisal slot |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- • Mild to moderate deep bite.
Key exclusion criteria (5 listed)
- Uncooperative patient.
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 |
|---|---|---|
| intrusion by reverse curve wire in cervical position of twin slot bracketintrusion of anterior teeth by putting reverse curve wire in incisal slot of twin slot bracket | Device | intrusion by reverse curve in cervical position, intrusion with reverse curve in incisal position |
Primary outcome
assessment of smile Line ,smile arch, upper lip line , buccal corridor and amount of intrusion of maxillary incisor
Time frame: 1year
standerized extra oral photograph and lateral cephalometric
1 secondary outcome
percentage of deep bite correction
Time frame: 1year
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 7 Nov 2024.
- Results publication: PubMed 34329389Al-Zoubi EM, Al-Nimri KS. A comparative study between the effect of reverse curve of Spee archwires and anterior bite turbos in the treatment of deep overbite cases. Angle Orthod. 2022 Jan 1;92(1):36-44. doi: 10.2319/020921-117.1.
- the effect of reverse curve of Spee arch wires and anterior bite turbo in the treatment of deep biteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Samir A Ibrahem, proffesor principal investigator
Professor of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrusion by reverse curve wire in cervical position of twin slot bracket in people with Percentage of Deep Bite Correction, run by Faculty of Dental Medicine for Girls 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 8 inclusion and 5 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 7 Nov 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?
assessment of smile Line ,smile arch, upper lip line , buccal corridor and amount of intrusion of maxillary incisor (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06677619, which also lists 1 linked publication.
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 7 Nov 2024.