Bimaxillary ProclinationNCT03579745
Evaluation of Profile Changes and Torque Control in Dental Bimaxillary Proclination Cases Using Lingual Lever Arm Mechanics vs Conventional Lingual Orthodontic Mechanics A Randomized Controlled Trial
A study testing Lingual orthodontics in people with Bimaxillary Proclination, run by Cairo University.
Trial summary
This study evaluates the profile changes and torque control using lingual lever arm vs conventional lingual mechanics. Half of the patients will receive lever arms and the other half will receive conventional lingual orthodontics. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Bimaxillary Proclination
- What is being tested?
- Lingual orthodontics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jun 2020
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adult patients with age range 18-30 yrs old.
- Class I bimaxillary dentoalveolar proclination.
- Full permanent dentition.
- Good oral hygiene.
- Maximum anchorage is required.
- Healthy bone around the first molars is needed.
Who cannot join
- .Systemic disease.
- Severe crowding.
- Extracted or missing upper permanent tooth/teeth (except for third molars).
- Signs, symptoms or previous history of temporomandibular disorders (TMD).
- Previous orthodontic treatment.
Trial locations and contacts
No sites are listed yet.
About this study
This study evaluates the profile changes and torque control using lingual lever arm vs conventional lingual mechanics. Half of the patients will receive lever arms and the other half will receive conventional lingual orthodontics.
Read the detailed description
Conventional lingual orthodontic biomechanics leads to torque loss during en masse retraction of the anterior segment in the bimaxillary proclination cases treated by first premolar extraction. Torque loss affects the final outcome of the treatment negatively.
Adding a lever arm to the lingual wire will transmit the point of force application at or apical to the center of rotation which will reduce or eliminate toqrue loss during anterior segment retraction.
- Conditions
- Bimaxillary Proclination
- Being tested
- Lingual orthodontics
- Keywords
- lingual orthodontics, Lever arm, En masse retraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual orthodonticsProcedure or surgery
Also called Conventional lingual mechanics
A coil spring will be attached from the lever arm to the first molar tube
| Study group | Role | What they receive |
|---|---|---|
| Conventional lingual mechanics | Active comparator | Not described Receives: Procedure: Lingual orthodontics |
| Lever arm lingual mechanics | Experimental | Not described Receives: Procedure: Lingual orthodontics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasolabial angle
Soft tissue lateral cephalometric radiograph measurement
Measured: 12 months
Profile convexity reduction
N'-sn -Pog' soft tissue angle
Measured: 12 months
Secondary outcomes (1)
Torque control
U1 - Palatal plane angle
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study startOct 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bimaxillary ProclinationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kandil, Cairo University
- Investigators
- Amr Abuelezz, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579745
- Sponsor's protocol ID
- AKandil
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Profile Changes and Torque Control in Dental Bimaxillary Proclination Cases Using Lingual Lever Arm Mechanics vs Conventional Lingual Orthodontic Mechanics A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03579745
- Acronym / sponsor ID
- AKandil
- Conditions
- Bimaxillary Proclination
- Keywords
- lingual orthodontics, Lever arm, En masse retraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 9 Jul 2018 (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 evaluates the profile changes and torque control using lingual lever arm vs conventional lingual mechanics. Half of the patients will receive lever arms and the other half will receive conventional lingual orthodontics.
Detailed description
Conventional lingual orthodontic biomechanics leads to torque loss during en masse retraction of the anterior segment in the bimaxillary proclination cases treated by first premolar extraction. Torque loss affects the final outcome of the treatment negatively.
Adding a lever arm to the lingual wire will transmit the point of force application at or apical to the center of rotation which will reduce or eliminate toqrue loss during anterior segment retraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional lingual mechanics | Active comparator | Procedure: Lingual orthodontics |
| Lever arm lingual mechanics | Experimental | Procedure: Lingual orthodontics |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female adult patients with age range 18-30 yrs old.
- Class I bimaxillary dentoalveolar proclination.
- Full permanent dentition.
- Good oral hygiene.
- Maximum anchorage is required.
Key exclusion criteria (5 listed)
- .Systemic disease.
- Severe crowding.
- Extracted or missing upper permanent tooth/teeth (except for third molars).
- Signs, symptoms or previous history of temporomandibular disorders (TMD).
- Previous orthodontic treatment.
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 |
|---|---|---|
| Lingual orthodonticsAlso: Conventional lingual mechanicsA coil spring will be attached from the lever arm to the first molar tube | Procedure or surgery | Conventional lingual mechanics, Lever arm lingual mechanics |
Primary outcome
Nasolabial angle
Time frame: 12 months
Soft tissue lateral cephalometric radiograph measurement
Profile convexity reduction
Time frame: 12 months
N'-sn -Pog' soft tissue angle
1 secondary outcome
Torque control
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: No
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Bimaxillary Proclination, Bimaxillary Protrusion
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.
Amr Abuelezz, Professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Lingual orthodontics in people with Bimaxillary Proclination, run by Cairo University.
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 6 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: status not confirmed, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Kandil Al Asfar, Masters (01008087762 ext. 20, Kandilahmed04@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasolabial angle (time frame: 12 months). The study lists 2 primary outcomes in all. 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 9 Jul 2018.