Removable Aligners, Conventional BracketsNCT04333836
Comparison of the Efficiency of Maxillary Canine Retraction Using Aligners Versus Conventional Brackets in Orthodontic Extraction Cases.
A study testing Removable Clear Aligners in people with Removable Aligners, Conventional Brackets, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effectiveness of Clear aligners and Conventional braces for upper canine retraction (space closure) regarding canine tipping , anchorage loss and treatment time. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Removable Aligners, Conventional Brackets
- What is being tested?
- Removable Clear Aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2020to Jan 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1) Moderate to severe crowding orthodontic patients.( Irregularity index of <5 mm)
- 2) Good oral hygiene. (Patient with periodontally sound dentition).
- 3) Patient in permanent dentition between the age range 16 - 40 years.
- 4) .Patients requiring extraction of mandibular and maxillary first premolars;
- 5) Patients having sound general health
Who cannot join
- 1) Systematic disease.
- 2) Poor oral hygiene patients.
- 3 ) Periodontally affected teeth.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Amr Mostafa Osman Ramadan
Cairo, 11553
Amr Ramadan, Master 's of orthodontics, 0020106801410
About this study
The aim of this study is to compare the effectiveness of Clear aligners and Conventional braces for upper canine retraction (space closure) regarding canine tipping , anchorage loss and treatment time.
Read the detailed description
Conventional fixed orthodontic treatment with metal brackets has been rejected by some adult patients because of esthetic and social concerns, but the demand for orthodontic treatment is currently increasing. To satisfy the demands and needs of these patients, the emphasis has shifted toward esthetic orthodontic appliance system. Less noticeable appliances such as ceramic, resin, and lingual brackets, or removable clear appliances such as the Essix and Invisalign (Align Technology, Santa Clara, Calif) provide esthetic orthodontic appliance alternatives.
Since the introduction of clear aligners to the public in 1999, it has become a popular treatment choice for clinicians because of the aesthetics and comfort of the removable clear aligners compared with traditional appliances. Several studies have shown significant limitations of this technique, especially in treating complex malocclusions, whereas other studies have reported successfully treated cases with this removable appliance. A systematic review conducted to determine the treatment effects of clear aligners showed that no strong conclusions could be made regarding the treatment effects of aligners . Therefore, clinical trials were still required to investigate the effectiveness of the Invisalign system.
When using the aligners to correct severe crowding, root positions must be carefully controlled during extraction space closure, and clear aligners must be properly grip all teeth to be moved, Tipping was a common problem in premolar extraction cases during the early years of aligners use. Several previous reports have also discussed the limited ability of thermoplastic appliances to control root-tipping movements and to establish root control comparable to that provided by fixed appliances. The investigators describe the extraction treatment of a patient with moderate to severe tooth crowding using mini screws and clear appliances, thus eliminating the need for conventional brackets.
- Being tested
- Removable Clear Aligners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable Clear AlignersDevice
- Plaster dental models will be poured from the rubber base impression.
- Digital dental models will be created through scanning of plaster dental models.
- Planning of the aligners will be done on 3 shape clear aligner studio®.
- Aligners will be fabricated on 3d printed models using vacuum formers.
- Anchorage reinforcement for posterior segments by using buccal miniscrews.
- Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.
- Patient will receive the following aligner after 2 weeks.
- Follow up visits every 2 weeks until complete canine retraction.
| Study group | Role | What they receive |
|---|---|---|
| Aligners group | Experimental | Receiving full set of aligners ( Clear Removable Orthodontic appliance) until complete canine retraction Receives: Device: Removable Clear Aligners |
| Conventional Brackets group | Active comparator | leveling and alignment of lower followed by complete canine retraction Receives: Device: Removable Clear Aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canine Retraction (Space Closure )
measured in millimeters
Measured: 6 months
Secondary outcomes (2)
Canine Tipping
it will be assessed by Angle degrees
Measured: 6 months
Anchorage loss
it will be assessed by Angle degrees
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study startJul 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Removable Aligners, Conventional BracketsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mostafa Osman Ramadan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333836
- Sponsor's protocol ID
- Aligners in Canine Retraction
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Maxillary Canine Retraction Using Aligners Versus Conventional Brackets in Orthodontic Extraction Cases.
- ClinicalTrials.gov ID
- NCT04333836
- Acronym / sponsor ID
- Aligners in Canine Retraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 3 Apr 2020 (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.
The aim of this study is to compare the effectiveness of Clear aligners and Conventional braces for upper canine retraction (space closure) regarding canine tipping , anchorage loss and treatment time.
Detailed description
Conventional fixed orthodontic treatment with metal brackets has been rejected by some adult patients because of esthetic and social concerns, but the demand for orthodontic treatment is currently increasing. To satisfy the demands and needs of these patients, the emphasis has shifted toward esthetic orthodontic appliance system. Less noticeable appliances such as ceramic, resin, and lingual brackets, or removable clear appliances such as the Essix and Invisalign (Align Technology, Santa Clara, Calif) provide esthetic orthodontic appliance alternatives.
Since the introduction of clear aligners to the public in 1999, it has become a popular treatment choice for clinicians because of the aesthetics and comfort of the removable clear aligners compared with traditional appliances. Several studies have shown significant limitations of this technique, especially in treating complex malocclusions, whereas other studies have reported successfully treated cases with this removable appliance. A systematic review conducted to determine the treatment effects of clear aligners showed that no strong conclusions could be made regarding the treatment effects of aligners . Therefore, clinical trials were still required to investigate the effectiveness of the Invisalign system.
When using the aligners to correct severe crowding, root positions must be carefully controlled during extraction space closure, and clear aligners must be properly grip all teeth to be moved, Tipping was a common problem in premolar extraction cases during the early years of aligners use. Several previous reports have also discussed the limited ability of thermoplastic appliances to control root-tipping movements and to establish root control comparable to that provided by fixed appliances. The investigators describe the extraction treatment of a patient with moderate to severe tooth crowding using mini screws and clear appliances, thus eliminating the need for conventional brackets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aligners group | Experimental | Device: Removable Clear AlignersReceiving full set of aligners ( Clear Removable Orthodontic appliance) until complete canine retraction |
| Conventional Brackets group | Active comparator | Device: Removable Clear Alignersleveling and alignment of lower followed by complete canine retraction |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 1) Moderate to severe crowding orthodontic patients.( Irregularity index of <5 mm)
- 2) Good oral hygiene. (Patient with periodontally sound dentition).
- 3) Patient in permanent dentition between the age range 16 - 40 years.
- 4) .Patients requiring extraction of mandibular and maxillary first premolars;
- 5) Patients having sound general health
Key exclusion criteria (3 listed)
- 1) Systematic disease.
- 2) Poor oral hygiene patients.
- 3 ) Periodontally affected teeth.
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 |
|---|---|---|
| Removable Clear Aligners1. Plaster dental models will be poured from the rubber base impression. 2. Digital dental models will be created through scanning of plaster dental models. 3. Planning of the aligners will be done on 3 shape clear aligner studio®. 4. Aligners will be fabricated on 3d printed models using vacuum formers. 5. Anchorage reinforcement for posterior segments by using buccal miniscrews. 6. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks. 7. Patient will receive the following aligner after 2 weeks. 8. Follow up visits every 2 weeks until complete canine retraction. | Device | Aligners group, Conventional Brackets group |
Primary outcome
Canine Retraction (Space Closure )
Time frame: 6 months
measured in millimeters
2 secondary outcomes
Canine Tipping
Time frame: 6 months
Anchorage loss
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removable Clear Aligners in people with Removable Aligners, Conventional Brackets, 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 5 inclusion and 3 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 3 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canine Retraction (Space Closure ) (time frame: 6 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 3 Apr 2020.