- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333836
Comparison of the Efficiency of Maxillary Canine Retraction Using Aligners Versus Conventional Brackets in Orthodontic Extraction Cases.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 11553
- Amr Mostafa Osman Ramadan
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Contact:
- Amr Ramadan, Master 's of orthodontics
- Phone Number: 0020106801410
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
1) Systematic disease.
2) Poor oral hygiene patients.
3 ) Periodontally affected teeth.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Aligners group
Receiving full set of aligners ( Clear Removable Orthodontic appliance) until complete canine retraction
|
|
ACTIVE_COMPARATOR: Conventional Brackets group
leveling and alignment of lower followed by complete canine retraction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canine Retraction (Space Closure )
Time Frame: 6 months
|
measured in millimeters
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canine Tipping
Time Frame: 6 months
|
it will be assessed by Angle degrees
|
6 months
|
Anchorage loss
Time Frame: 6 months
|
it will be assessed by Angle degrees
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Aligners in Canine Retraction
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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