- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07826182
Comparison Between Two Different Loops for Maxillary Canine Retraction
Comparison Between Two Different Loops for Maxillary Canine Retraction (Split Mouth Technique)(Randomized Clinical Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Orthodontic management of severe dental crowding and dentoalveolar protrusion frequently necessitates the extraction of maxillary first premolars. Following extraction, space closure is typically executed in a two-step procedure, initiated by isolated canine retraction to provide adequate space for subsequent incisor alignment and retraction.
Because canine retraction spans the longest duration of the space-closure phase, optimizing this stage is critical to achieving rapid, controlled tooth movement while minimizing adverse clinical effects like anchorage loss, root resorption, and unwanted tooth tipping or rotation.
In clinical orthodontics, canine retraction can be achieved through two primary biomechanical modalities: friction (sliding) mechanics and frictionless (loop/sectional) mechanics. While sliding mechanics are highly valued for their clinical simplicity, they generate significant frictional forces and binding at the bracket-arch wire interface. This friction can dissipate a substantial portion of the applied orthodontic force, cause unpredictable tooth movement and increase the risk of posterior anchorage strain. Conversely, frictionless mechanics eliminate these interface variables by utilizing specialized sectional wire loops to generate the required forces.
The success of frictionless canine retraction relies heavily on the structural design and configuration of the loop used.
Different loop designs such as the classic Burstone T-loop, the Opus loop, and the modified Marcotte spring exhibit distinct biomechanical properties:
- Load-Deflection Rate (LDR): Determines how rapidly the force decays as the tooth moves. A lower LDR provides a safer, more constant force over time.
- Moment-to-Force (M: F) Ratio: Governs the type of tooth movement achieved. Achieving a precise M:F ratio is mandatory to prevent uncontrolled distal tipping and promote controlled tipping or bodily movement (translation).
Despite extensive laboratory and limited element analyses detailing the theoretical behavior of various loop designs, translating these findings into real-world performance remains challenging. Individual biological variations such as; bone remodeling rates, alveolar bone density, and patient compliance introduce confounding variables that can twist clinical outcomes in traditional parallel-group clinical trials. To overcome these biological limitations, a split-mouth study design serves as an ideal methodology.
By randomly assigning different loop mechanics to opposing quadrants within the same maxillary arch of a single patient, each subject acts as their own perfectly matched control, effectively eliminating systemic biological bias. Recent clinical trials utilizing this design have started to clarify differences in loop efficiency.
For instance, comparisons between the Opus loop and the T-loop have demonstrated subtle variations in retraction rates, though both maintain comparable overall clinical performance.
Similarly, investigations contrasting the T-loop against alternative segmental systems, such as dual-force retractors or modified Marcotte springs, emphasize that loop configuration directly influences the duration of retraction, three-dimensional torque control, and the preservation of posterior anchorage.
While several clinical trials have compared sliding versus loop mechanics, head-to-head clinical comparisons evaluating efficiency, anchorage control, rotational tendencies, and patient comfort levels between different modern loop designs remain scarce. Consequently, there is an ongoing clinical debate regarding which loop configuration yields the most favorable balance between rapid canine retraction and optimal three-dimensional position control.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fayrouz Fayrouz Esam Ahmed Taher Mahmoud
- Phone Number: 0201016926903
- Email: fayrouzesam17@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 16-25 years.
- Class I or II div 1 malocclusion with moderate to severe crowding who are indicated for maxillary premolar extraction.
- Good oral hygiene and general health.
- Full eruption of maxillary permanent canines and second molars.
Exclusion Criteria:
- Systemic disease affecting bone remodeling eg.DM
- Previous extraction of permanent teeth.
- Periodontal disease or radiographic evidence of bone loss.
- Previous orthodontic treatment.
- Craniofacial anomalies or cleft lip and palate.
- Skeletal asymmetry.
- Orthodontic cases that could be treated with no indication for extraction
- Orthodontic cases that are indicated for extraction of any tooth other than maxillary first premolars.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Poul Gjessing (PG) Loop
orthodontic patient treated by Poul Gjessing (PG) spring for canine retraction.
|
orthodontic patient treated by Poul Gjessing (PG) spring for canine retraction.
|
|
Experimental: Modified Marcotte Loop
orthodontic patient treated by modified Marcotte spring for canine retraction.
|
orthodontic patient treated by Modified Marcotte spring for canine retraction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maxillary Canine Retraction
Time Frame: At the baseline visit (T-0), a dental impression and a CBCT scan will be obtained. For intermediate follow-up visits at months 1 through 5 (T-1 to T-5), dental impressions only will be recorded. At the final 6-month visit (T-6), both a dental impression
|
At the baseline visit (T-0), a dental impression and a CBCT scan will be obtained. For intermediate follow-up visits at months 1 through 5 (T-1 to T-5), dental impressions only will be recorded. At the final 6-month visit (T-6), both a dental impression
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Canine Retraction with Loops
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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