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Measuring Rate of Anteriors Retraction With Two Different Techniques

Primary Purpose

Class II Division 1 Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
palatal and buccal retraction
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Orthodontics, incisors retraction, mini-implants, direct- anchorage.

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. Class II division 1 malocclusion with no or mild crowding 2. Age ranging from 14 to 18 years.

Exclusion Criteria:

  • No previous orthodontic therapy of any type prior to this treatment No systematic disease Good oral hygiene and no periodontal problems No abnormal oral habits

Sites / Locations

  • Egypt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

palatal retractor

buccal retractor

Arm Description

palatal retraction

buccal retraction

Outcomes

Primary Outcome Measures

rate of retraction
distance travelled at specific time interval

Secondary Outcome Measures

Full Information

First Posted
September 11, 2022
Last Updated
September 13, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05542745
Brief Title
Measuring Rate of Anteriors Retraction With Two Different Techniques
Official Title
Rate of Upper Incisors Retraction in Class II Division 1 Patients Managed With Palatal Versus Buccal Miniscrew Supported Segmental Orthodontics: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
July 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Few studies had investigated the effectiveness of segmental retraction. As a result of that, this study was concerned about comparing retraction rate of maxillary incisors between buccal and palatal mini-implant supported retraction groups in Class II division 1 non growing patients for 3 months interval.
Detailed Description
Almost all patients their primary concern is the total duration of orthodontic treatment. So, the need to choose the best mean to fasten the tooth movement rate with least drawbacks increased . Many new bracket techniques and prescriptions have been evolved since straight wire technique of Andrew's was advanced. All of these progressions are to make a system of force which can decrease the overall management time. Commonly, extractions and maximum anchorage are planned to manage different malocclusions in orthodontic treatment especially in protrusion cases. Space closure is an important step following extraction. So, space closure strategy must be individually adjusted depending on diagnosis and plan of treatment. Nowadays several options are used to fasten movement of tooth. New techniques like implants assisted retraction, lessen the time of retraction and accordingly the total time of treatment. Control of anchorage is an important factor in orthodontic therapy success. Mini-implants are method of absolute anchorage control .These systems improves the anchorage, but still have some drawbacks like surgical intervention and patient compliance. However, their usage becomes a necessity and unavoidable in many cases. Buccal TADs could provide superior results when retracting anterior teeth in patients with moderate to severe protrusion. Lingual orthodontics introduction created novel horizons in orthodontic therapy. Labial orthodontics varied differentially in biomechanics from the lingual one. Because of its positional biomechanical advantage, lingual orthodontics offers higher anchorage and higher rate of retraction; as the lingual appliance force applied near to the tooth center of resistance than in the labial ones. Control of torque is not simple in traditional lingual orthodontics. The C-lingual retractor is great for lip protrusion cases that need maximum anchorage.Bonding the C-retractor to the palatal aspect of the upper anteriors, adding maximum esthetics. Mini-implants are inserted palataly and decrease the need of posterior anchorage for retraction of upper anterior teeth. This is named lingual biocreative therapy. Palatal TSADs can provide wide range of force application level, due to the depth of palatal vault. By the adjustment of the lever arm length and position of miniscrews, the desired line of action of the retraction force with respect to the center of resistance of the anterior segment can be achieved.Segmental retraction is an approach using palatal TSADs as direct anchorage. The anterior teeth were splinted on the lingual side, and they are retracted to the palatal TSADs using elastomers or NiTi coil springs through a lever connected to the anterior segment. It is critical to locate and manage the center of resistance relative to the force vector of retraction. By using this, the orthodontist can estimate the power arm length which would provide controlled tipping, or bodily movement of the anterior area. There is a lack of studies evaluating the rate of movement of incisors in cases treated with palatal retraction so new investigations are needed in this area. Because of the biomechanical differences between buccal and palatal retraction, this study targeted the comparison of the rate of retraction in upper anteriors following leveling and alignment in class II division 1 patients managed by either method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
Keywords
Orthodontics, incisors retraction, mini-implants, direct- anchorage.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
palatal retractor
Arm Type
Active Comparator
Arm Description
palatal retraction
Arm Title
buccal retractor
Arm Type
Active Comparator
Arm Description
buccal retraction
Intervention Type
Device
Intervention Name(s)
palatal and buccal retraction
Intervention Description
comparison
Primary Outcome Measure Information:
Title
rate of retraction
Description
distance travelled at specific time interval
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Class II division 1 malocclusion with no or mild crowding 2. Age ranging from 14 to 18 years. Exclusion Criteria: No previous orthodontic therapy of any type prior to this treatment No systematic disease Good oral hygiene and no periodontal problems No abnormal oral habits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ElBialy
Organizational Affiliation
Faculty of Dentistry Mansoura Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Egypt
City
Mansoura
ZIP/Postal Code
+20
Country
Egypt

12. IPD Sharing Statement

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Measuring Rate of Anteriors Retraction With Two Different Techniques

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