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Outcome Measures

Primary Outcomes (1)

To assess the failure rate of infra-zygomatic orthodontic mini-screws over a three-month follow-up period. Failure will be defined as any degree of clinical mobility or loss of stability of the mini-screw.
This is a split-mouth randomized clinical study in which each participant will receive infra-zygomatic mini-screws bilaterally. One side will receive a 10 mm × 1.8 mm mini-screw with immediate loading, while the contralateral side will receive a 12 mm × 2.0 mm mini-screw with delayed loading. The failure rate will be assessed clinically over a three-month follow-up period.Mini-screw failure will be assessed clinically by the presence of mobility or loss of stability.
over a three-month follow-up period

Secondary Outcomes (1)

To assess the failure rate of infra-zygomatic orthodontic mini-screws over a three-month follow-up period. Failure will be defined as any degree of clinical mobility or loss of stability of the mini-screw
Over a three-month follow-up period.

Study Arms (2)

Immediate loading mini-screw group

ACTIVE COMPARATOR

A 10 mm length and 1.8 mm diameter infra-zygomatic mini-screw will be placed on one side of the maxillary arch and loaded immediately with orthodontic force.

Procedure: Immediate loading infra-zygomatic mini-screw

Delayed loading mini-screw group

ACTIVE COMPARATOR

A 12 mm length and 2.0 mm diameter infra-zygomatic mini-screw will be placed on the contralateral side of the maxillary arch and loaded after a delayed period.

Procedure: Delayed loading infra-zygomatic mini-screw

Interventions

Immediate loading infra-zygomatic mini-screwProcedure

A 10 mm length and 1.8 mm diameter infra-zygomatic mini-screw will be placed on one side of the maxillary arch and loaded immediately with orthodontic force.

Immediate loading mini-screw group

Delayed loading infra-zygomatic mini-screwProcedure

A 12 mm length and 2.0 mm diameter infra-zygomatic mini-screw will be placed on the contralateral side of the maxillary arch and loaded after a delayed period

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: This is a split-mouth randomized clinical study in which each participant will receive infra-zygomatic mini-screws bilaterally. One side will receive a 10 mm × 1.8 mm mini-screw with immediate loading, while the contralateral side will receive a 12 mm × 2.0 mm mini-screw with delayed loading. The failure rate will be assessed clinically over a three-month follow-up period.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Associate Professor

Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Immediate loading mini-screw group

Delayed loading mini-screw group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Immediate loading mini-screw group

Delayed loading mini-screw group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Locations