Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws

June 18, 2026 updated by: Tanzila Rafique

Factors Associated With the Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws

The goal of this randomized clinical study is to assess the factors associated with the failure rate of infra-zygomatic crest orthodontic mini-screws used for anchorage reinforcement during orthodontic treatment.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Researchers will evaluate the influence of mini-screw length, diameter, oral hygiene status, age, sex, and loading time on the failure rate of infra-zygomatic mini-screws. Mini-screw failure will be assessed clinically by the presence of mobility or loss of stability.

Participants will:

  • Receive fixed orthodontic treatment with a pre-adjusted edgewise appliance system.
  • Receive infra-zygomatic mini-screws bilaterally for maxillary anchorage reinforcement.
  • Receive a 10 mm × 1.8 mm mini-screw on one side with immediate loading.
  • Receive a 12 mm × 2.0 mm mini-screw on the contralateral side with delayed loading.
  • Receive standardized orthodontic force using elastic power chain.
  • Undergo CBCT assessment to evaluate the position of the inserted mini-screws.
  • Be evaluated at baseline and at one-month intervals for three consecutive months to assess mini-screw mobility or failure.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Bangladesh Medical University (BMU), Dhaka,1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants aged 19 to 35 years.
  • Both male and female participants.
  • Patients requiring absolute anchorage for maxillary arch and orthodontic tooth movement.
  • Patients undergoing fixed orthodontic treatment.
  • Patients in whom infra-zygomatic mini-screws are indicated for anchorage reinforcement.
  • Participants whose oral hygiene status can be clinically assessed.
  • Participants willing to provide written informed consent.

Exclusion Criteria:

  • Patients with incomplete history or records
  • Patients with a history of previous orthodontic treatment.
  • Patients with a history of maxillofacial surgery.
  • Patients with a history of head or facial trauma.
  • Patients with temporomandibular joint disorder.
  • Medically compromised patients.
  • Patients with diagnosed syndromes, congenital defects, or facial deformities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Immediate loading mini-screw group
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
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.
Active Comparator: Delayed loading mini-screw group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: over a three-month follow-up period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Over a three-month follow-up period.
  • To compare the failure rate of infra-zygomatic mini-screws according to age and sex of the participants.
  • To evaluate the influence of mini-screw length on failure rate.
  • To evaluate the influence of mini-screw diameter on failure rate.
  • To assess the relationship between oral hygiene status and mini-screw failure.
  • To compare the effect of immediate and delayed loading on mini-screw failure.
  • To assess the position of inserted mini-screws using CBCT.
  • To evaluate the clinical usefulness of infra-zygomatic mini-screws as temporary anchorage devices in orthodontic treatment.
Over a three-month follow-up period.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors Associated with the Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
Time Frame: From October 25 to September 26

This randomized clinical study will assess the factors associated with the failure rate of infra-zygomatic crest orthodontic mini-screws used for anchorage reinforcement during orthodontic treatment. Researchers will evaluate the influence of mini-screw length, diameter, oral hygiene status, age, sex, and loading time on the failure rate of infra-zygomatic mini-screws. Mini-screw failure will be assessed clinically by the presence of mobility or loss of stability.

Participants will receive:

  • fixed orthodontic treatment with a pre-adjusted edgewise appliance system
  • infra-zygomatic mini-screws bilaterally for maxillary anchorage reinforcement
  • 10 mm × 1.8 mm mini-screw on one side with immediate loading
  • a 12 mm × 2.0 mm mini-screw on the contralateral side with delayed loading
  • standardized orthodontic force using elastic power chain CBCT will be carried out at baseline and at one-month intervals for three consecutive months to assess mini-screw mobility or failure.
From October 25 to September 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanzila Rafique

Investigators

  • Study Director: Mahmood Sajedeen, BDS,FCPS, Bangladesh Medical University (BMU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

February 8, 2027

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BMU/2026/1583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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