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Enrolling by Invitation

NCT Number: NCT07661277

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.

Enrolling by Invitation

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Key information

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bangladesh Medical University (BMU), Dhaka,1000

Dhaka, 1000, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate loading infra-zygomatic mini-screw

Procedure

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.

Delayed loading infra-zygomatic mini-screw

Procedure

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

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.

    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.

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

    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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tanzila Rafique

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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