Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws

NCT07661277 | Enrolling By Invitation DMC

• 1 other identifier: BMU/2026/1583
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic Anchorage Procedures

Keywords

Infra-zygomatic mini-screw; Orthodontic mini screw; temporary anchorage device; TAD; mini implant failure; mini screw stability; immediate loading; delayed loading; oral hygiene; CBCT; Orthodontic anchorage

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.

Other Outcomes (1)

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

  From October 25 to September 26

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-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.

Immediate loading mini-screw group

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

Delayed loading mini-screw group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanzila Rafique: lead

Study Sites (1)

Bangladesh Medical University (BMU), Dhaka,1000

Dhaka, 1000, Bangladesh

Location

Study Officials

• Mahmood Sajedeen, BDS,FCPS

  Bangladesh Medical University (BMU)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

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.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 8, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)