Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immediate loading infra-zygomatic mini-screw, Delayed loading infra-zygomatic mini-screw.
- Who it may be relevant to
- Registry conditions: Orthodontic Anchorage Procedures. Basic parameters: 19 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Factors Associated With the Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
Overview
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.
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.
Interventions
- 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. - 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
Primary outcome measures
- 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]
Secondary outcome measures (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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Bangladesh Medical University (BMU), Dhaka,1000 — Dhaka
Identifiers
NCT: NCT07661277 · BMU/2026/1583