Orthodontic Anchorage Procedures
Conditions
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
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.
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
PROCEDUREImmediate 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.
PROCEDUREDelayed 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
Sponsors
Tanzila Rafique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | * 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. |
Countries
Bangladesh
Contacts
STUDY_DIRECTORMahmood Sajedeen, BDS,FCPS
Bangladesh Medical University (BMU)
Outcome results
None listed