Orthodontic Anchorage ProceduresNCT07661277
Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
A study testing Immediate loading infra-zygomatic mini-screw and Delayed loading infra-zygomatic mini-screw in people with Orthodontic Anchorage Procedures, run by Tanzila Rafique at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Anchorage Procedures
- What is being tested?
- Immediate loading infra-zygomatic mini-screw and Delayed loading infra-zygomatic mini-screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Sep 2025to 8 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Bangladesh Medical University (BMU), Dhaka,1000
Dhaka, 1000
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Anchorage Procedures
- Being tested
- Immediate loading infra-zygomatic mini-screw, Delayed loading infra-zygomatic mini-screw
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate loading infra-zygomatic mini-screwProcedure or surgery
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-screwProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Delayed loading infra-zygomatic mini-screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- 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.
Measured: Over a three-month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion8 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Anchorage ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanzila Rafique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tanzila Rafique, Bangladesh Medical University
- Investigators
- Mahmood Sajedeen, BDS,FCPS, Study director, Bangladesh Medical University (BMU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661277
- Sponsor's protocol ID
- BMU/2026/1583
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With the Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
- ClinicalTrials.gov ID
- NCT07661277
- Acronym / sponsor ID
- BMU/2026/1583
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanzila RafiqueUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 8 Feb 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate loading mini-screw group | Active comparator | Procedure: Immediate loading infra-zygomatic mini-screwA 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 mini-screw group | Active comparator | Procedure: Delayed loading infra-zygomatic mini-screwA 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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate loading infra-zygomatic mini-screwA 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 or surgery | Immediate loading mini-screw group |
| Delayed loading infra-zygomatic mini-screwA 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 or surgery | Delayed loading mini-screw group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmood Sajedeen, BDS,FCPS study director
Bangladesh Medical University (BMU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate loading infra-zygomatic mini-screw and Delayed loading infra-zygomatic mini-screw in people with Orthodontic Anchorage Procedures, run by Tanzila Rafique at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.