Implant StabilityTADsNCT07337538
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
A study testing insersion of two diameters of mini implant. in people with Implant Stability, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of this clinical trials is to compare two diameters, 1.6 and 2 mm, of mini implants both are 12 mm length placed in the infrazygomatic crest region. The main questions it aims to answer are: which diameter is more suitable for IZC region 1.6 or 2mm in terms of primary stability, secondary stability, pain… Read more about this study
- Who is it for?
- Ages 15 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Stability
- What is being tested?
- insersion of two diameters of mini implant.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 14 Jan 2026to 3 Nov 2026
- 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 15 to 38 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Individuals aged between 15 and 38 years.
- Patients currently undergoing orthodontic treatment with fixed appliances who require mini-implant placement in the upper buccal posterior region (IZC) for full-arch distalization or en-masse retraction.
- Patients willing and able to adhere to the study protocol.
- Recommended for the use of bilateral mini-implants.
Who cannot join
- Syndromic conditions, facial trauma, or previous bone-related surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)
The goal of this clinical trials is to compare two diameters, 1.6 and 2 mm, of mini implants both are 12 mm length placed in the infrazygomatic crest region. The main questions it aims to answer are:
which diameter is more suitable for IZC region 1.6 or 2mm in terms of primary stability, secondary stability, pain perception and failure rate.
20 participant will receive 40 mini implant bilaterally (20 in one side of 1.6mm, the other side 20 of 2mm).
participants will be asked to record visual analog scale (VAS) for 3 nights monitored monthly by the investigator.
Read the detailed description
Using 1.6x12mm and 2x12mm of mini implants in the IZC area and measuring primary stability, secondary stability, failure rate and pain perception.
The primary stability will be measured immediately after insertion using Easycheck device (Dentium, South Korea).
The secondary stability will be measured two months after insertion using the same device.
Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion, it will be checked monthly for six months.
pain perception will be recorded by patients using visual analog scale (VAS) score sheet 24 , 48, 72 hour after insertion.
Null hypothesis There is no significant difference between 1.6 and 2mm IZC mini implant diameters in terms of primary stability, secondary stability, failure rate and pain perception.
- Conditions
- Implant Stability
- Being tested
- insersion of two diameters of mini implant.
- Keywords
- temporary anchorage device stability, Tads, mini implant, miniscrew
- Medical subject headings
- Tietz syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insersion of two diameters of mini implant.Device
insertion of the two diameters in the infrazygomatic crest region (IZC) bilaterally (one for each side) then check difference in primary stability, secondary stability, pain perception and failure rate.
| Study group | Role | What they receive |
|---|---|---|
| 1.6 mm | Experimental | 1.6 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation. Receives: Device: insersion of two diameters of mini implant. |
| 2 mm | Experimental | 2 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation. Receives: Device: insersion of two diameters of mini implant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary stability
primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
Measured: immediately after insertion
secondary stability
secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
Measured: two month after insertion.
Secondary outcomes (2)
pain perception
using Visual Analogue Score (VAS) [1-10] higher score means higher pain.
Measured: after insertion 24 hour, 48 hour, 72 hour.
Failure rate
Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion.
Measured: monthly for six months after insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start14 Jan 2026
- Primary completion3 Jul 2026
- Study completion3 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant StabilityStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 20 participants will be enrolled. Each participant will receive two interventions concurrently, with a 1.6-mm diameter mini-implant placed on one infra-zygomatic crest and a 2.0-mm diameter mini-implant placed on the contralateral side. The side allocation of implant diameter will be randomized in an alternating manner (left-right).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Jabbar Al Ameri, University of Baghdad
- Investigators
- Ali J. Al Ameri, BDS., Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337538
- Sponsor's protocol ID
- 1152425
- Acronym
- TADs
- Status last verified
- Sep 2026
- First submitted
- 1 Jan 2026
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07337538
- Acronym / sponsor ID
- TADs / 1152425
- Conditions
- Implant Stability
- Keywords
- temporary anchorage device stability, Tads, mini implant, miniscrew
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 3 Nov 2026 (estimated)
- First posted
- 13 Jan 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 clinical trials is to compare two diameters, 1.6 and 2 mm, of mini implants both are 12 mm length placed in the infrazygomatic crest region. The main questions it aims to answer are:
which diameter is more suitable for IZC region 1.6 or 2mm in terms of primary stability, secondary stability, pain perception and failure rate.
20 participant will receive 40 mini implant bilaterally (20 in one side of 1.6mm, the other side 20 of 2mm).
participants will be asked to record visual analog scale (VAS) for 3 nights monitored monthly by the investigator.
Detailed description
Using 1.6x12mm and 2x12mm of mini implants in the IZC area and measuring primary stability, secondary stability, failure rate and pain perception.
The primary stability will be measured immediately after insertion using Easycheck device (Dentium, South Korea).
The secondary stability will be measured two months after insertion using the same device.
Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion, it will be checked monthly for six months.
pain perception will be recorded by patients using visual analog scale (VAS) score sheet 24 , 48, 72 hour after insertion.
Null hypothesis There is no significant difference between 1.6 and 2mm IZC mini implant diameters in terms of primary stability, secondary stability, failure rate and pain perception.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 20 participants will be enrolled. Each participant will receive two interventions concurrently, with a 1.6-mm diameter mini-implant placed on one infra-zygomatic crest and a 2.0-mm diameter mini-implant placed on the contralateral side. The side allocation of implant diameter will be randomized in an alternating manner (left-right).
| Arm | Type | Receives |
|---|---|---|
| 1.6 mm | Experimental | Device: insersion of two diameters of mini implant.1.6 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation. |
| 2 mm | Experimental | Device: insersion of two diameters of mini implant.2 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation. |
Who may qualify
- Ages
- 15 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Individuals aged between 15 and 38 years.
- Patients currently undergoing orthodontic treatment with fixed appliances who require mini-implant placement in the upper buccal posterior region (IZC) for full-arch distalization or en-masse retraction.
- Patients willing and able to adhere to the study protocol.
- Recommended for the use of bilateral mini-implants.
Key exclusion criteria (1 listed)
- Syndromic conditions, facial trauma, or previous bone-related surgery.
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 |
|---|---|---|
| insersion of two diameters of mini implant.insertion of the two diameters in the infrazygomatic crest region (IZC) bilaterally (one for each side) then check difference in primary stability, secondary stability, pain perception and failure rate. | Device | 1.6 mm, 2 mm |
Primary outcome
primary stability
Time frame: immediately after insertion
primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
secondary stability
Time frame: two month after insertion.
secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
2 secondary outcomes
pain perception
Time frame: after insertion 24 hour, 48 hour, 72 hour.
Failure rate
Time frame: monthly for six months after insertion.
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 16 Sep 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. This study is not recruiting at the moment.
Ali J. Al Ameri, BDS. principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insersion of two diameters of mini implant. in people with Implant Stability, run by University of Baghdad at 1 site in Iraq.
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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 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 Iraq. 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?
primary stability (time frame: immediately after insertion). The study lists 2 primary outcomes in all. 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 16 Sep 2026.