Orthodontic Appliance ComplicationNCT06293872
Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region
A study testing 12*2 mm length miniscrew in people with Orthodontic Appliance Complication, run by University of Baghdad at 1 site in Iraq.
Trial summary
Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- 12*2 mm length miniscrew
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIraq
- Study dates
- 25 Feb 2023to 28 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a. Patients (age of patients is 15-50 y.) need metal fixed orthodontic treatment including placement of miniscrews.
- The position of mini-implant in upper buccal posterior area (infrazygomatic area).
Who cannot join
- • If c.b.c.t show that the screw placed intraradicular will be excluded.
- Patient choose to discontinue the treatment was regarded as dropout, since this study pre protocol analysis. exclusion criteria, such as images suggesting
- Images suggesting sinus inflammation or pathology before mini-implant insertin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region (A Randomized Clinical Trial, Split-mouth Study)
Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate.
Read the detailed description
orthodontic mini-implants, also known as miniscrew, implants or temporary anchorage devices, offer an effective panacea for Anchorage loss problem during fixed appliance treatments.
Indeed, Mini-implant implantation has become an essential method of controlling anchorage in the clinic and plays an important role in solving some difficult cases, where the integration of orthodontic mini-implants within fixed appliance treatments offers other advantages over conventional anchorage.
Intra-radicular micro-implants are placed in between the roots of teeth (mostly) while extra-radicular bone screws are placed away from the roots in the infra-zygomatic areas (IZC) of the maxilla and the buccal shelf areas (BS) of the mandible. Both extra-radicular bone screws and intra-radicular are classified under temporary anchorage devices used for the purpose of skeletal anchorage.
Due to the limited space, there is a risk of injury to the roots while using Intra-radicular micro-implants. Therefore, the infrazygomatic crest zone is selected as an alternative implantation site in the clinic. The infrazygomatic crest has a double-layered cortex and is close to the maxillary center of the resistance, which is suitable for implantation and provides strong anchorage.
Orthodontic bone screws can be used in almost every clinical situation that a micro-implant is used for, except that they cannot be placed inter-dental purely because of their larger dimension. They can be used for molar uprighting, segmental, and full arch distalization, intrusion of single tooth to full arch, protraction and retraction of dentition and for any other anchorage needs.
the two most specific indications would be - full arch distalization of maxillary and mandibular dentition to camouflage a Class II and a Class III malocclusion and for distalization of arches in re-treatment cases of anchorage loss, which are otherwise difficult to be done with a regular micro-implant or time-consuming.
However, it is adjacent to the maxillary sinus and tooth roots; therefore, we have to consider many factors, such as bone mass, the thickness of the buccal cortex and the relationship with the maxillary sinus and roots, before implantation in the infrazygomatic crest. Furthermore, previous research by our research group found that it is safe to penetrate the maxillary sinus within 1 mm.
This study will be conducted to test the feasibility, reliability of using two different sizes of infrazygomatic mini-implant regarding primary stability, pain perception, sinus penetration, secondary stability, and failure rate.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- 12*2 mm length miniscrew
- Keywords
- mini-screws, infrazygomatic crest zone, IZC, orthodontics implant.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12*2 mm length miniscrewDevice
Also called 14*2 mm length miniscrew
Prior to mini-inplant insertion the patient will instructed to rinse mouth with chlorhexidine mouthwash, then local anesthesia will be applied.
The clinical implication for miniscrew insertion in the IZ crest of adults is 14 to 16 mm above the maxillary occlusal plane and the maxillary first molar.
The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa.
Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots
| Study group | Role | What they receive |
|---|---|---|
| 12*2 mm length miniscrew | Experimental | The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa.
Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots. Receives: Device: 12*2 mm length miniscrew |
| 14*2 mm length miniscrew | Active comparator | The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa.
Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots. Receives: Device: 12*2 mm length miniscrew |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate
the miniscrew regarded as failed if it is mobile and can not fulfill it is anchorage function, covered by soft tissue.
Measured: 6 months
Secondary outcomes (3)
primary stability
primary stability measured for each patient immediately after placemat with use of Dentium stability measuring system (EasyCheck).
Measured: immediately after placement
secondary stability
secondary stability measured for each patient immediately after placemat with use of Dentium stability measuring system (EasyCheck).
Measured: after 6months
pain perception
Patients asked to record any pain experienced on the visual analog scale (VAS) score.
Measured: after 1st day and after 1st week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start25 Feb 2023
- Primary completion10 Jul 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbas Fadhil Alsaeedi, University of Baghdad
- Investigators
- Mehdi abd Alrubayee, B.D.S; M.Sc; PhD, Study director, Assistant Professor, Department of Orthodontics, College of Dentistry, University of Baghdad, Iraq.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293872
- Sponsor's protocol ID
- IZC miniscrew
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Alsaeedi AF, Alrubayee MA, Sivamurthy G. Evaluation of Two Mini-implant Lengths in the Infrazygomatic Crest Region: A Randomized Clinical Trial. Eur J Dent. 2025 May;19(2):399-408. doi: 10.1055/s-0044-1789015. Epub 2024 Nov 7.
PubMed 39510519
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region (A Randomized Clinical Trial, Split-mouth Study)
- ClinicalTrials.gov ID
- NCT06293872
- Acronym / sponsor ID
- IZC miniscrew
- Conditions
- Orthodontic Appliance Complication
- Keywords
- mini-screws, infrazygomatic crest zone, IZC, orthodontics implant.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 5 Mar 2024 (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.
Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate.
Detailed description
orthodontic mini-implants, also known as miniscrew, implants or temporary anchorage devices, offer an effective panacea for Anchorage loss problem during fixed appliance treatments.
Indeed, Mini-implant implantation has become an essential method of controlling anchorage in the clinic and plays an important role in solving some difficult cases, where the integration of orthodontic mini-implants within fixed appliance treatments offers other advantages over conventional anchorage.
Intra-radicular micro-implants are placed in between the roots of teeth (mostly) while extra-radicular bone screws are placed away from the roots in the infra-zygomatic areas (IZC) of the maxilla and the buccal shelf areas (BS) of the mandible. Both extra-radicular bone screws and intra-radicular are classified under temporary anchorage devices used for the purpose of skeletal anchorage.
Due to the limited space, there is a risk of injury to the roots while using Intra-radicular micro-implants. Therefore, the infrazygomatic crest zone is selected as an alternative implantation site in the clinic. The infrazygomatic crest has a double-layered cortex and is close to the maxillary center of the resistance, which is suitable for implantation and provides strong anchorage.
Orthodontic bone screws can be used in almost every clinical situation that a micro-implant is used for, except that they cannot be placed inter-dental purely because of their larger dimension. They can be used for molar uprighting, segmental, and full arch distalization, intrusion of single tooth to full arch, protraction and retraction of dentition and for any other anchorage needs.
the two most specific indications would be - full arch distalization of maxillary and mandibular dentition to camouflage a Class II and a Class III malocclusion and for distalization of arches in re-treatment cases of anchorage loss, which are otherwise difficult to be done with a regular micro-implant or time-consuming.
However, it is adjacent to the maxillary sinus and tooth roots; therefore, we have to consider many factors, such as bone mass, the thickness of the buccal cortex and the relationship with the maxillary sinus and roots, before implantation in the infrazygomatic crest. Furthermore, previous research by our research group found that it is safe to penetrate the maxillary sinus within 1 mm.
This study will be conducted to test the feasibility, reliability of using two different sizes of infrazygomatic mini-implant regarding primary stability, pain perception, sinus penetration, secondary stability, and failure rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12*2 mm length miniscrew | Experimental | Device: 12*2 mm length miniscrewThe self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa. Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots. |
| 14*2 mm length miniscrew | Active comparator | Device: 12*2 mm length miniscrewThe self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa. Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- a. Patients (age of patients is 15-50 y.) need metal fixed orthodontic treatment including placement of miniscrews.
- The position of mini-implant in upper buccal posterior area (infrazygomatic area).
Key exclusion criteria (3 listed)
- • If c.b.c.t show that the screw placed intraradicular will be excluded.
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 |
|---|---|---|
| 12*2 mm length miniscrewAlso: 14*2 mm length miniscrewPrior to mini-inplant insertion the patient will instructed to rinse mouth with chlorhexidine mouthwash, then local anesthesia will be applied. The clinical implication for miniscrew insertion in the IZ crest of adults is 14 to 16 mm above the maxillary occlusal plane and the maxillary first molar. The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa. Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots | Device | 12*2 mm length miniscrew, 14*2 mm length miniscrew |
Primary outcome
failure rate
Time frame: 6 months
the miniscrew regarded as failed if it is mobile and can not fulfill it is anchorage function, covered by soft tissue.
3 secondary outcomes
primary stability
Time frame: immediately after placement
secondary stability
Time frame: after 6months
pain perception
Time frame: after 1st day and after 1st week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 39510519Alsaeedi AF, Alrubayee MA, Sivamurthy G. Evaluation of Two Mini-implant Lengths in the Infrazygomatic Crest Region: A Randomized Clinical Trial. Eur J Dent. 2025 May;19(2):399-408. doi: 10.1055/s-0044-1789015. Epub 2024 Nov 7.
- Individual participant dataSharing planned: Yes
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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.
Mehdi abd Alrubayee, B.D.S; M.Sc; PhD study director
Assistant Professor, Department of Orthodontics, College of Dentistry, University of Baghdad, Iraq.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12*2 mm length miniscrew in people with Orthodontic Appliance Complication, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 5 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
failure rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06293872, which also lists 1 linked publication.
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 5 Mar 2024.