Malaligned TeethNCT07662434
A Prospective , Split-mouth, Clinical Study of Orthodontic Titanium Miniscrews With Machined and Acid-etched Surfaces.
A study testing miniscrews placement in people with Malaligned Teeth and Crowding, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Primary goal of this study to check the stability of miniscrews used in orthodontic treatment in order to evaluate the success of the treatment. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaligned Teeth, Crowding
- What is being tested?
- miniscrews placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 2 Dec 2025
- 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 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Fixed appliance treatment with or without premolar extraction One or more miniscrews for same reason in each quadrant of maxilla or mandible Patient over 13 years Patient with permanent dentition\ Treatment plan should include miniscrews
Who cannot join
- Severe craniofacial deformities such as cleft lip and palate History of bone disease Cases with high expectation of failure due to anatomical limitation such as sinus pneumatization Narrow interproximal alveolar bone Attached gingiva deficiency Mixed Dentition
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Dentistry and Hospital
Islamabad, Federal, 44000
About this study
Primary goal of this study to check the stability of miniscrews used in orthodontic treatment in order to evaluate the success of the treatment.
Read the detailed description
Aim of the study is to compare the success rate and primary stability of surface treated versus non-treated miniscrews. Stability of screws is the major concern for an orthodontist during treatment. Surface treatment actually modify the surface by making it rough resulting in increase in surface area which provide better stability.
- Conditions
- Malaligned Teeth, Crowding
- Being tested
- miniscrews placement
- Keywords
- Miniscrews, Acid-etched Miniscrews
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miniscrews placementDevice
Placement of miniscrews under local anesthesia in both groups
| Study group | Role | What they receive |
|---|---|---|
| experimental group: Acid etcehd miniscrews | Experimental | Placement of surface treated screws Receives: Device: miniscrews placement |
| Control Group with conventional miniscrews | Placebo comparator | Non-surface treated miniscrews Receives: Device: miniscrews placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Stability of of machined and acid-etched miniscrews
Absence of clinical stability of miniscrews (>1mm)
Measured: After one month of insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start20 Jun 2024
- Primary completion2 Oct 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malaligned TeethStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662434
- Sponsor's protocol ID
- FUCDCLINIC-2406
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy
Publications
Yoo SH, Park YC, Hwang CJ, Kim JY, Choi EH, Cha JY. A comparison of tapered and cylindrical miniscrew stability. Eur J Orthod. 2014 Oct;36(5):557-62. doi: 10.1093/ejo/cjt092. Epub 2013 Dec 19.
PubMed 24355870Chen YJ, Chang HH, Huang CY, Hung HC, Lai EH, Yao CC. A retrospective analysis of the failure rate of three different orthodontic skeletal anchorage systems. Clin Oral Implants Res. 2007 Dec;18(6):768-75. doi: 10.1111/j.1600-0501.2007.01405.x. Epub 2007 Sep 14.
PubMed 17868386Chang C, Liu SS, Roberts WE. Primary failure rate for 1680 extra-alveolar mandibular buccal shelf mini-screws placed in movable mucosa or attached gingiva. Angle Orthod. 2015 Nov;85(6):905-10. doi: 10.2319/092714.695.1. Epub 2015 Jan 20.
PubMed 25603272Choi SH, Jang SH, Cha JY, Hwang CJ. Evaluation of the surface characteristics of anodic oxidized miniscrews and their impact on biomechanical stability: An experimental study in beagle dogs. Am J Orthod Dentofacial Orthop. 2016 Jan;149(1):31-8. doi: 10.1016/j.ajodo.2015.06.020.
PubMed 26718375Gansukh O, Jeong JW, Kim JW, Lee JH, Kim TW. Mechanical and Histological Effects of Resorbable Blasting Media Surface Treatment on the Initial Stability of Orthodontic Mini-Implants. Biomed Res Int. 2016;2016:7520959. doi: 10.1155/2016/7520959. Epub 2016 Jan 28.
PubMed 26942200Park HJ, Choi SH, Choi YJ, Park YB, Kim KM, Yu HS. A prospective, split-mouth, clinical study of orthodontic titanium miniscrews with machined and acid-etched surfaces. Angle Orthod. 2019 May;89(3):411-417. doi: 10.2319/031618-211.1. Epub 2018 Dec 5.
PubMed 30516419
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective , Split-mouth, Clinical Study of Orthodontic Titanium Miniscrews With Machined and Acid-etched Surfaces.
- ClinicalTrials.gov ID
- NCT07662434
- Acronym / sponsor ID
- FUCDCLINIC-2406
- Conditions
- Malaligned Teeth, Crowding
- Keywords
- Miniscrews, Acid-etched Miniscrews
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 23 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.
Primary goal of this study to check the stability of miniscrews used in orthodontic treatment in order to evaluate the success of the treatment.
Detailed description
Aim of the study is to compare the success rate and primary stability of surface treated versus non-treated miniscrews. Stability of screws is the major concern for an orthodontist during treatment. Surface treatment actually modify the surface by making it rough resulting in increase in surface area which provide better stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group: Acid etcehd miniscrews | Experimental | Device: miniscrews placementPlacement of surface treated screws |
| Control Group with conventional miniscrews | Placebo comparator | Device: miniscrews placementNon-surface treated miniscrews |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Fixed appliance treatment with or without premolar extraction One or more miniscrews for same reason in each quadrant of maxilla or mandible Patient over 13 years Patient with permanent dentition\ Treatment plan should include miniscrews
Key exclusion criteria (1 listed)
- Severe craniofacial deformities such as cleft lip and palate History of bone disease Cases with high expectation of failure due to anatomical limitation such as sinus pneumatization Narrow interproximal alveolar bone Attached gingiva deficiency Mixed Dentition
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 |
|---|---|---|
| miniscrews placementPlacement of miniscrews under local anesthesia in both groups | Device | Control Group with conventional miniscrews, experimental group: Acid etcehd miniscrews |
Primary outcome
Primary Stability of of machined and acid-etched miniscrews
Time frame: After one month of insertion
Absence of clinical stability of miniscrews (>1mm)
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 1 Oct 2026.
- Results publication: PubMed 24355870Yoo SH, Park YC, Hwang CJ, Kim JY, Choi EH, Cha JY. A comparison of tapered and cylindrical miniscrew stability. Eur J Orthod. 2014 Oct;36(5):557-62. doi: 10.1093/ejo/cjt092. Epub 2013 Dec 19.
- Results publication: PubMed 17868386Chen YJ, Chang HH, Huang CY, Hung HC, Lai EH, Yao CC. A retrospective analysis of the failure rate of three different orthodontic skeletal anchorage systems. Clin Oral Implants Res. 2007 Dec;18(6):768-75. doi: 10.1111/j.1600-0501.2007.01405.x. Epub 2007 Sep 14.
- Results publication: PubMed 25603272Chang C, Liu SS, Roberts WE. Primary failure rate for 1680 extra-alveolar mandibular buccal shelf mini-screws placed in movable mucosa or attached gingiva. Angle Orthod. 2015 Nov;85(6):905-10. doi: 10.2319/092714.695.1. Epub 2015 Jan 20.
- Results publication: PubMed 26718375Choi SH, Jang SH, Cha JY, Hwang CJ. Evaluation of the surface characteristics of anodic oxidized miniscrews and their impact on biomechanical stability: An experimental study in beagle dogs. Am J Orthod Dentofacial Orthop. 2016 Jan;149(1):31-8. doi: 10.1016/j.ajodo.2015.06.020.
- Results publication: PubMed 26942200Gansukh O, Jeong JW, Kim JW, Lee JH, Kim TW. Mechanical and Histological Effects of Resorbable Blasting Media Surface Treatment on the Initial Stability of Orthodontic Mini-Implants. Biomed Res Int. 2016;2016:7520959. doi: 10.1155/2016/7520959. Epub 2016 Jan 28.
- Results publication: PubMed 30516419Park HJ, Choi SH, Choi YJ, Park YB, Kim KM, Yu HS. A prospective, split-mouth, clinical study of orthodontic titanium miniscrews with machined and acid-etched surfaces. Angle Orthod. 2019 May;89(3):411-417. doi: 10.2319/031618-211.1. Epub 2018 Dec 5.
- Individual participant dataSharing planned: No. Patient privacy
Related trials for Malaligned Teeth
Not yet recruiting
Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment
Malaligned Teeth, Crowding of Teeth
Recruiting
Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms
Malocclusion, Misaligned Teeth
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miniscrews placement in people with Malaligned Teeth and Crowding, run by Foundation University Islamabad at 1 site in Pakistan.
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 1 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: finished, as of the sponsor's last update on 1 Oct 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Primary Stability of of machined and acid-etched miniscrews (time frame: After one month of insertion). 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 NCT07662434, which also lists 6 linked publications.
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 1 Oct 2026.