Class I MalocclusionNCT07521267
Nano Coated Orthodontic Miniscrews for en Mass Retraction of the Upper Arch
A study testing Silver nanoparticles and uncoated titanium miniscrews in people with Class I Malocclusion and Maxillary Prognathism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
study will be directed to evaluate silver-hydroxyapatite nano-coated versus uncoated orthodontic miniscrews for en masse retraction of the upper anterior segment. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Class I Malocclusion, Maxillary Prognathism, Orthodontic Tooth Movement
- What is being tested?
- Silver nanoparticles and uncoated titanium miniscrews
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Nov 2029
- 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Class I orthodontic cases with bimaxillary protrusion of the anterior segment of the upper jaw that need at least extraction for orthodontic treatment.
- Age 14-20 years.
- Good oral hygiene with healthy periodontium.
- Need for an absolute skeletal anchorage.
- Systemically healthy patients.
Who cannot join
- Patient with craniofacial anomalies (e.g, cleft lip and palate)
- Presence of systemic diseases or syndromes affecting bone metabolism (e.g, osteoporosis, rickets)
- Poor oral hygiene or uncooperative patients.
- Extensive dental caries or untreated periodontal disease.
- History of trauma or surgery affecting the maxilla or mandible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine (Boys), Al-Azhar University
Cairo, Cairo Governorate, 4434103
Hashem Kh Al-Washali, MScCandidate, +01120042296, Hashemalwashali.2.209@azhar.edu.eg
Mahmoud Fa Aboelmahasen, Phd, +01222993381, MahmoudFathy.209@azhar.edu.eg
About this study
Official title: Evaluation of Silver-Hydroxyapatite Nano-coated Versus Uncoated Orthodontic Miniscrews for en Masse Retraction of the Upper Anterior Segment: A Randomized Clinical Trial
study will be directed to evaluate silver-hydroxyapatite nano-coated versus uncoated orthodontic miniscrews for en masse retraction of the upper anterior segment.
Read the detailed description
Silver-hydroxyapatite nanoparticles (Ag-HA NPs) have lately gained popularity in dentistry due to their unique combination of silver antibacterial activity and hydroxyapatite's osteoconductive, remineralizing characteristics. Ag-HA has shown potential in resolving two important clinical issues: infection control and anchoring stability. Coating orthodontic miniscrews with Ag-HA NPs has been demonstrated to reduce peri-implant biofilm growth by their antimicrobial effect, minimizing inflammation, and increasing osseointegration, thus increasing the long-term success of temporary anchoring devices (TADs).
- Being tested
- Silver nanoparticles, uncoated titanium miniscrews
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver nanoparticlesDevice
Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews.These miniscrews will be placed in the maxillary bone for en masse retractonof the upper anterior teeth.
uncoated titanium miniscrewsDevice
Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as the intervention of the group1, but without nano-coating.
| Study group | Role | What they receive |
|---|---|---|
| silver-hydroxyapatite nanocoated titanium miniscrews | Experimental | Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews. These miniscrews will be placed in the maxillary bone for en masse retraction of the upper anterior teeth. Receives: Device: Silver nanoparticles |
| uncoated titanium miniscrews | Active comparator | Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as Arm 1, but without nano-coating. Receives: Device: uncoated titanium miniscrews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction
Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction
Measured: about 6 months
Secondary outcomes (1)
Assessment of the rate of en masse retraction of the anterior segment of the upper arch
Assessment of the rate of en masse retraction of the anterior segment of the upper arch.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class I MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashem Khalil Saleh Mohammed, Al-Azhar University
- Investigators
- Mahmoud FA Aboelmahasen, Phd, Study director, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, EgyptAhmed Ak El-Awady, Phd, Study director, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521267
- Sponsor's protocol ID
- nano-coated ortho-miniscrew
- Other IDs
- EC Ref 1344/765
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Will not be Shared Due to Privacy Consideration.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Silver-Hydroxyapatite Nano-coated Versus Uncoated Orthodontic Miniscrews for en Masse Retraction of the Upper Anterior Segment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07521267
- Acronym / sponsor ID
- nano-coated ortho-miniscrew
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 9 Apr 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.
study will be directed to evaluate silver-hydroxyapatite nano-coated versus uncoated orthodontic miniscrews for en masse retraction of the upper anterior segment.
Detailed description
Silver-hydroxyapatite nanoparticles (Ag-HA NPs) have lately gained popularity in dentistry due to their unique combination of silver antibacterial activity and hydroxyapatite's osteoconductive, remineralizing characteristics. Ag-HA has shown potential in resolving two important clinical issues: infection control and anchoring stability. Coating orthodontic miniscrews with Ag-HA NPs has been demonstrated to reduce peri-implant biofilm growth by their antimicrobial effect, minimizing inflammation, and increasing osseointegration, thus increasing the long-term success of temporary anchoring devices (TADs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silver-hydroxyapatite nanocoated titanium miniscrews | Experimental | Device: Silver nanoparticlesPatients will receive silver-hydroxyapatite nanocoated titanium miniscrews. These miniscrews will be placed in the maxillary bone for en masse retraction of the upper anterior teeth. |
| uncoated titanium miniscrews | Active comparator | Device: uncoated titanium miniscrewsPatients will receive conventional uncoated titanium miniscrews of the same dimensions and design as Arm 1, but without nano-coating. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Class I orthodontic cases with bimaxillary protrusion of the anterior segment of the upper jaw that need at least extraction for orthodontic treatment.
- Age 14-20 years.
- Good oral hygiene with healthy periodontium.
- Need for an absolute skeletal anchorage.
- Systemically healthy patients.
Key exclusion criteria (5 listed)
- Patient with craniofacial anomalies (e.g, cleft lip and palate)
- Presence of systemic diseases or syndromes affecting bone metabolism (e.g, osteoporosis, rickets)
- Poor oral hygiene or uncooperative patients.
- Extensive dental caries or untreated periodontal disease.
- History of trauma or surgery affecting the maxilla or mandible.
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 |
|---|---|---|
| Silver nanoparticlesPatients will receive silver-hydroxyapatite nanocoated titanium miniscrews.These miniscrews will be placed in the maxillary bone for en masse retractonof the upper anterior teeth. | Device | silver-hydroxyapatite nanocoated titanium miniscrews |
| uncoated titanium miniscrewsPatients will receive conventional uncoated titanium miniscrews of the same dimensions and design as the intervention of the group1, but without nano-coating. | Device | uncoated titanium miniscrews |
Primary outcome
Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction
Time frame: about 6 months
Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction
1 secondary outcome
Assessment of the rate of en masse retraction of the anterior segment of the upper arch
Time frame: 6 months
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 13 Apr 2026.
- Individual participant dataSharing planned: No. Data Will not be Shared Due to Privacy Consideration.
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Diode Laser Versus LED for Maxillary Canine Retraction in Orthodontic Patients
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Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite
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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.
Mahmoud FA Aboelmahasen, Phd study director
Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt
Ahmed Ak El-Awady, Phd study director
Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver nanoparticles and uncoated titanium miniscrews in people with Class I Malocclusion and Maxillary Prognathism, run by Al-Azhar University at 1 site in Egypt.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 Egypt. 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?
Contact Hashem Kh Al-Washali, MScCandidate (+01120042296, Hashemalwashali.2.209@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction (time frame: about 6 months). 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 13 Apr 2026.