Orthodontic Appliance ComplicationPhase 3NCT06124235
Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles
A Phase 3 study testing Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles and Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles in people with Orthodontic Appliance Complication, run by University of Baghdad at 1 site in Iraq.
Trial summary
Aim To compare between orthodontic miniscrews coated and uncoated with CHX- HMP NP nanoparticles. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles and Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteIraq
- Study dates
- 10 Feb 2023to 20 Dec 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Undergoing orthodontic treatment by fixed orthodontic appliance.
- Indicated for a bilateral miniscrews.
- Good oral hygiene.
Who cannot join
- Medically compromised patients.
- Heavy smoker.
- Dry mouth ( Xerostomia).
- mucogingival lesions.
- Patients with chlorhexidine allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles (A Randomized Clinical Trial)
Aim To compare between orthodontic miniscrews coated and uncoated with CHX- HMP NP nanoparticles.
Read the detailed description
Anchorage management by using of OMS to give anchoring for force application made using several orthodontic treatment techniques simple and improved their efficacy , because anchorage control is a challenge throughout the orthodontic treatment process till temporary orthodontic anchorage devices have been developed. Although stainless steel (SS) screws were initially introduced, the majority of currently presented OMS are manufactured from titanium (purity grades I to IV). Because they offer greater mechanical strength and reduce the danger of fracture during insertion and removal, titanium alloy miniscrews are typically employed. Failure of these devices is the most frequent issue related to the usage of OMSs. The development of a biofilm on these devices that causes periimplantitis is one of the recognized reasons for failure.
Primary stability (mechanical stability) is awarded shortly after the placement procedure of the device and secondary stability (biological stability) initiates at the placement time and enhances during the process of healing or bone remodeling. The first 8 weeks after insertion, during which time the stability of the implant transitions from mechanical to biological stability, are when OMS failure occurs most frequently. Although failure might be prevented by following the right protocols of treatment, the fact that, rate of failure of OMS could not be overlooked. The miniscrew's mobility and displacement, together with an infection of the soft tissues around, are causes of failure. Unmodified titanium and its alloys are prone to bacterial infections which lead to inflammation and failure of the implant eventually. Prevention of bacterial adhesion may inhibit biofilm formation.
Antibiotics used for protection against implant infection postoperatively is debatable due to inducing the process of antimicrobial resistance, substitute techniques to avoid this must be inspected. There are three recent solutions that have the ability to prevent the formation of biofilm on miniimplant surfaces. These include altering the topography of surfaces to prevent bacterial adhesion, treating surfaces with antimicrobial releasing agents for a set period of time to prevent bacterial adhesion, as well as eliminating bacteria nearby, and, finally, coating surfaces with antimicrobial agents that prevent attachment of bacteria over an extended period of time. The previous study on human dermal fibroblast of neonate cells showed that both coated and uncoated titanium OMSs were non-cytotoxic, furthermore, the animal study showed enhanced bone-remodeling process.
The research question is 'Does coating orthodontic mini-screws with CHX-HMP NPs increase their success rate?
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles, Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles
- Keywords
- Orthodontic miniscrew, Success Rate, Miniscrew Mobility, Pain Perception, Peri-implant health, Coated miniscrew, Coated Mini-implant, Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate NanoparticlesCombination product
insertion:
- According to the random number generated, the corresponding envelop for left and right side by chosen.
- The patient will be asked to brush his/her teeth.
- The patient will rinse his/her mouth with chlorhexidine mouth rinse (0.12%) just before surgery being at least half an hour after brushing.
The miniscrews used conical shaped, self-drilling, 1.6 mm in diameter, 8mm in length made of Ti.
- The site of insertion determined from the x-ray by using stent that will be fabricated for accurate site for OMS.
- Infiltration LA will be administered. Approximately 0.45 mL ,injected into the alveolar mucosa above the OMS placement site, in order to provides an acceptable anesthesia, while still allowing the patient feedback in case the OMS contacting the periodontal ligament (PDL).
- OMS will be placed manually by screw driver on buccally at an angle 90 degrees and then adjusted to the appropriate angle.
- x-ray will be taken to confirm OMS position.
Uncoated Miniscrew with Chlorhexidine Hexametaphosphate NanoparticlesCombination product
Non-coated orthodontic miniscrews
| Study group | Role | What they receive |
|---|---|---|
| Coated Miniscrew | Experimental | Device Place stent for accurate position of miniscrew, x-ray, inserting miniscrew, xray for showing position of miniscrew, then use Visual analoge scale for pain assessment for first 7 days, peri-implant health and mobility check each month for 3 month and success rate after 4 month. Receives: Combination Product: Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles |
| Uncoated Miniscrew | Active comparator | Device Place stent for accurate position of miniscrew, x-ray, inserting miniscrew, xray for showing position of miniscrew, then use Visual analoge scale for pain assessment for first 7 days, peri-implant health and mobility check each month for 3 month and success rate after 4 month. Receives: Combination Product: Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the success rate of coated and uncoated miniscrews.
Orthodontic mini-screw will be considered successful when it could be loaded with orthodontic forces and fulfill its anchorage objectives without pain, gingival growth cover the head of miniscrew and fracture of miniscrew.
Measured: for 4 month.
Secondary outcomes (3)
Comparing the peri-implant health around coated and uncoated miniscrews.
The absence versus presence of peri-implantitis was evaluated by means of periodontal visual inspection. When the keratinized gingiva were normal (i.e., they had a pink color, no edema or tissue growth, and no spontaneous bleeding), they were given a score of 0 (absence of peri-implantitis). A score of 1 was used to indicate mild peri-implantitis (i.e., the keratinized gingiva around the MI exhibited a color alteration, with a small volumetric increase, but not covering the MI head base, and without spontaneous bleeding. A score of 2 was used to indicate severe peri-implantitis, with the keratinized gingiva showing a color change, spontaneous bleeding, and gingival hyperplasia covering the MI head base. Finally, larger gingival hyperplasia covering part or all of the MI's head were given a score of 3. Normally, in the latter situation, the gingiva also presented with a color change and spontaneous bleeding.
Measured: each month for 3 month.
Comparing pain perception between coated and uncoated miniscrews.
The patients will be given a sheet contain VAS scale and will be informed about how to use it. They will be told that zero in VAS corresponds to no pain and 10 corresponds to maximum pain, and will be asked to document their perceived pain intensity accordingly. Pain perception will be recorded after TAD insertion by 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, and 7 day.
Measured: 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, and 7 day.
Comparing the miniscrew mobility between coated and uncoated miniscrews.
MI mobility was classified using 4 scores: a score of 0 was given when there was no movement of the MI. When there was a small amount of mobility of the MI, but without tissue ischemia, it was classified with score of 1 (exhibiting mobility but fulfilling its function). Moderate displacement of the MI causing tissue ischemia was classified with score of 2 (exhibiting displacement but fulfilling its function). Finally, a score of 3 was used when mobility was excessive, to the point of preventing the MI from maintaining anchorage.
Measured: each month for 3 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start10 Feb 2023
- Primary completion12 Nov 2023
- Study completion20 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Abbas, University of Baghdad
- Investigators
- Akram F. Alhuwaizi, Prof., Study director, akramalhuwaizi@codental.uobaghdad.edu.iq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124235
- Sponsor's protocol ID
- Coated Orthodontic Miniscrews
- Status last verified
- Dec 2023
- First submitted
- 19 Oct 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be mostly available on request.
Publications
Al-Hilaly AA, Alhuwaizi AF. Assessment of coated orthodontic miniscrews with chlorhexidine hexametaphosphate antimicrobial nanoparticles: A randomized clinical trial. J World Fed Orthod. 2025 Apr;14(2):67-75. doi: 10.1016/j.ejwf.2024.09.006. Epub 2024 Nov 8.
PubMed 39521698
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06124235
- Acronym / sponsor ID
- Coated Orthodontic Miniscrews
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Orthodontic miniscrew, Success Rate, Miniscrew Mobility, Pain Perception, Peri-implant health, Coated miniscrew, Coated Mini-implant, Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 9 Nov 2023 (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.
Aim To compare between orthodontic miniscrews coated and uncoated with CHX- HMP NP nanoparticles.
Detailed description
Anchorage management by using of OMS to give anchoring for force application made using several orthodontic treatment techniques simple and improved their efficacy , because anchorage control is a challenge throughout the orthodontic treatment process till temporary orthodontic anchorage devices have been developed. Although stainless steel (SS) screws were initially introduced, the majority of currently presented OMS are manufactured from titanium (purity grades I to IV). Because they offer greater mechanical strength and reduce the danger of fracture during insertion and removal, titanium alloy miniscrews are typically employed. Failure of these devices is the most frequent issue related to the usage of OMSs. The development of a biofilm on these devices that causes periimplantitis is one of the recognized reasons for failure.
Primary stability (mechanical stability) is awarded shortly after the placement procedure of the device and secondary stability (biological stability) initiates at the placement time and enhances during the process of healing or bone remodeling. The first 8 weeks after insertion, during which time the stability of the implant transitions from mechanical to biological stability, are when OMS failure occurs most frequently. Although failure might be prevented by following the right protocols of treatment, the fact that, rate of failure of OMS could not be overlooked. The miniscrew's mobility and displacement, together with an infection of the soft tissues around, are causes of failure. Unmodified titanium and its alloys are prone to bacterial infections which lead to inflammation and failure of the implant eventually. Prevention of bacterial adhesion may inhibit biofilm formation.
Antibiotics used for protection against implant infection postoperatively is debatable due to inducing the process of antimicrobial resistance, substitute techniques to avoid this must be inspected. There are three recent solutions that have the ability to prevent the formation of biofilm on miniimplant surfaces. These include altering the topography of surfaces to prevent bacterial adhesion, treating surfaces with antimicrobial releasing agents for a set period of time to prevent bacterial adhesion, as well as eliminating bacteria nearby, and, finally, coating surfaces with antimicrobial agents that prevent attachment of bacteria over an extended period of time. The previous study on human dermal fibroblast of neonate cells showed that both coated and uncoated titanium OMSs were non-cytotoxic, furthermore, the animal study showed enhanced bone-remodeling process.
The research question is 'Does coating orthodontic mini-screws with CHX-HMP NPs increase their success rate?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coated Miniscrew | Experimental | Combination Product: Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate NanoparticlesDevice Place stent for accurate position of miniscrew, x-ray, inserting miniscrew, xray for showing position of miniscrew, then use Visual analoge scale for pain assessment for first 7 days, peri-implant health and mobility check each month for 3 month and success rate after 4 month. |
| Uncoated Miniscrew | Active comparator | Combination Product: Uncoated Miniscrew with Chlorhexidine Hexametaphosphate NanoparticlesDevice Place stent for accurate position of miniscrew, x-ray, inserting miniscrew, xray for showing position of miniscrew, then use Visual analoge scale for pain assessment for first 7 days, peri-implant health and mobility check each month for 3 month and success rate after 4 month. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing orthodontic treatment by fixed orthodontic appliance.
- Indicated for a bilateral miniscrews.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Medically compromised patients.
- Heavy smoker.
- Dry mouth ( Xerostomia).
- mucogingival lesions.
- Patients with chlorhexidine allergy.
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 |
|---|---|---|
| Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticlesinsertion: 1. According to the random number generated, the corresponding envelop for left and right side by chosen. 2. The patient will be asked to brush his/her teeth. 3. The patient will rinse his/her mouth with chlorhexidine mouth rinse (0.12%) just before surgery being at least half an hour after brushing. The miniscrews used conical shaped, self-drilling, 1.6 mm in diameter, 8mm in length made of Ti. 1. The site of insertion determined from the x-ray by using stent that will be fabricated for accurate site for OMS. 2. Infiltration LA will be administered. Approximately 0.45 mL ,injected into the alveolar mucosa above the OMS placement site, in order to provides an acceptable anesthesia, while still allowing the patient feedback in case the OMS contacting the periodontal ligament (PDL). 3. OMS will be placed manually by screw driver on buccally at an angle 90 degrees and then adjusted to the appropriate angle. 4. x-ray will be taken to confirm OMS position. | Combination product | Coated Miniscrew |
| Uncoated Miniscrew with Chlorhexidine Hexametaphosphate NanoparticlesNon-coated orthodontic miniscrews | Combination product | Uncoated Miniscrew |
Primary outcome
Compare the success rate of coated and uncoated miniscrews.
Time frame: for 4 month.
Orthodontic mini-screw will be considered successful when it could be loaded with orthodontic forces and fulfill its anchorage objectives without pain, gingival growth cover the head of miniscrew and fracture of miniscrew.
3 secondary outcomes
Comparing the peri-implant health around coated and uncoated miniscrews.
Time frame: each month for 3 month.
Comparing pain perception between coated and uncoated miniscrews.
Time frame: 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, and 7 day.
Comparing the miniscrew mobility between coated and uncoated miniscrews.
Time frame: each month for 3 month.
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 29 Dec 2023.
- Derived from this study: PubMed 39521698Al-Hilaly AA, Alhuwaizi AF. Assessment of coated orthodontic miniscrews with chlorhexidine hexametaphosphate antimicrobial nanoparticles: A randomized clinical trial. J World Fed Orthod. 2025 Apr;14(2):67-75. doi: 10.1016/j.ejwf.2024.09.006. Epub 2024 Nov 8.
- Individual participant dataSharing planned: Yes. It will be mostly available on request.
Related trials for Orthodontic Appliance Complication
Recruiting
Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
Fixed Orthodontic Retainer, Orthodontic Appliances, Removable
Recruiting
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
White Spot Lesions, Orthodontic Appliance Complication
Recruiting
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Orthodontic Appliance, Pain
Not yet recruiting
Comparison of a 3-step Bonding System (Transbond™ XT) and a 2-step System (GC Ortho Connect™) on Demineralization Around Maxillary Orthodontic Brackets
Tooth Demineralization, White Spot Lesion
Recruiting
Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
Orthodontic Appliances, Removable, Orthodontic Appliance Complication
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.
Akram F. Alhuwaizi, Prof. study director
akramalhuwaizi@codental.uobaghdad.edu.iq
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles and Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles 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 3 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: finished, as of the sponsor's last update on 29 Dec 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Compare the success rate of coated and uncoated miniscrews. (time frame: for 4 month.). 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 NCT06124235, 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 29 Dec 2023.