Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles
NCT ID: NCT06124235
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
39 participants
INTERVENTIONAL
2023-02-10
2023-12-20
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Coated Miniscrew
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.
Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles
insertion:
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.
Uncoated Miniscrew
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.
Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles
Non-coated orthodontic miniscrews
Interventions
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Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles
insertion:
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.
Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles
Non-coated orthodontic miniscrews
Eligibility Criteria
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Inclusion Criteria
* Indicated for a bilateral miniscrews.
* Good oral hygiene.
Exclusion Criteria
* Heavy smoker.
* Dry mouth ( Xerostomia).
* mucogingival lesions.
* Patients with chlorhexidine allergy.
13 Years
ALL
Yes
Sponsors
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University of Baghdad
OTHER
Responsible Party
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Ahmed Ali Abbas
Bachelor's dental Surgery ( B. D. S)
Principal Investigators
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Locations
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University of Baghdad College of Dentistry
Baghdad, , Iraq
Countries
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References
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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.
Other Identifiers
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Coated Orthodontic Miniscrews
Identifier Type: -
Identifier Source: org_study_id