NCT06124235

Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles

Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles (A Randomized Clinical Trial)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Accepted

Summary

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?

Conditions

• Orthodontic Appliance Complication

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
COMBINATION_PRODUCT	Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles	Non-coated orthodontic miniscrews

Timeline

• Start date: 2023-02-10
• Primary completion: 2023-11-12
• Completion: 2023-12-20
• First posted: 2023-11-09
• Last updated: 2023-12-29

Locations

1 site across 1 country: Iraq