Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles

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.

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Combination product: Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles; Combination product: Uncoated Miniscrew with Chlorhexidine Hexametaphosphate 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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq
    • University of Baghdad College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Undergoing orthodontic treatment by fixed orthodontic appliance.
• Indicated for a bilateral miniscrews.
• Good oral hygiene.

Exclusion Criteria:

• Medically compromised patients.
• Heavy smoker.
• Dry mouth ( Xerostomia).
• mucogingival lesions.
• Patients with chlorhexidine allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles; 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.
Active Comparator: 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.	Combination product: Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles; Non-coated orthodontic miniscrews

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	for 4 month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	each month for 3 month.

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Director: Akram F. Alhuwaizi, Prof., akramalhuwaizi@codental.uobaghdad.edu.iq

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): November 12, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Success Rate; Pain Perception; Orthodontic miniscrew; Miniscrew Mobility; Peri-implant health; Coated miniscrew; Coated Mini-implant; Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: Coated Orthodontic Miniscrews

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be mostly available on request.
• IPD Sharing Time Frame: 1/11/2024 If not affected on publishing of may article for 3 month can i share this information
• IPD Sharing Access Criteria: I can provide data as word or excel.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No