Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles

NCT06124235 | Completed Phase 3

• 1 other identifier: Coated Orthodontic Miniscrews
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Aim To compare between orthodontic miniscrews coated and uncoated with CHX- HMP NP nanoparticles.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparing the peri-implant health around coated and uncoated miniscrews.

  each month for 3 month.

• Comparing pain perception between coated and uncoated miniscrews.

  1 day, 2 day, 3 day, 4 day, 5 day, 6 day, and 7 day.

• Comparing the miniscrew mobility between coated and uncoated miniscrews.

  each month for 3 month.

Study Arms (2)

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.

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.

Combination Product: Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles

Interventions

Coated Orthodontic Miniscrews with Chlorhexidine Hexametaphosphate Nanoparticles COMBINATION_PRODUCT

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.

Coated Miniscrew

Uncoated Miniscrew with Chlorhexidine Hexametaphosphate Nanoparticles COMBINATION_PRODUCT

Non-coated orthodontic miniscrews

Uncoated Miniscrew

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad College of Dentistry

Baghdad, Iraq

Location

Related Publications (1)

• 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.

  PMID: 39521698 DERIVED

Study Officials

• Akram F. Alhuwaizi, Prof.

  akramalhuwaizi@codental.uobaghdad.edu.iq

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor's dental Surgery ( B. D. S)

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 9, 2023
• Study Start: February 10, 2023
• Primary Completion: November 12, 2023
• Study Completion: December 20, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1/11/2024 If not affected on publishing of may article for 3 month can i share this information
• Access Criteria: I can provide data as word or excel.

Locations

IR (1)