Nano Coated Orthodontic Miniscrews for en Mass Retraction of the Upper Arch

Evaluation of Silver-Hydroxyapatite Nano-coated Versus Uncoated Orthodontic Miniscrews for en Masse Retraction of the Upper Anterior Segment: A Randomized Clinical Trial

study will be directed to evaluate silver-hydroxyapatite nano-coated versus uncoated orthodontic miniscrews for en masse retraction of the upper anterior segment.

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Tooth Movement; Class I Malocclusion; Maxillary Prognathism
• Intervention / Treatment: Device: Silver nanoparticles; Device: uncoated titanium miniscrews

Detailed Description

Silver-hydroxyapatite nanoparticles (Ag-HA NPs) have lately gained popularity in dentistry due to their unique combination of silver antibacterial activity and hydroxyapatite's osteoconductive, remineralizing characteristics. Ag-HA has shown potential in resolving two important clinical issues: infection control and anchoring stability. Coating orthodontic miniscrews with Ag-HA NPs has been demonstrated to reduce peri-implant biofilm growth by their antimicrobial effect, minimizing inflammation, and increasing osseointegration, thus increasing the long-term success of temporary anchoring devices (TADs).

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hashem Kh Al-Washali, MScCandidate; Phone Number: +01120042296; Email: Hashemalwashali.2.209@azhar.edu.eg
• Study Contact Backup: Name: Mahmoud FA Aboelmahasen, Phd; Phone Number: +01222993318; Email: MahmoudFathy.209@azhar.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 4434103
      • Recruiting
      • Faculty of Dental Medicine (Boys), Al-Azhar University
      • Contact: Hashem Kh Al-Washali, MScCandidate; Phone Number: +01120042296; Email: Hashemalwashali.2.209@azhar.edu.eg
      • Contact: Mahmoud Fa Aboelmahasen, Phd; Phone Number: +01222993381; Email: MahmoudFathy.209@azhar.edu.eg
      • Principal Investigator: Hashem Kh Al-Washali, MScCandidate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Class I orthodontic cases with bimaxillary protrusion of the anterior segment of the upper jaw that need at least extraction for orthodontic treatment.
• Age 14-20 years.
• Good oral hygiene with healthy periodontium.
• Need for an absolute skeletal anchorage.
• Systemically healthy patients.

Exclusion Criteria:

• Patient with craniofacial anomalies (e.g, cleft lip and palate)
• Presence of systemic diseases or syndromes affecting bone metabolism (e.g, osteoporosis, rickets)
• Poor oral hygiene or uncooperative patients.
• Extensive dental caries or untreated periodontal disease.
• History of trauma or surgery affecting the maxilla or mandible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: silver-hydroxyapatite nanocoated titanium miniscrews; Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews. These miniscrews will be placed in the maxillary bone for en masse retraction of the upper anterior teeth.	Device: Silver nanoparticles; Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews.These miniscrews will be placed in the maxillary bone for en masse retractonof the upper anterior teeth.
Active Comparator: uncoated titanium miniscrews; Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as Arm 1, but without nano-coating.	Device: uncoated titanium miniscrews; Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as the intervention of the group1, but without nano-coating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction	Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction	about 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the rate of en masse retraction of the anterior segment of the upper arch	Assessment of the rate of en masse retraction of the anterior segment of the upper arch.	6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Mahmoud FA Aboelmahasen, Phd, Faculty of Dental medicine (Boys), Al-Azhar University, Cairo, Egypt; Study Director: Ahmed Ak El-Awady, Phd, Faculty of Dental medicine (Boys), Al-Azhar University, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class I
• Other Study ID Numbers: nano-coated ortho-miniscrew; EC Ref 1344/765 (Other Identifier: Al-Azhar University Institutional Review Board (IRB))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data Will not be Shared Due to Privacy Consideration.

Drug and device information, study documents

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