Actively Recruiting

Phase Not Applicable
Age: 16Years - 20Years
All Genders
Healthy Volunteers
NCT07105969

Strontium-Hydroxyapatite Coated Mini-Screws: Antibacterial Effect and Stability

Led by Mansoura University · Updated on 2025-08-26

20

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized controlled clinical trial aims to evaluate the antibacterial efficacy and stability of strontium-incorporated hydroxyapatite (Sr-HA) coated orthodontic mini-screws (OMSs) used for maxillary canine retraction. A double-blind, split-mouth design was employed, involving 20 patients (aged 16-20 years), each receiving two titanium alloy mini-screws (1.6 mm × 8 mm): one coated with Sr-HA (5% concentration via electrochemical deposition) and one uncoated control. A total of 40 mini-screws were assessed. Following upper first premolar extractions, canine retraction was initiated using 150 g NiTi coil springs on 17×25 SS archwires. Mini-screws were placed between the upper second premolar and first molar without flap elevation or pilot hole drilling. Parameters including screw stability, antimicrobial activity, and gingival blood flow were monitored over a 4-month period. The incorporation of Sr-HA is hypothesized to enhance mini-screw osseointegration, reduce peri-implant inflammation, and improve clinical outcomes by leveraging the osteogenic and antibacterial properties of strontium. This study aims to provide evidence supporting the use of Sr-HA coatings to reduce mini-screw failure rates in orthodontic treatment.

CONDITIONS

Official Title

Strontium-Hydroxyapatite Coated Mini-Screws: Antibacterial Effect and Stability

Who Can Participate

Age: 16Years - 20Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 16 to 20 years
  • Orthodontic treatment plan requiring extraction of upper first premolars
  • Fully erupted permanent teeth (excluding third molars)
  • No previous orthodontic treatment
  • No medical problems that could interfere with treatment
Not Eligible

You will not qualify if you...

  • Problematic healing conditions such as compromised immune defense, bleeding disorders, poor bone quality, or dry mouth
  • Inadequate oral hygiene
  • Heavy smoking

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt, 35516

Actively Recruiting

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Research Team

H

Hind H jasim Al-khazrajy, Bachelors

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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