NCT07105969 Strontium-Hydroxyapatite Coated Mini-Screws: Antibacterial Effect and Stability
| NCT ID | NCT07105969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mansoura University |
| Condition | Gingival Inflammation and Loss the Orthodontic Mini-screws |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2026-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-05-14 with a primary completion date of 2026-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adult patients within an age range (16-20) years. 2. Orthodontic treatment plan requiring the extraction of the upper first premolars. 3. Patients have fully permanent teeth are erupted (third molars are not included). 4. No previous orthodontic treatment 5. No medical problem that could interfere with treatment. Exclusion Criteria: 1. Presence of problematic healing such as, compromised immune defense, bleeding disorder, pathological bone quality, and xerostomia. 2. Inadequate oral hygiene. 3. Heavy smoking
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07105969 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 20 Years, studying Gingival Inflammation and Loss the Orthodontic Mini-screws. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07105969 currently recruiting?
Yes, NCT07105969 is actively recruiting participants. Contact the research team at hindhhjk@gmail.com for enrollment information.
Where is the NCT07105969 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT07105969 clinical trial?
NCT07105969 is sponsored by Mansoura University. The trial plans to enroll 20 participants.