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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-14

Study Completion Date

2026-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of Coated Orthodontic Miniscrews With Chlorhexidine Hexametaphosphate Antimicrobial Nanoparticles

NCT06124235

Orthodontic Appliance Complication

COMPLETED PHASE3

Assessment of the Rate of Oseointegration Surrounding Nano-coated Orthodontic Titanium Miniscrew

NCT05898724

Health Care Utilization Diet, Healthy Frey Syndrome

COMPLETED NA

Evaluation of the Levels of Pain and Discomfort and Periodontal Status Between Two Acceleration Methods of Upper Anterior Teeth Retraction

NCT05656898

Class II Malocclusion

COMPLETED NA

Success Rate of the Miniscrews in the Mandibular Buccal Shelf

NCT05280678

Class III Malocclusion

COMPLETED NA

Acceleration of Orthodontic Tooth Movement

NCT05560919

Mild to Moderate Anterior Mandibular Segment Crowdind

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aim of the study:

The aim of this study is to evaluate the antibacterial efficacy and stability of strontium- incorporated hydroxyapatite (Sr-HA) coated orthodontic mini- screws used in maxillary canine retraction in comparison to uncoated mini- screws.

Material and methods:

1. All patients will be treatment with fixed appliance and Roth type brackets where leveling and alignment will be done utilizing nickel titanium.
2. Extraction the upper first premolars and retraction the canine will be done using 17 ×25 SS wire.
3. A periapical X-ray will be taken to confirm the mini screw position to avoid interference with adjacent root and to ensure that there are no periapical lesion.
4. Symmetrical orthodontic miniscrews will be inserted between the second premolar and first molar.
5. The OMSs that will be used in this study will be self-drilling, conical in shape, 1.6 mm in diameter, and 8 mm in length, constructed of titanium alloy, i well be purchased from Dentaurum company \[Germany\].
6. The orthodontic main screws were loaded with a 150 g NiTi coil spring.
7. On one side, a coated will be inserted, and on the other side, an uncoated will be used for the same patient.
8. Coated materials will utilize \[Strontium incorporated hydroxyapatite\] applied by electrochemical deposition and concentration percentage about 5 % .
9. No mucoperiosteal flap will be raised, and no pilot hole will be made during the procedure.
10. Will be assessed throughout follow-up periods of up to four months.

Outcome Measurement:

1. Assessment Orthodontic mini-screws stability (coated and uncoated) using Periotest device .
2. Evaluate antimicrobial effect of Strontium incorporated Hydroxyapatite using Enzem- Linked Immunosorbent technique .
3. Evaluate blood flow by periodental probe.
4. Gingival health by visual assessment .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingival Inflammation and Loss the Orthodontic Mini-screws

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 : uncoated OMSs.

Mini- screw uncoated by Sr-HA

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2: coated OMSs by Sr-HA

Mini-screw coated by Sr-HA

Group Type EXPERIMENTAL

Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum company

Intervention Type OTHER

Maxillary canine retraction by mini-screw loaded with 150g Niti coil spring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum company

Maxillary canine retraction by mini-screw loaded with 150g Niti coil spring

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mini -screw stability

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes