Gingival Inflammation and Loss the Orthodontic Mini-screwsNCT07105969
Strontium-Hydroxyapatite Coated Mini-Screws: Antibacterial Effect and Stability
A study testing Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum company in people with Gingival Inflammation and Loss the Orthodontic Mini-screws, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation and Loss the Orthodontic Mini-screws
- What is being tested?
- Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum company
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2025to 14 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adult patients within an age range (16-20) years.
- Orthodontic treatment plan requiring the extraction of the upper first premolars.
- Patients have fully permanent teeth are erupted (third molars are not included).
- No previous orthodontic treatment
- No medical problem that could interfere with treatment.
Who cannot join
- Presence of problematic healing such as, compromised immune defense, bleeding disorder, pathological bone quality, and xerostomia.
- Inadequate oral hygiene.
- Heavy smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Stability the Antibacterial Efficacy and of Strontium Incorporated Hydroxyapatite [Sr-HA] Coated Mini-screws Used for Maxillary Canine Retraction: A Randomized Clinical Trial
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.
Read the detailed description
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:
- All patients will be treatment with fixed appliance and Roth type brackets where leveling and alignment will be done utilizing nickel titanium.
- Extraction the upper first premolars and retraction the canine will be done using 17 ×25 SS wire.
- 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.
- Symmetrical orthodontic miniscrews will be inserted between the second premolar and first molar.
- 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].
- The orthodontic main screws were loaded with a 150 g NiTi coil spring.
- On one side, a coated will be inserted, and on the other side, an uncoated will be used for the same patient.
- Coated materials will utilize [Strontium incorporated hydroxyapatite] applied by electrochemical deposition and concentration percentage about 5 % .
- No mucoperiosteal flap will be raised, and no pilot hole will be made during the procedure.
- Will be assessed throughout follow-up periods of up to four months.
Outcome Measurement:
- Assessment Orthodontic mini-screws stability (coated and uncoated) using Periotest device .
- Evaluate antimicrobial effect of Strontium incorporated Hydroxyapatite using Enzem- Linked Immunosorbent technique .
- Evaluate blood flow by periodental probe.
- Gingival health by visual assessment .
- Being tested
- Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum company
- Keywords
- ▪️Sr-HA ▪️Mini-screw stability ▪️Antibacterial afficacy
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum companyOther
Also called Mini -screw stability
Maxillary canine retraction by mini-screw loaded with 150g Niti coil spring
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : uncoated OMSs. | No intervention | Mini- screw uncoated by Sr-HA |
| Group 2: coated OMSs by Sr-HA | Experimental | Mini-screw coated by Sr-HA Receives: Other: Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum company |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic mini-screws stability
Mean value of orthodontic mini-screw stability assessed using the Periotest device
Measurement Tool: A Periotest device (manufactured by Medizintechnik Gulden, Germany) will be used to evaluate the mechanical stability of the orthodontic mini-screws.
Unit of Measure: Periotest Values (PTV), expressed as numerical values ranging from -8 (high stability) to +50 (low stability).
Assessment Method: The stability of both coated (Strontium-incorporated Hydroxyapatite) and uncoated orthodontic mini-screws will be measured and compared at specific time intervals throughout the study period.
Measured: Four mounth
Secondary outcomes (1)
Anti microbial effect
Mean concentration of bacterial adhesion on orthodontic mini-screw surfaces assessed by Enzyme-Linked Immunosorbent Assay
Measurement Tool: Enzyme-Linked Immunosorbent Assay (ELISA) will be employed to quantify the level of bacterial colonization on the surface of the mini-screws.
Unit of Measure: Colony Forming Units per milliliter (CFU/mL), or Optical Density (OD) values at a specific wavelength (typically 600 nm), depending on the ELISA protocol used.
Assessment Method: The antimicrobial effect of the Strontium-incorporated Hydroxyapatite coating will be evaluated by comparing the level of bacterial adhesion on coated versus uncoated mini-screw surfaces.
Measured: Four mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start14 May 2025
- Primary completion14 Aug 2026
- Study completion14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Inflammation and Loss the Orthodontic Mini-screwsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105969
- Sponsor's protocol ID
- MS.25.04.20
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participants available upon request
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Stability the Antibacterial Efficacy and of Strontium Incorporated Hydroxyapatite [Sr-HA] Coated Mini-screws Used for Maxillary Canine Retraction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07105969
- Acronym / sponsor ID
- MS.25.04.20
- Keywords
- ▪️Sr-HA ▪️Mini-screw stability ▪️Antibacterial afficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Oct 2026 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- All patients will be treatment with fixed appliance and Roth type brackets where leveling and alignment will be done utilizing nickel titanium.
- Extraction the upper first premolars and retraction the canine will be done using 17 ×25 SS wire.
- 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.
- Symmetrical orthodontic miniscrews will be inserted between the second premolar and first molar.
- 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].
- The orthodontic main screws were loaded with a 150 g NiTi coil spring.
- On one side, a coated will be inserted, and on the other side, an uncoated will be used for the same patient.
- Coated materials will utilize [Strontium incorporated hydroxyapatite] applied by electrochemical deposition and concentration percentage about 5 % .
- No mucoperiosteal flap will be raised, and no pilot hole will be made during the procedure.
- Will be assessed throughout follow-up periods of up to four months.
Outcome Measurement:
- Assessment Orthodontic mini-screws stability (coated and uncoated) using Periotest device .
- Evaluate antimicrobial effect of Strontium incorporated Hydroxyapatite using Enzem- Linked Immunosorbent technique .
- Evaluate blood flow by periodental probe.
- Gingival health by visual assessment .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : uncoated OMSs. | No intervention | –Mini- screw uncoated by Sr-HA |
| Group 2: coated OMSs by Sr-HA | Experimental | Other: Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum companyMini-screw coated by Sr-HA |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adult patients within an age range (16-20) years.
- Orthodontic treatment plan requiring the extraction of the upper first premolars.
- Patients have fully permanent teeth are erupted (third molars are not included).
- No previous orthodontic treatment
- No medical problem that could interfere with treatment.
Key exclusion criteria (3 listed)
- Presence of problematic healing such as, compromised immune defense, bleeding disorder, pathological bone quality, and xerostomia.
- Inadequate oral hygiene.
- Heavy smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum companyAlso: Mini -screw stabilityMaxillary canine retraction by mini-screw loaded with 150g Niti coil spring | Other | Group 2: coated OMSs by Sr-HA |
Primary outcome
Orthodontic mini-screws stability
Time frame: Four mounth
Mean value of orthodontic mini-screw stability assessed using the Periotest device Measurement Tool: A Periotest device (manufactured by Medizintechnik Gulden, Germany) will be used to evaluate the mechanical stability of the orthodontic mini-screws. Unit of Measure: Periotest Values (PTV), expressed as numerical values ranging from -8 (high stability) to +50 (low stability). Assessment Method: The stability of both coated (Strontium-incorporated Hydroxyapatite) and uncoated orthodontic mini-screws will be measured and compared at specific time intervals throughout the study period.
1 secondary outcome
Anti microbial effect
Time frame: Four mounth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. individual participants available upon request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strontium Incorporated Hydroxyapatite [Sr-HA] coated mini-screws purchased from Dentarum company in people with Gingival Inflammation and Loss the Orthodontic Mini-screws, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthodontic mini-screws stability (time frame: Four mounth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.