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Laser in Dentisry

Title : Evaluation of the effect of photodynamic therapy on coated orthodontic mini-screws with zinc oxide nanoparticles stability, peri-miniscrew gingival condition and patient pain belief: A parallel randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250811066814N1
Enrollment
60
Registered
2025-09-14
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stability of coated orthodontic mini-screws with zinc oxide nanoparticles , peri-miniscrew gingival condition and patient pain belief. -

Interventions

Intervention 1: Intervention group 1 (Photodynamic therapy): Titanium miniscrew, 1.6 mm diameter and 10 mm length (American Orthodontics, Sheboygan, WI, USA), coated with zinc oxide nanoparticles (ZnO
Pishgaman Nanomavad Iranian, Mashhad, Iran) using electrostatic spray deposition. After placement, LED irradiation at 450±5 nm and 1000–1400 mW/cm² will be applied for 1 min, repeated once more after
Pishgaman Nanomavad Iranian, Mashhad, Iran) using electrostatic spray deposition. No LED irradiation will be applied in this group. Intervention 3: Intervention group 3 (LED): Titanium miniscrew, 1.6

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 28 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 28 who are periodontally healthy. Require the use of mini-screws for orthodontic treatment. The orthodontic treatment plan for these patients (diagnosed with Class II Division I malocclusion) involves extraction of the maxillary first premolars and requires absolute anchorage.

Exclusion criteria

Exclusion criteria: Active gag reflex, smoking, presence of periodontal disease, additional forces including mechanical forces from orthodontics and traumatic occlusion, systemic diseases that interfere with tissue healing such as diabetes, treatment with high-dose steroids, radiotherapy, or immunosuppressive therapies, pregnancy, breastfeeding, gastrointestinal problems, and allergy to impression materials. Patients who do not attend regular follow-up visits after mini-screw placement. History of medication use that interferes with healing or causes gingival overgrowth.

Design outcomes

Primary

MeasureTime frame
Stability. Timepoint: Immediately after placing the mini-screw and on days 7, 14, and 30 after placement. Method of measurement: Osstell ISQ RFA device.

Secondary

MeasureTime frame
Concentration of inflammatory factors (TNF-a and IL-1ß). Timepoint: Immediately after mini-screw placement and on days 7, 14, and 30. Method of measurement: ELISA Kit.;Gingival index score. Timepoint: Immediately after placing the mini-screw and on days 7, 14, and 30 after placement. Method of measurement: Modified Gingival Index based on Löe & Silness.;Pain. Timepoint: Immediately after placing the mini-screw and on 7th after placement. Method of measurement: Visual Analogue Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRashin Bahrami

Iran University of Medical Sciences

bahramirashin@yahoo.com+98 21 6691 5656

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026