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IRCT20250811066814N1 IRCT 2025-09-14 Iran University of Medical Sciences 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 2025-10-23 anticipated 60 Complete https://irct.ir/trial/85453 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with a block size of 6 and an individual unit of randomization is used. In each block, all interventions are repeated once. The allocation sequence is generated using a six-sided dice by the study epidemiologist. Randomization is non-stratified. For allocation concealment, the final sequence is placed in opaque, sealed, and numbered envelopes, which are opened only at the time of each participant’s enrollment. Only the study epidemiologist is aware of the allocation sequence and is not involved in intervention delivery or data collection, Blinding description: Only the operator is aware of the allocation. Participants, sample collectors, outcome assessors, and the statistician are blinded to group assignment. All miniscrews (American Orthodontics, USA) are identical in size, shape, and color, and differences related to ZnO coating or LED irradiation are not distinguishable to participants. Therefore, participant-level blinding is feasible. To prevent unblinding during analysis, statistical codes are designed independently from envelope numbers. 3 stability of coated orthodontic mini-screws with zinc oxide nanoparticles , peri-miniscrew gingival condition and patient pain belief. 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 force loading. Intervention 2: Intervention group 2 (ZnO): 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. No LED irradiation will be applied in this group. Intervention 3: Intervention group 3 (LED): Titanium miniscrew, 1.6 mm diameter and 10 mm length (American Orthodontics, Sheboygan, WI, USA), uncoated. After placement, LED irradiation at 450±5 nm and 1000–1400 mW/cm² will be applied for 1 min, repeated once more after force loading. Intervention 4: Intervention group 4 (Positive control): Titanium miniscrew, 1.6 mm diameter and 10 mm length (American Orthodontics, Sheboygan, WI, USA), uncoated and non-irradiated. Patients will use 0.2% chlorhexidine mouthwash (Nazhou, Iran), twice daily for 30 seconds according to manufacturer’s instructions. Intervention 5: Intervention group 5 (Negative control): Titanium miniscrew, 1.6 mm diameter and 10 mm length (American Orthodontics, Sheboygan, WI, USA), uncoated and non-irradiated, without any adjunctive treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Rashin Bahrami
Azadi Street - South Jamalzadeh _ Corner of Jamshid Alley _ No. 168
Tehran Iran (Islamic Republic of) 1313883851 +98 21 6691 5656 bahramirashin@yahoo.com Iran University of Medical Sciences scientific Rashin Bahrami
Azadi Street - South Jamalzadeh _ Corner of Jamshid Alley _ No. 168
Tehran Iran (Islamic Republic of) 1313883851 +98 21 6691 5656 bahramirashin@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 28 years Both 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. - - Treatment - Other Treatment - Other Treatment - Other Treatment - Other Other 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 force loading. Intervention group 2 (ZnO): 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. No LED irradiation will be applied in this group. Intervention group 3 (LED): Titanium miniscrew, 1.6 mm diameter and 10 mm length (American Orthodontics, Sheboygan, WI, USA), uncoated. After placement, LED irradiation at 450±5 nm and 1000–1400 mW/cm² will be applied for 1 min, repeated once more after force loading. Intervention group 4 (Positive control): Titanium miniscrew, 1.6 mm diameter and 10 mm length (American Orthodontics, Sheboygan, WI, USA), uncoated and non-irradiated. Patients will use 0.2% chlorhexidine mouthwash (Nazhou, Iran), twice daily for 30 seconds according to manufacturer’s instructions. Intervention group 5 (Negative control): Titanium miniscrew, 1.6 mm diameter and 10 mm length (American Orthodontics, Sheboygan, WI, USA), uncoated and non-irradiated, without any adjunctive treatment. Stability. Timepoint: Immediately after placing the mini-screw and on days 7, 14, and 30 after placement. Method of measurement: Osstell ISQ RFA device. Concentration of inflammatory factors (TNF-α and IL-1β). 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. Iran University of Medical Sciences Approved 2025-07-21 Research Ethics Committees of Iran University of Medical Sciences Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)