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IRCT20230223057507N1 IRCT 2023-06-04 Tehran University of Medical Sciences Investigating the effect of photodynamic therapy in reducing caries in removable orthodontics Evaluation of antimicrobial photodynamic therapy effects of orthodontic resin acrylic containing Curcumin-nisin poly-lactic acid nanoparticles (CurNisNp): A randomized, double-blind case-control clinical trial 2023-04-04 anticipated 12 Complete https://irct.ir/trial/68919 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization, Randomization unit: individual, Randomization tool: sealed envelope,, Blinding description: Number and coding for groups and patients in such a way that the microbiologist and orthodontist are not aware of the assigned code for groups and individuals. N/A orthodontics. Intervention 1: The device used in the intervention group is a removable appliance made of acrylic methacrylate (Sigma-Aldrich) containing 5% curcumin-nisin poly-lactic acid nanoparticles. The curcumin, nisin, and lactic acid nanoparticles are obtained from Merck and Sigma-Aldrich, Germany. After making a mold of the patient's mouth and creating the removable appliance with the nanoparticles, the appliance is immediately placed in the patient's mouth, and the mouth is exposed to LED radiation (wavelength 450 nm, 5 minutes) for photodynamic therapy. Saliva is collected from the patient after the treatment. The removable appliance remains in the patient's mouth for 6 months, and at monthly visits before and after LED irradiation, unstimulated saliva preparation is conducted to determine the population of S. mutans. Intervention 2: In the comparison group, a removable appliance was used as the device. The appliance was manufactured using only acrylic methacrylate (made by Sigma-Aldrich, Germany). After making a mold of the patient's mouth, the removable appliance was placed in the patient's mouth, and saliva was obtained. The removable appliance remained in the patient's mouth for 6 months, and at monthly visits, saliva preparation was conducted to determine the population of S. mutans. No - There is not a plan to make this available Justification or reason for not sharing IPD is Non-identifiable personal data of participants is not important for publication.
public Abbas Bahador
Enghelab Ave.,
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5810 ab.bahador@gmail.com Tehran University of Medical Sciences scientific Abbas Bahador
Poursina
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5810 abahador@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Has at least 20 permanent teeth Treatment plan with movable orthodontic appliance (acrylic). 7 years 15 years Both Extensive tooth fillings Removable denture Underlying diseases Periodontal diseases Tooth loss due to extensive caries Use of antibiotics in less than 1 month Lack of Streptococcus mutans in the screening phase (Base line) Treatment - Devices Treatment - Devices The device used in the intervention group is a removable appliance made of acrylic methacrylate (Sigma-Aldrich) containing 5% curcumin-nisin poly-lactic acid nanoparticles. The curcumin, nisin, and lactic acid nanoparticles are obtained from Merck and Sigma-Aldrich, Germany. After making a mold of the patient's mouth and creating the removable appliance with the nanoparticles, the appliance is immediately placed in the patient's mouth, and the mouth is exposed to LED radiation (wavelength 450 nm, 5 minutes) for photodynamic therapy. Saliva is collected from the patient after the treatment. The removable appliance remains in the patient's mouth for 6 months, and at monthly visits before and after LED irradiation, unstimulated saliva preparation is conducted to determine the population of S. mutans. In the comparison group, a removable appliance was used as the device. The appliance was manufactured using only acrylic methacrylate (made by Sigma-Aldrich, Germany). After making a mold of the patient's mouth, the removable appliance was placed in the patient's mouth, and saliva was obtained. The removable appliance remained in the patient's mouth for 6 months, and at monthly visits, saliva preparation was conducted to determine the population of S. mutans. Changing the population of effective bacteria in dental caries. Timepoint: Measuring the population of Streptococcus mutans at the beginning of the study (before the start of the intervention) and 30, 60, 90, 120, 150 and 180 days after using the removable acrylic resin appliance. Method of measurement: Counting of bacterial population via serial dilution. Tehran University of Medical Sciences Approved 2023-02-12 Ethics committee ofTehran University of Medical Sciences Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)