]>
IRCT20231112060032N1 IRCT 2023-12-20 Mashhad University of Medical Sciences Effect of photodynamic therapy on chronic periodontitis Evaluation of the effect of photodynamic therapy in improvement of periodontal parameters in chronic periodontitis patients 2024-02-04 anticipated 35 Complete https://irct.ir/trial/73761 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block method is used for randomization. According to the table of random numbers, if the number is even, it will be placed in block A and the next person will be placed in block B and if the number is odd, it will be placed in block B and the next number will automatically be placed in block A. In this study, the control groups are the right and left side of the participants' mouths. After the random assignment and before the treatment, a closed envelope is given to the performer so based on that, he knows which side to apply the laser on and which side to apply the laser off, Blinding description: The principal investigator who applies the laser knows whether the laser is on or off and cannot be blind. The participants are blinded by wearing glasses and setting the device in such a way that the laser will be applied and the injection of placebo substance on the control side and curcumin injection on the intervention side. The evaluator is blinded by not knowing about the treatment and control group. 3 Chronic periodontitis. Intervention 1: Intervention group: The study is designed as a split-mouth (treatment with or without photodynamic therapy is randomly performed in each half).In treatment protocol in the first visit, the quadrants are equally divided into right and left sides, one side is performed as an intervention group (SRP and photodynamic therapy).After supra and subgingival scaling and whole mouth brossage, we inject photosensitizing solution Nano-Curcumin (N-CUR) (Sina Curcumin, Exir Nano sina, Tehran, Iran) which is dissolved in distilled water and has a concentration of 5g/l into the periodontal pockets on the test side. After 1 minute, remove the excess solution with a paper cone.After placing a piece of aluminum foil with a hollow 1cm*1cm square in the middle on the tooth، irradiate and activate the remaining solution in the buccal and palatal (lingual) tooth for 60 seconds non continuously (between three intervals of 20 seconds, two intervals of 60 seconds stop) with diode light (LED), 1200MV/CM2 (Woodpecker‚ X-cure‚ Guilin‚ China) that emits blue light with a spectrum of 515-385 nm and a central wavelength of 450 nm. The second visit is 1 week later and all previous treatments are repeated. Intervention 2: Control group: The study is designed as a split-mouth (treatment with or without photodynamic therapy is randomly performed in each half).In treatment protocol in the first visit, the quadrants are equally divided into right and left sides. On one side, only SRP is performed as a control group.After supra and subgingival scaling and whole mouth brossage, In the periodontal pockets of the control side, we put a neutral solution on the gingiva as a placebo and then wash it.The device is placed on the teeth for 60 seconds in a off mode like in the intervention group.The second visit is 1 week later and all previous treatments are repeated. Yes - There is a plan to make this available What will be shared: All data will not be published and only data related to the main outcomes included plaque index, bleeding on probing, clinical probing depth and clinical attachment level will be shared. When: It is possible to access the data from one month after printing the results. To whom: Reputable scientific journals and academic institutions are allowed to request access to the data Conditions: The crude data is provided to people who apply only for statistical analysis. Where to obtain: To receive data, the corresponding author should be consulted. How to obtain: After sending the email to the corresponding author, the correctness of applicants information will be checked and after confirmation, the data will be provided. Comments:
public Shabnam Ganjehzadeh
The beginning of Vakil Abad Blvd،Azadi Square
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 ganjehzadehsh@mums.ac.ir Mashhad University of Medical Sciences scientific Farzaneh Ahrari
The beginning of Vakil Abad Blvd،Azadi Square
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 ahrarif@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Chronic periodontitis patients who have pockets with a depth of 4-7 mm in each quadrant and optimal systemic health. no limit no limit Both Patients who have less than 16 teeth or partial or fixed dentures. Patients who have teeth with grade 3 laxity. Patients who have pockets deeper than 7mm. People who have taken antibiotics in the last 6 months. People who are pregnant or breastfeeding. People who smoke. Patients who do not want to cooperate. K05.3 Chronic periodontitis Treatment - Devices Treatment - Devices Intervention group: The study is designed as a split-mouth (treatment with or without photodynamic therapy is randomly performed in each half).In treatment protocol in the first visit, the quadrants are equally divided into right and left sides, one side is performed as an intervention group (SRP and photodynamic therapy).After supra and subgingival scaling and whole mouth brossage, we inject photosensitizing solution Nano-Curcumin (N-CUR) (Sina Curcumin, Exir Nano sina, Tehran, Iran) which is dissolved in distilled water and has a concentration of 5g/l into the periodontal pockets on the test side. After 1 minute, remove the excess solution with a paper cone.After placing a piece of aluminum foil with a hollow 1cm*1cm square in the middle on the tooth، irradiate and activate the remaining solution in the buccal and palatal (lingual) tooth for 60 seconds non continuously (between three intervals of 20 seconds, two intervals of 60 seconds stop) with diode light (LED), 1200MV/CM2 (Woodpecker‚ X-cure‚ Guilin‚ China) that emits blue light with a spectrum of 515-385 nm and a central wavelength of 450 nm. The second visit is 1 week later and all previous treatments are repeated. Control group: The study is designed as a split-mouth (treatment with or without photodynamic therapy is randomly performed in each half).In treatment protocol in the first visit, the quadrants are equally divided into right and left sides. On one side, only SRP is performed as a control group.After supra and subgingival scaling and whole mouth brossage, In the periodontal pockets of the control side, we put a neutral solution on the gingiva as a placebo and then wash it.The device is placed on the teeth for 60 seconds in a off mode like in the intervention group.The second visit is 1 week later and all previous treatments are repeated. Clinical depth of probing. Timepoint: Pocket depth was measured at the beginning of the study, 1, 3 and 6 months after treatment. Method of measurement: Clinical measurements are performed at 6 points around the teeth using William's standard periodontal probe. Clinical attachment level. Timepoint: Pocket depth was measured at the beginning of the study, 1, 3 and 6 months after treatment. Method of measurement: Clinical measurements are performed at 6 points around the teeth using William's standard periodontal probe. Bleeding on probing. Timepoint: Pocket depth was measured at the beginning of the study, 1, 3 and 6 months after treatment. Method of measurement: Clinical measurements are performed at 6 points around the teeth using William's standard periodontal probe and Animo & Bay sulcus bleeding index. Plaque Index. Timepoint: Pocket depth was measured at the beginning of the study, 1, 3 and 6 months after treatment. Method of measurement: Clinical measurements are performed at 6 points around the teeth using William's standard periodontal probe and Silness & Loe Plaque index. Mashhad University of Medical Sciences Approved 2023-11-07 Ethics committee of Mashhad University of Medical Sciences The beginning of Vakil Abad Blvd، Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)