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IRCT20230719058851N1 IRCT 2023-07-27 Ilam University of Medical Sciences Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molars with reversible pulpitis in 3-6 years old children: a randomized clinical trial Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molars with reversible pulpitis in 3-6 years old children: a randomized clinical trial 2023-08-06 anticipated 50 Complete https://irct.ir/trial/71469 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple method using a table of random numbers will be used to randomly select people; In this way, first, the order "AB" is considered for the odd number, and the order "BA" is considered for the even number. Then we refer to the table, choose a column randomly and if the first selected number is odd, we use the order 'AB'; In this way, the first person in group A will receive Mineral Trioxide Aggregate treatment and the next person will receive cold ceramic treatment spontaneously in group B. In the same way, if the number obtained is even, consider the order of BA and the first person will be placed in group B and receive cold ceramic treatment, and the next person will automatically be placed in group A and receive Mineral Trioxide Aggregate treatment. This work is repeated for 25 times to get 25 samples in each group, Blinding description: Clinical and radiographic evaluations are performed by a person who does not know the type of substance used in each group. - The patient will not know the type of material used in each tooth. 2-3 Mandibular molars reversible pulpitis. Intervention 1: Intervention group A:First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne xcp (dentsply, USA). Film number zero is used with speed E (Kodak, Ekta speed) or speed F (Kodak, Insigne). Then appropriate local anesthesia is performed using lidocaine 2% and epinephrine 1:80000 (Darou pakhsh, Tehran, Iran) and then the surface of the tooth is primed with chlorhexidine 0.2% (Shahre Daru, Tehran, Iran) and the coronal caries are removed by providing isolation with rubberdam under sterile conditions and with an Angle No. 4 burr.In the next step, the roof of the pulp chamber is removed with a 330 high speed bur along with water spray and the coronal access hole is completed. Using a large process bur (No. 6), the coronal pulp is completely removed from the entrance of the canals and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the site of coronal pulp excision, on the entrance of the canals, using a sterile cotton ball moistened with normal saline within 5 minutes (2,3,5). If homeostasis is not achieved, the patient is excluded from the study. The remaining pulp is covered with two millimeters of paste (cerkamed Medical Company Poland) MTA+. which will be obtained by mixing the powder with sterile saline at a ratio of 3:1 and is covered. A layer of zonalin (Golchadent company) is temporarily placed and the patient is visited again seven days later (short term follow up). Before placing the Stainless Steel Crown (SSC), the operator first checks the clinical signs, pain, sensitivity to impact, swelling, laxity and fistula. In the absence of the mentioned cases, the tooth will be repaired with SSC. The patient will not know the type of material used in each tooth. Intervention 2: Intervention group B : Intervention group A:First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne xcp (dentsply, USA). Film number zero is used with speed E (Kodak, Ekta speed) or speed F (Kodak, Insigne). Then appropriate local anesthesia is performed using lidocaine 2% and epinephrine 1:80000 (Darou pakhsh, Tehran, Iran) and then the surface of the tooth is primed with chlorhexidine 0.2% (Shahre Daru, Tehran, Iran) and the coronal caries are removed by providing isolation with rubberdam under sterile conditions and with an Angle No. 4 burr.In the next step, the roof of the pulp chamber is removed with a 330 high speed bur along with water spray and the coronal access hole is completed. Using a large process bur (No. 6), the coronal pulp is completely removed from the entrance of the canals and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the site of coronal pulp excision, on the entrance of the canals, using a sterile cotton ball moistened with normal saline within 5 minutes (2,3,5). If homeostasis is not achieved, the patient is excluded from the study. The remaining pulp is covered with three millimeters of paste cold ceramic is covered. A layer of zonalin (Golchadent company) is temporarily placed and the patient is visited again seven days later (short term follow up). Before placing the Stainless Steel Crown (SSC), the operator first checks the clinical signs, pain, sensitivity to impact, swelling, laxity and fistula. In the absence of the mentioned cases, the tooth will be repaired with SSC. The patient will not know the type of material used in each tooth. Yes - There is a plan to make this available What will be shared: All data will be shareable When: Access period 6 months after publication of results To whom: Researchers working in academic and scientific institutions Conditions: No other conditions are required Where to obtain: Contact via mail : faezeazizi96@gmail.com How to obtain: As soon as the request is received, the documents will be provided to the requester within a week Comments:
public Shirin Marzughi
Pajoohesh blvd
ilam Iran (Islamic Republic of) 6967114459 +98 84 3222 7134 shirin.marzoughi@gmail.com Ilam University of Medical Sciences scientific Shirin Marzughi
Pajoohesh blvd
ilam Iran (Islamic Republic of) 6967114459 +98 84 3222 7134 shirin.marzoughi@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) The presence of two-thirds of the root length in terms of radiography; and lack of radiographic evidence of pulp degeneration, such as internal or external root resorption, furca radiolucency, intraradicular or periapical bone destruction, pulp stones. Includes patients who have no systemic diseases such as congenital or rheumatic heart disease, leukemia, allergic reactions to substances such as local anesthetics and latex. They have good individual and family cooperation, deep pitted lesions whose pulp is exposed during caries removal. 3 years 6 years Both The presence of any clinical and radiographic symptoms indicating pulpal degeneration or physiological analysis of more than 2/3 of the root (imminence of tooth loss) non-physiological analysis of the root or possibility of proper tooth restoration. K04.0 Pulpitis Treatment - Other Treatment - Other Intervention group A:First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne xcp (dentsply, USA). Film number zero is used with speed E (Kodak, Ekta speed) or speed F (Kodak, Insigne). Then appropriate local anesthesia is performed using lidocaine 2% and epinephrine 1:80000 (Darou pakhsh, Tehran, Iran) and then the surface of the tooth is primed with chlorhexidine 0.2% (Shahre Daru, Tehran, Iran) and the coronal caries are removed by providing isolation with rubberdam under sterile conditions and with an Angle No. 4 burr.In the next step, the roof of the pulp chamber is removed with a 330 high speed bur along with water spray and the coronal access hole is completed. Using a large process bur (No. 6), the coronal pulp is completely removed from the entrance of the canals and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the site of coronal pulp excision, on the entrance of the canals, using a sterile cotton ball moistened with normal saline within 5 minutes (2,3,5). If homeostasis is not achieved, the patient is excluded from the study. The remaining pulp is covered with two millimeters of paste (cerkamed Medical Company Poland) MTA+. which will be obtained by mixing the powder with sterile saline at a ratio of 3:1 and is covered. A layer of zonalin (Golchadent company) is temporarily placed and the patient is visited again seven days later (short term follow up). Before placing the Stainless Steel Crown (SSC), the operator first checks the clinical signs, pain, sensitivity to impact, swelling, laxity and fistula. In the absence of the mentioned cases, the tooth will be repaired with SSC. The patient will not know the type of material used in each tooth. Intervention group B : Intervention group A:First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne xcp (dentsply, USA). Film number zero is used with speed E (Kodak, Ekta speed) or speed F (Kodak, Insigne). Then appropriate local anesthesia is performed using lidocaine 2% and epinephrine 1:80000 (Darou pakhsh, Tehran, Iran) and then the surface of the tooth is primed with chlorhexidine 0.2% (Shahre Daru, Tehran, Iran) and the coronal caries are removed by providing isolation with rubberdam under sterile conditions and with an Angle No. 4 burr.In the next step, the roof of the pulp chamber is removed with a 330 high speed bur along with water spray and the coronal access hole is completed. Using a large process bur (No. 6), the coronal pulp is completely removed from the entrance of the canals and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the site of coronal pulp excision, on the entrance of the canals, using a sterile cotton ball moistened with normal saline within 5 minutes (2,3,5). If homeostasis is not achieved, the patient is excluded from the study. The remaining pulp is covered with three millimeters of paste cold ceramic is covered. A layer of zonalin (Golchadent company) is temporarily placed and the patient is visited again seven days later (short term follow up). Before placing the Stainless Steel Crown (SSC), the operator first checks the clinical signs, pain, sensitivity to impact, swelling, laxity and fistula. In the absence of the mentioned cases, the tooth will be repaired with SSC. The patient will not know the type of material used in each tooth. Frequency of pain in treated molars. Timepoint: 3,6 and 12 months after treatment. Method of measurement: The history of the presence or absence of spontaneous pain after the treatment is asked from the patient. (Yes/No). The frequency of occurrence of sensitivity to dex in treated primary molars. Timepoint: 3,6 and 12 months after treatment. Method of measurement: During a clinical examination with a precision test, the patient is asked if there is any sensitivity or not. The frequency of occurrence swelling in treated primary molars. Timepoint: 3,6 and 12 months after treatment. Method of measurement: A clinical examination is performed to detect the presence or absence of swelling. The frequency of occurrence fistula in treated primary molars. Timepoint: 3,6 and 12 months after treatment. Method of measurement: A clinical examination is performed to detect the presence or absence of fistula. The frequency of occurrence pathologic mobility in treated primary molars. Timepoint: 3,6 and 12 months after treatment. Method of measurement: A clinical examination is performed to detect the presence or absence of pathologic mobility. The frequency of occurrence of root lucency in radiographic images in treated primary molars. Timepoint: 6 and 12 month after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of lucency around the root. The frequency of occurrence of internal resorbtion in radiographic images in treated primary molars. Timepoint: 6 and 12 month after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of internal resorbtion. The frequency of occurrence of external resorbtion in radiographic images in treated primary molars. Timepoint: 6 and 12 month after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of external resorbtion. The frequency of occurrence of PDL widening in radiographic images in treated primary molars. Timepoint: 6 and 12 month after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of PDL widening. The frequency of occurrence of bone resorbtion in radiographic images in treated primary molars. Timepoint: 6 and 12 month after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of bone resorbtion. The frequency of occurrence of lamina dura disintegration in radiographic images in treated primary molars. Timepoint: 6 and 12 month after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of lamina dura disintegration. Ilam University of Medical Sciences Approved 2023-07-17 Ethics committee of Islam university of medical science Pajoohesh blvd Ilam Ilam Iran (Islamic Republic of)