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IRCT20230312057689N1 IRCT 2023-04-02 Shahed University Effect of Propolis-Nigella sativa extract on primary tooth pulp Evaluating the histopathology of primary teeth pulp after direct pulp capping by Nano-emulsion containing Propolis and Nigella-sativa: Ů‹Randomized Clinical Trial 2023-04-21 anticipated 10 Complete https://irct.ir/trial/69103 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Random allocation rule will be used. According to two main treatment agents including the propolis- nigella sativa or MTA agents, 20 cards will be prepared. On half of the cards (n=10) the A code (regarding the propolis-nigella sativa), and on other half, the B code (regarding the MTA agent) will be written. Afterwards, the cards will be kept in opaque pockets and stored in lottery container. At the beginning of the procedure, the dentist will chose one pocket and according to the code, the MTA or the propolis-nigella sativa will be used for treatment of the first tooth. Selection of the pockets will not have any replacement and the selected pocket will be discarded after recording of the agent. N/A pulpitis (pulp capping). Intervention 1: Intervention group: According to the randomization code, cavity preparation will be accomplished on one of the mandibular canine (left or right) until pulp exposure would occur. Thereafter, the propolis-nigella sativa extract (which will be produce by the present researchers) will be applied on dental pulp cells and the tooth will be restored. Two months later, based on orthodontic reason (serial extraction), the mentioned tooth will be extracted (extracting of the tooth is not related to the study process at all). Intervention 2: Control group: According to the randomization code, cavity preparation will be accomplished on one of the mandibular canine (left or right) until pulp exposure would occur. Thereafter, the MTA agent (Dentsply comany, USA) will be applied on dental pulp cells and the tooth will be restored. Two months later, based on orthodontic reason (serial extraction), the mentioned tooth will be extracted (extracting of the tooth is not related to the study process at all). Yes - There is a plan to make this available What will be shared: Pat of the data will accessible including the results regarding the histopathology evaluation would be published When: The access will be available from the Autumn of 2023 To whom: Researchers working in academic and scientific institutions Conditions: If the researchers need our available data to conduct similar research. Where to obtain: Faeze Hamze, 00983432476498, Faeze.hamze@gmail.com How to obtain: After completing the data collection, by sending an email to the provided email and explaining the reason for the need to access the data. Comments:
public Faeze Hamze
Shahed Dental School, Italia St,. Vesal Avenue
Tehran Iran (Islamic Republic of) 1417755351 +98 21 8895 9210 faeze.hamze@gmail.com Shahed University scientific Faeze Hamze
Shahed Dental School, Italia St., Vesal Avenue.
Tehran Iran (Islamic Republic of) 1417755351 +98 21 8895 9210 faeze.hamze@gmail.com Shahed University Iran (Islamic Republic of) 6-9 years old without any systemic disorder no allergy to dental anesthesia two existing mandibular canine required to be extracted due to orthodontic reason the patient and his/her parents are eager to participate in the study 6 years 9 years Both the mentioned canine teeth have root resorption more than apical third the mentioned canine have irreversible pulpitis K04.0 Pulpitis Treatment - Drugs Treatment - Drugs Intervention group: According to the randomization code, cavity preparation will be accomplished on one of the mandibular canine (left or right) until pulp exposure would occur. Thereafter, the propolis-nigella sativa extract (which will be produce by the present researchers) will be applied on dental pulp cells and the tooth will be restored. Two months later, based on orthodontic reason (serial extraction), the mentioned tooth will be extracted (extracting of the tooth is not related to the study process at all). Control group: According to the randomization code, cavity preparation will be accomplished on one of the mandibular canine (left or right) until pulp exposure would occur. Thereafter, the MTA agent (Dentsply comany, USA) will be applied on dental pulp cells and the tooth will be restored. Two months later, based on orthodontic reason (serial extraction), the mentioned tooth will be extracted (extracting of the tooth is not related to the study process at all). Percentage of dentine bridge formation. Timepoint: two months after intervention. Method of measurement: optical microscope. The intensity of the presence of inflammatory cells. Timepoint: two months after intervention. Method of measurement: optical microscope. Shahed University Approved 2023-02-27 Ethics committee of Shahed University Ethics committee, Shahed University, Opposite to Imam Khomeini Holy Shrine, Persian Gulf Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)