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IRCT20220519054917N1 IRCT 2022-06-03 Zahedan University of Medical Sciences Clinical and radiographic effects of a new calcium silicate cement in vital pulp therapy in teeth with close apex Comparison of clinical and radiographic effects of a new calcium silicate cement with Mineral trioxide Aggregate cement in vital pulp therapy as direct pulp cap in teeth with closed apex 2022-06-22 anticipated 90 Complete https://irct.ir/trial/63792 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: After the initial selection of eligible patients and its approval by the relevant resident at Zahedan Dental School, the patient will be given the necessary explanations about the implementation of the plan (how to participate, program details, schedule of the plan, types of treatment plans). If the patient wishes and approves, the patient will be provided with an adjusted consent form, which the patient will sign after the study. In this way, the patient is considered as a patient included in the plan and their treatment will be done either in the same session or in another session. 3 groups will be studied and the number of teeth to be treated; In each group, we consider 30 people and finally the total sample size is 90 people. 3 study groups including the first group: root canal treatment, the second group: direct pulp cup with MTA cement, the third group: direct pulp cup with new cement Patients are aware of the process of all three treatments and the advantages and disadvantages of all three treatments and are told that one of these three treatments is done for them randomly but patients do not know which treatment is done for them. N/A irreversible pulpitis. Intervention 1: Intervention group: Direct pulp cap with MTA cement: After confirming the complete anesthesia of the pulp with a sterile bur, first a large part of caries and weak enamel structures were removed and after complete isolation of teeth the caries near the pulp chamber was removed by new steril bur.To control bleeding, 5.25% cotton soaked in hypochlorite is used for a maximum of 10 minutes until a clean, clot-free pulp wound and bleeding are observed at the site of pulpal exposure.At this stage, MTA cement is prepared according to the factory instructions and with a thickness of 2 to 3 mm, with a gentle pressure of a dry and sterile cotton, it will be placed in the place of pulp exposure to be compatible with the walls. Excess cement is removed from the walls with a damp cotton swab, and a wet cotton swab will be in place for five minutes after making sure it is suitable (creating a white marble surface without lumps and cracks and distance from the walls). Then immediately cover it with a 2 mm of light cure glass inomer and it will be repaired with tooth-colored materials. Intervention 2: Intervention group: Intervention group: Direct pulp cap with new cement: This intervention method is exactly the same as the direct pulp coating group with MTA cement and the only difference is the use of new cement in which cement powder is synthesized by Sol-gel method and zirconium oxide is added as Appasifiers and pectin as plant-based polymers with calcium chloride as a liquid for the preparation of dental cement. Intervention 3: Control group: Root canal treatment: First, all caries and weakened enamel structures are removed and the access cavity is fully accessed. Then the preparation is done using nickel-titanium filtration file and electric motor. After drying the channels with a paper cup of the same size as the original gutta, the channel will be filled with lateral compaction technique using AH26 sealer. After filling the channels, the entrances will be covered with a 2 mm layer of resin modified glass inomer. Yes - There is a plan to make this available What will be shared: Information about the main outcome and its comparison with different groups can be shared. When: Access period starts 6 months after the results are published. To whom: Researchers working in academic and scientific institutes, dental students, dentists. Conditions: If the data are used to improve vital pulp therapy treatments and replace nationally produced biomaterials with similar foreign products in order to be self-sufficient and reduce costs and improve treatment results, all dental researchers will be able to access the data. Where to obtain: Dr.Seyed Mohammad Javad Aslani Email: Aslani.j1370@gmail.com Mobile: +989177179907 How to obtain: Please send an email to the respondent and state the resume and purpose of accessing the data for the respondent. Comments:
public Seyed Mohammad Javad Aslani
East Azadegan St. - School of Dentistry
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1814 Aslani.j1370@gmail.com Zahedan University of Medical Sciences scientific Seyed Mohammad Javad Aslani
East Azadegan St. - School of Dentistry
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1824 Aslani.j1370@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Vital molar teeth (positive response to electrical pulp tester and cold test before treatment and objective observation of pulp bleeding after preparation of access cavity) History of irreversible pulpitis (history of spontaneous or localized pain; irritation due to cold and heat that persists after stimulus removal; pain induced by cold test) or no clinical signs of irreversible pulpitis but with Pulp exposure after removal of caries Patients are in the age range of 12 to 50 years Prepared and able to attend follow-up meetings Patients have signed a consent form 12 years 50 years Both Patients with systemic diseases in which tissue repair is impaired, such as diabetes, cancer, endocrine disorders, AIDS, and those taking corticosteroids. Patients who for any reason can not inject anesthesia containing epinephrine Pregnant or lactating women. Patients with mental and physical disabilities. Patients with poor oral hygiene and periodontal disease in such a way that long-term tooth retention is not possible due to periodontal problems. People like immigrants from other countries who have a great chance of leaving the study. Age of patients less than 12 years (for the treatment of the first molar) and less than 15 years (for the treatment of the second molar) and more than 50 years. Lack of control of pulpal hemorrhage in highly inflamed teeth.(Pulp bleeding can not be controlled by placing a cotton swab dipped in 5.25% sodium hypochlorite in the chamber pulp for a maximum of ten minutes). Teeth that can not be restorated with the usual class one and two restorations with or without cusp reduction. Teeth with localized periodontal disease in a way that the survival of the tooth is not in danger, but due to exposure of the root surface, there is a possibility of pulpal stimulation and disruption of the restoration process. Teeth with external, internal resorption or visible pulp calcifications on periapical radiography Traumatized teeth Teeth with swelling of adjacent soft tissue Teeth with open apex Teeth with pericardial lesion (around the apex or forca area) visible on radiography Taking antibiotics in a recent month Taking painkillers in the last 3 days Existence of defects in restoration in follow-up sessions K04.2 Pulp degeneration Treatment - Other Treatment - Other Treatment - Other Intervention group: Direct pulp cap with MTA cement: After confirming the complete anesthesia of the pulp with a sterile bur, first a large part of caries and weak enamel structures were removed and after complete isolation of teeth the caries near the pulp chamber was removed by new steril bur.To control bleeding, 5.25% cotton soaked in hypochlorite is used for a maximum of 10 minutes until a clean, clot-free pulp wound and bleeding are observed at the site of pulpal exposure.At this stage, MTA cement is prepared according to the factory instructions and with a thickness of 2 to 3 mm, with a gentle pressure of a dry and sterile cotton, it will be placed in the place of pulp exposure to be compatible with the walls. Excess cement is removed from the walls with a damp cotton swab, and a wet cotton swab will be in place for five minutes after making sure it is suitable (creating a white marble surface without lumps and cracks and distance from the walls). Then immediately cover it with a 2 mm of light cure glass inomer and it will be repaired with tooth-colored materials. Intervention group: Intervention group: Direct pulp cap with new cement: This intervention method is exactly the same as the direct pulp coating group with MTA cement and the only difference is the use of new cement in which cement powder is synthesized by Sol-gel method and zirconium oxide is added as Appasifiers and pectin as plant-based polymers with calcium chloride as a liquid for the preparation of dental cement Control group: Root canal treatment: First, all caries and weakened enamel structures are removed and the access cavity is fully accessed. Then the preparation is done using nickel-titanium filtration file and electric motor. After drying the channels with a paper cup of the same size as the original gutta, the channel will be filled with lateral compaction technique using AH26 sealer. After filling the channels, the entrances will be covered with a 2 mm layer of resin modified glass inomer Pain. Timepoint: At intervals of 6, 12, 24 hours and then daily for a week. Method of measurement: Based on the pain recorded on the VAS pain index ruler. Clinical signs of soft tissue around the roots. Timepoint: 6 months after treatment. Method of measurement: Inflammation, redness, swelling and infection of the soft tissue adjacent to the tooth, spontaneous pain, pain on touch and knock, fistula and abscess. Symptoms of periapical radiography. Timepoint: Follow-up periods are one week and six months. Method of measurement: It is ranked based on the presence of pdl widening and radiolucency or the absence of any reaction. Existence of internal and external root resorption, apical lesion and canal calcification. The pulp condition of the treated tooth. Timepoint: Follow-up periods are one week and six months. Method of measurement: It is determined based on EPT and cold tests. Periapical conditions of the treated tooth. Timepoint: Follow-up periods are one week and six months. Method of measurement: Based on the response to the percusion and touch tests and the radiographic appearance of the desired tooth is determined. Zahedan University of Medical Sciences Approved 2022-04-17 Ethics committee of zahedan University of Medical Sciences Zahedan, East Azadegan St., School of Dentistry, Endodontics Department Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)