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IRCT20210419051016N1 IRCT 2021-08-09 Esfahan University of Medical Sciences Evaluation of success & failure of Mineral Trioxide Aggregate (MTA) & Biodentine in pulp therapy of second mandibular primary molar with irreversible pulpitis Comparative evaluation of clinical & radiographic success & failure rate of Mineral Trioxide Aggregate (MTA) & Biodentine in pulp therapy of second mandibular primary molar with irreversible pulpitis in 3-6 years old children 2021-07-11 anticipated 50 Complete https://irct.ir/trial/57286 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, simple allocation will be the method of choice for random allocation of the patients. In this method, the 'AB' order is considered for each odd number, and the 'BA' order is considered for each even number. Then a column is randomly selected from the table and if the first selected number is odd, the 'AB' order is applied which means the first patient is allocated in the A group and receives MTA treatment, and as a result, the next patient is allocated to the B group and receives Biodentine treatment. Similarly, If the selected number is even, the 'BA' order is applied and the first patient is allocated in the B group and receives Biodentine treatment, and as a result, the next patient is allocated to the A group and receives MTA treatment. This is done 25 times until 25 samples are reached in each group, Blinding description: -Outcome assessor was not aware of the type of material used for each tooth while evaluating the treated teeth clinically and radiographically -Patients were not aware of the type of material used for their treatment. 2-3 Irreversible pulpitis of second mandibular primary molar. Intervention 1: Intervention group A: Firstly, periapical radiographic imaging with paralleling technique is provided using Rinne XCP ( DENTSPLY, USA) film holder and size 0 film with either E speed (Kodak, Ekta speed) or F speed (Kodak, insigne). Then proper local anesthesia injection is done using Lidocaine 2% and Epinephrine 1:80000 (Darou pakhsh, Tehran, Iran), and preparation of the tooth surface is done with 0.2% chlorhexidine (Shahre Daru, Tehran, Iran) is provided. after isolation with a rubber dam, coronal caries is removed using a sterile carbide round no.4 bur. Then, a high-speed 330 bur is used for removing the roof of the pulp chamber and access cavity preparation is completed. Afterward, by using a large round bur (no.6) coronal pulp tissue is removed completely from the canal orifices and the pulp chamber is then rinsed using sterile normal saline. Hemostasis is provided by applying saline-impregnated sterile cotton for 5 minutes. If bleeding is not controlled, the patient will be excluded from the study. To seal the canals and prevent bacterial invasion, the remaining pulp is covered with 2mm of MTA+ paste (CERKAMED Medical Company Poland) which is prepared by mixing the powder with sterile saline with 3:1 proportions. A layer of zonaline (Golchadent company) is placed as a provisional restoration. The patient will be recalled 7 days after treatment and if there would not be any sign or symptoms of treatment failure including pain, sensitivity to concussion, swelling, mobility, and fistula Stainless Steel Crown will provide the final restoration for the given tooth. Intervention 2: Intervention group B: Firstly, periapical radiographic imaging with paralleling technique is provided using Rinne XCP ( DENTSPLY, USA) film holder and size 0 film with either E speed (Kodak, Ekta speed) or F speed (Kodak, insigne). Then proper local anesthesia injection is done using Lidocaine 2% and Epinephrine 1:80000 (Darou pakhsh, Tehran, Iran), and preparation of the tooth surface is done with 0.2% chlorhexidine (Shahre Daru, Tehran, Iran) is provided. after isolation with a rubber dam, coronal caries is removed using a sterile carbide round no.4 bur. Then, a high-speed 330 bur is used for removing the roof of the pulp chamber and access cavity preparation is completed. Afterward, by using a large round bur (no.6) coronal pulp tissue is removed completely from the canal orifices and the pulp chamber is then rinsed using sterile normal saline. Hemostasis is provided by applying saline-impregnated sterile cotton for 5 minutes. If bleeding is not controlled, the patient will be excluded from the study. To seal the canals and prevent bacterial invasion, the remaining pulp is covered with 3 mm of Biodentine (Septodont, Saint-Maur-des-Fosses Cedex, France). A layer of zonaline (Golchadent company) is placed as a provisional restoration. The patient will be recalled 7 days after treatment and if there would not be any sign or symptoms of treatment failure including pain, sensitivity to concussion, swelling, mobility, and fistula Stainless Steel Crown will provide the final restoration for the given tooth. Yes - There is a plan to make this available What will be shared: All data will be available When: Starting 6 months after publication To whom: Available for people working in academic institutions Conditions: No other conditions Where to obtain: Please send the request to "mona.esmaili.p@gmail.com" How to obtain: Documents will be sent in 1 week after receiving the request Comments: No more information
public Dr. Maryam Hajiahmadi
Pediatric Dentistry department, Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar-jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5539 dr.maryamhajiahmadi@gmail.com Esfahan University of Medical Sciences scientific Dr. Mona Esmaili
Pediatric Dentistry department, Dentistry Faculty, Isfahan University of Medical Sciences, Hezar-jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5539 mona.esmaili.p@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) No underlying systematic diseases which leads to inhibition of local anesthesia injection Having a vital second mandibular primary molar tooth with deep caries lesion in the crown that is not extended subgingivally more than 1 mm Having the history of typical pain related to the irreversible pulpitis (patient's chief complaint is spontaneous pain that lasts more than multiple seconds) Sensitivity to thermal stimuli All teeth are vital and the operator evaluates the pulp vitality by visual observation of pulp hemorrhage from all root canals of the intended tooth Having access to the participant for 12-months follow-up Pulp exposure due to severe carious crown No pathologic mobility No abscess, fistula, or swelling related to the intended tooth Possibility of restoration with Stainless Steel Crown (SSC) Possibility of providing hemostasis in the orifice entrance No internal or pathologic external root resorption No periapical radiolucency No widening in the periodontal ligament No radiolucency in furcation area No calcific degeneration of the pulp No root resorption more than 1/3 of the root length 3 years 6 years Both Patients with underlying systemic disorders, physical, or mental disabilities Presence of any clinical or radiographic sign of pulpal degeneration including severe hemorrhage from root canals that making hemostasis impossible in 5 minutes, internal root resorption, bone resorption in furcation or preapical area, swelling or sinus tract formation, and pulp necrosis Physiologic root resorption more than 2/3 of the root length (the sign of exfoliation) Non-physiologic root resorption Non-restorable tooth K04.0 Pulpitis Treatment - Other Treatment - Other Intervention group A: Firstly, periapical radiographic imaging with paralleling technique is provided using Rinne XCP ( DENTSPLY, USA) film holder and size 0 film with either E speed (Kodak, Ekta speed) or F speed (Kodak, insigne). Then proper local anesthesia injection is done using Lidocaine 2% and Epinephrine 1:80000 (Darou pakhsh, Tehran, Iran), and preparation of the tooth surface is done with 0.2% chlorhexidine (Shahre Daru, Tehran, Iran) is provided. after isolation with a rubber dam, coronal caries is removed using a sterile carbide round no.4 bur. Then, a high-speed 330 bur is used for removing the roof of the pulp chamber and access cavity preparation is completed. Afterward, by using a large round bur (no.6) coronal pulp tissue is removed completely from the canal orifices and the pulp chamber is then rinsed using sterile normal saline. Hemostasis is provided by applying saline-impregnated sterile cotton for 5 minutes. If bleeding is not controlled, the patient will be excluded from the study. To seal the canals and prevent bacterial invasion, the remaining pulp is covered with 2mm of MTA+ paste (CERKAMED Medical Company Poland) which is prepared by mixing the powder with sterile saline with 3:1 proportions. A layer of zonaline (Golchadent company) is placed as a provisional restoration. The patient will be recalled 7 days after treatment and if there would not be any sign or symptoms of treatment failure including pain, sensitivity to concussion, swelling, mobility, and fistula Stainless Steel Crown will provide the final restoration for the given tooth. Intervention group B: Firstly, periapical radiographic imaging with paralleling technique is provided using Rinne XCP ( DENTSPLY, USA) film holder and size 0 film with either E speed (Kodak, Ekta speed) or F speed (Kodak, insigne). Then proper local anesthesia injection is done using Lidocaine 2% and Epinephrine 1:80000 (Darou pakhsh, Tehran, Iran), and preparation of the tooth surface is done with 0.2% chlorhexidine (Shahre Daru, Tehran, Iran) is provided. after isolation with a rubber dam, coronal caries is removed using a sterile carbide round no.4 bur. Then, a high-speed 330 bur is used for removing the roof of the pulp chamber and access cavity preparation is completed. Afterward, by using a large round bur (no.6) coronal pulp tissue is removed completely from the canal orifices and the pulp chamber is then rinsed using sterile normal saline. Hemostasis is provided by applying saline-impregnated sterile cotton for 5 minutes. If bleeding is not controlled, the patient will be excluded from the study. To seal the canals and prevent bacterial invasion, the remaining pulp is covered with 3 mm of Biodentine (Septodont, Saint-Maur-des-Fosses Cedex, France). A layer of zonaline (Golchadent company) is placed as a provisional restoration. The patient will be recalled 7 days after treatment and if there would not be any sign or symptoms of treatment failure including pain, sensitivity to concussion, swelling, mobility, and fistula Stainless Steel Crown will provide the final restoration for the given tooth. Frequency of incidence of pain in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment. Method of measurement: Patient is asked about a history of spontaneous pain after treatment (yes/no question). Frequency of incidence of sensitivity to concussion in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment سه، شش و 12 ماه پس از درمان. Method of measurement: Patient is asked about the presence of sensitivity while doing concussion test (yes/no question). Frequency of incidence of swelling in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment. Method of measurement: Patient is evaluated clinically for the presence of swelling (yes/no). Frequency of incidence of fistula formation in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment. Method of measurement: Patient is evaluated clinically for the presence of fistula (yes/no). Frequency of incidence of pathologic mobility in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment. Method of measurement: Patient is evaluated clinically for the presence of pathologic mobility (yes/no). Frequency of incidence of lucency around the root in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence of lucency around the root (yes/no). Frequency of incidence of internal root resorption in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence of internal root resorption. Frequency of incidence of external root resorption in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence of external root resorption. Frequency of incidence of widening of the Periodontal Ligament (PDL) in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence of widened PDL. Frequency of incidence of bone loss in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence of bone loss. Frequency of incidence of loss of lamina dura in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence of loss of lamina dura. Esfahan University of Medical Sciences Approved 2021-05-26 Ethics committee of Isfahan University of Medical Sciences Pediatric Dentistry department, Dentistry Faculty, Isfahan University of Medical Sciences, Hezar-jerib St. Isfahan Isfehan Iran (Islamic Republic of)