]>
IRCT20100125003168N6 IRCT 2018-11-02 Reasearch Vice-Chancellor- Tabriz University of Medical Sciences Comparison of effect of Protooth and Mineral Trioxide Aggregate in Direct pulp capping of primary molars Comparison of the effect of novel fast setting calcium silicate cement containing fluoride (Protooth) and Mineral Trioxide Aggregate in direct pulp capping of primary molars; A split mouth randomized controlled clinical trial 2018-10-01 anticipated 45 Complete https://irct.ir/trial/34337 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by throwing a coin. One side of coin is assigned to the MTA and the other side is assigned to Protooth, and the first throw, determines the material used on the right primary molar of the patient, Blinding description: In this study, participants are unaware of the allocation of study groups and information is not given to the parents about which of the materials is used in the patient's left or right primary molar. N/A Dental caries. Intervention 1: Intervention group:The effect of Protooth (Ultrafast Protooth, Dentosolve, Aarhus, Denmark) in direct pulp capping of primary molars. This material was applied by using its own commercial instrument with a rounded tip in a layer with maximum thickness of 1.5 millimeters and then covered with a low viscosity Glass Ionomer layer (RMGI, Fuji II, LC GC, America) with a thickness of 2 mm to ensure the proper seal. Intervention 2: Control group: The effect of MTA (ProRoot; Dentsply, Tulsa, OK, USA) in direct pulp capping of primary molars. This material will be handled and applied to the exposure site with an MTA carrier, gently pressed with a moist cotton pellet for better adaptation with the exposure site, and then covered with a low viscosity Glass Ionomer layer (RMGI, Fuji II, LC GC, America) with a thickness of 2 mm to ensure the proper seal. Yes - There is a plan to make this available What will be shared: The whole data is shareable. When: Access granted 6 months after publication of results To whom: Physicians and researchers in medical sciences as well as those involved in industry Conditions: Data are released for non commercial purposes and for research objectives only. Where to obtain: Dr.Niloofar Azima Pediatric dentistry department, Tabriz dental faculty, Tabriz University of medical sciences, Golgasht street. niloofar_azima@yahoo.com 04133346977 How to obtain: The applicant should forward their application to the email provided. the data will be send via email at 72 hours at most. Comments:
public Dr Ali Vafaie
Pediatric Dentistry department,Dentistry faculty, Tabriz University of Medical Sciences , Golgasht street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 413355965 alivafaiitbzmed@gmail.com Tabriz University of Medical Sciences scientific Dr Leila Erfanparast
Pediatric Dentistry department, Dentistry faculty, Tabriz University of Medical Sciences, Golgasht street, tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 413355965 leilaerfan@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 5-8 years old children Having a pair of symmetric second primary molar teeth in one jaw having deep caries and vital pulp Capable of being restored by amalgam filling No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test Complete physical and mental health with no confounding history of systemic disease and/or use of special local or systemic drugs; No allergic reactions recorded in patient history No sign of radiolucency in periapical or furcation area No widening of PDL space or loss of lamina dura continuity No evidence of internal/external pathologic root resorption 5 years 8 years Both Lack of informed consent by the child patient’s parent Abnormal bleeding at the site of pulp exposure (i.e. bleeding which lasts for more than 3 minutes) No evidence of pulp exposure at the site of caries excavation in symmetric second primary molar teeth, which were conventionally restored with an amalgam filling and excluded from our study Evidence of pulp exposure surrounded by carious dentin which is indicative of pulpal contamination K02 Dental caries Treatment - Other Treatment - Other Intervention group:The effect of Protooth (Ultrafast Protooth, Dentosolve, Aarhus, Denmark) in direct pulp capping of primary molars. This material was applied by using its own commercial instrument with a rounded tip in a layer with maximum thickness of 1.5 millimeters and then covered with a low viscosity Glass Ionomer layer (RMGI, Fuji II, LC GC, America) with a thickness of 2 mm to ensure the proper seal. Control group: The effect of MTA (ProRoot; Dentsply, Tulsa, OK, USA) in direct pulp capping of primary molars. This material will be handled and applied to the exposure site with an MTA carrier, gently pressed with a moist cotton pellet for better adaptation with the exposure site, and then covered with a low viscosity Glass Ionomer layer (RMGI, Fuji II, LC GC, America) with a thickness of 2 mm to ensure the proper seal. Dental pulp vitality after treatment. Timepoint: 6 &12 months. Method of measurement: Lack of any of clinical or radiographic signs or symptoms of treatment failure. Radiographic success. Timepoint: 6&12 months. Method of measurement: Presence of one or more of the following radiographic signs will be considered as failure of treatment: internal and/or external root resorption, periodontal space widening, inter-radicular radiolucency, and periapical lesions. Clinical success. Timepoint: 6 &12 months. Method of measurement: Presence of one or more of the following clinical signs/symptoms will be considered as failure of treatment: spontaneous pain, swelling, pathologic mobility, tenderness to pressure, and presence of sinus tract, swelling, and sensitivity to percussion. Reasearch Vice-Chancellor- Tabriz University of Medical Sciences Approved 2018-10-22 Ethics Commitee of Research Department - Tabriz University of Medical Sciences Research Department- Tabriz University of Medical Sciences- Golgasht street- Tabriz- Iran Tabriz East Azarbaijan Iran (Islamic Republic of)