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IRCT201602063168N3 IRCT 2017-02-10 Reasearch Vice-Chancellor- Tabriz University of Medical Sciences Comparison of the effect of TheraCal-LC® and Mineral Trioxide Aggregate in direct pulp capping of primary molars in 5-8 year old children. Comparison of the effect of TheraCal-LC® and Mineral Trioxide Aggregate in direct pulp capping of primary molars in 5-8 year old children. A split-mouth randomized controlled clinical Trial . 2016-10-06 anticipated 90 Complete https://irct.ir/trial/3212 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: For this split mouth randomized controlled clinical trial study, symmetrical bilateral second primary molar teeth in maxilla or mandible were chosen in each patient according to the inclusion criteria. In each patient one of the bilateral second primary molars was allocated to group “A” (i.e. TheraCal-LC group) and the other one to group “B” (MTA group) randomly. N/A dental caries. Intervention 1: Study group: The effect of TheraCal LC (Bisco Inc., Schamburg, IL, USA) 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 light-cured for 20 seconds. 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.
public Dr Ali Vafai
Pediatric Dentistry department,Dentistry faculty, Tabriz University of Medical Sciences , Golgasht street, Tabriz
Tabriz Iran (Islamic Republic of) +98 41 3335 5965 alivafaiitbzmed@gmail.com Dentistry faculty, 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) +98 41 3335 5965 leilaerfan@gmail.com Dentistry faculty, Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 5-8 years old children; 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; Having a pair of symmetric second primary molar teeth in one jaw having deep caries and vital pulp which is 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; 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. Exclusion criteria: Lack of informed consent by the child patient’s parent; No evidence of pulp exposure at the site of caries excavation in 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; Abnormal bleeding at the site of pulp exposure (i.e. bleeding with dark color which lasts for more than 3 minutes despite application of wet cotton pellet with mild pressure). 3 years 8 years Both K02.1 Caries of dentine Treatment - Other Treatment - Other Study group: The effect of TheraCal LC (Bisco Inc., Schamburg, IL, USA) 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 light-cured for 20 seconds. 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 2016-12-26 Ethics Commitee of Research Department - Tabriz University of Medical Sciences Research Department- Tabriz University of Medical Sciences- Golgasht street- Tabriz- Iran Tabriz Iran (Islamic Republic of)