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IRCT201609226105N6 IRCT 2016-11-14 Vice Chancellor for Research and Technology of Zahedan University of Medical Sciences Clinical and radiographic success of pulpotomy in primary molars restored with glass ionomer- crown Evaluation of clinical and radiographic success of pulpotomy in primary molars restored with glass ionomer- crown: A double-blind randomized clinical trial 2016-12-29 anticipated 55 Complete https://irct.ir/trial/6554 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment. N/A Dental Caries. Intervention 1: Intervention 1 Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) for 60 seconds, administration mandibular block anesthesia by delivering 1 mL of lidocaine 2% with epinephrine 1:80000 (Psocaine-E, Darou Pakhsh IND. CO Iran) within 1.5 minutes, rubber dam isolation, caries removal, access cavity preparation with high speed hand piece using water spray, coronal pulp excision using a sharp spoon excavator, rinsing with 5 mL normal saline (Darou Pakhsh IND. CO, Iran) bleeding control and establishing hemostasis with light pressure applying by cotton pellet for 5 minutes, fixing pulp stumps with 1/5 dilution Buckley formocrezole solution (Buckley’s FormoCresol® SultanHealthcare, Hackensack, NJ) for 1 minutes, placing fast setting zinc oxide eugenole (Zoliran, Golchadent CO, Iran) a pulp dressing material, restoring tooth crown at the same appointment by stainless steel crown (3M/ ESPE. St. Paul MN, USA) using luting glass ionomer cement (GC America, Inc., Alsip, IL, USA). Intervention 2: مداخله 2 اعمال ژل بي حسي موضعي (TOPEX, Sultan Healthcare IND. CO, USA) به مدت 60 ثانيه، انجام بي حسي بلوک منديبل با تزريق 1 ميلي ليتر از محلول ليدوکائين 2% با اپي نفرين 80000/1 (Persocaine-E, Darou Pakhsh IND. CO, Iran) طي زمان 5/1 دقيقه، ایزولاسیون با رابردم، حذف پوسیدگی، تهیه حفره دسترسی با توربین با سرعت بالا و اسپری آب، قطع پالپ تاجی با اکسکاواتور قاشقی تیز، شستشو با 5 میلی لیتر نرمال سالین (Darou Pakhsh IND. CO, Iran)،کنترل خونریزی و ایجاد هموستاز با فشار ملایم گلوله پنبه به مدت 5 دقیقه، فیکس کردن پالپ ناحیه اریفیس با محلول فرموکرزول باکلی (Buckley’s FormoCresol® SultanHealthcare, Hackensack, NJ) با رقت یک پنجم به مدت 1 دقیقه، قرار دادن سمان زینک اکساید اوژنول زود سخت شونده (Zoliran, Golchadent CO, Iran) بعنوان ماده پوشاننده پالپ، ترمیم تاج در همان جلسه با استفاده از گلاس آینومر ترمیمی (GC America, Inc., Alsip, IL, USA) به عنوان ترمیم بازسازی تاج، قرار دادن روکش استینلس استیل (3M/ ESPE. St. Paul MN, USA) با استفاده از سمان گلاس آینومر لوتینگ (GC America, Inc., Alsip, IL, USA).
public Nahid Ramazani
Azadegan avenue
9817699691 Iran (Islamic Republic of) 9817699691 +98 54 3341 4005 ramazani_nahid@yahoo.com Zahedan University of Medical Sciences scientific Nahid Ramazani
School of Dentistry, Department of Pediatrics
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3341 4005 ramazani77@gmail.com School of Dentistry Iran (Islamic Republic of) Inclusion criteria :Children between 4-8 years old, require pulpotomy in the primary mandibular second molars, having complete physical and mental health, located in the positive or definitely positive classification of Frankle during behavioral pretreatment assessment, existence of enough crown tissue to repair, nearly the same crown destruction on molars of both sides . Exclusion criteria :Any known allergy to medication or anesthetic solution, any emergency situation or tooth pain with pulp-origin . 4 years 8 years Both B99-B99 Other and unspecified infectious diseases Other Other Intervention 1 Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) for 60 seconds, administration mandibular block anesthesia by delivering 1 mL of lidocaine 2% with epinephrine 1:80000 (Psocaine-E, Darou Pakhsh IND. CO Iran) within 1.5 minutes, rubber dam isolation, caries removal, access cavity preparation with high speed hand piece using water spray, coronal pulp excision using a sharp spoon excavator, rinsing with 5 mL normal saline (Darou Pakhsh IND. CO, Iran) bleeding control and establishing hemostasis with light pressure applying by cotton pellet for 5 minutes, fixing pulp stumps with 1/5 dilution Buckley formocrezole solution (Buckley’s FormoCresol® SultanHealthcare, Hackensack, NJ) for 1 minutes, placing fast setting zinc oxide eugenole (Zoliran, Golchadent CO, Iran) a pulp dressing material, restoring tooth crown at the same appointment by stainless steel crown (3M/ ESPE. St. Paul MN, USA) using luting glass ionomer cement (GC America, Inc., Alsip, IL, USA). مداخله 2 اعمال ژل بي حسي موضعي (TOPEX, Sultan Healthcare IND. CO, USA) به مدت 60 ثانيه، انجام بي حسي بلوک منديبل با تزريق 1 ميلي ليتر از محلول ليدوکائين 2% با اپي نفرين 80000/1 (Persocaine-E, Darou Pakhsh IND. CO, Iran) طي زمان 5/1 دقيقه، ایزولاسیون با رابردم، حذف پوسیدگی، تهیه حفره دسترسی با توربین با سرعت بالا و اسپری آب، قطع پالپ تاجی با اکسکاواتور قاشقی تیز، شستشو با 5 میلی لیتر نرمال سالین (Darou Pakhsh IND. CO, Iran)،کنترل خونریزی و ایجاد هموستاز با فشار ملایم گلوله پنبه به مدت 5 دقیقه، فیکس کردن پالپ ناحیه اریفیس با محلول فرموکرزول باکلی (Buckley’s FormoCresol® SultanHealthcare, Hackensack, NJ) با رقت یک پنجم به مدت 1 دقیقه، قرار دادن سمان زینک اکساید اوژنول زود سخت شونده (Zoliran, Golchadent CO, Iran) بعنوان ماده پوشاننده پالپ، ترمیم تاج در همان جلسه با استفاده از گلاس آینومر ترمیمی (GC America, Inc., Alsip, IL, USA) به عنوان ترمیم بازسازی تاج، قرار دادن روکش استینلس استیل (3M/ ESPE. St. Paul MN, USA) با استفاده از سمان گلاس آینومر لوتینگ (GC America, Inc., Alsip, IL, USA) Clinical success. Timepoint: 6 months after intervention 1 and 2. Method of measurement: using described criteria of successful clinical treatment including no swelling, tenderness to percussion, tenderness to palpation, mobility, fistula and abscess. Radiographic success. Timepoint: 6 months after intervention 1 and 2. Method of measurement: using described criteria of successful radiographic treatment including no PDL widening, loss of lamina dura, radiolucency of furcation, internal or external root resorption, supporting bone destruction, pre apical radiolucency. Vice Chancellor for Research and Technology of Zahedan University of Medical Sciences Approved 2016-07-31 Ethics Committee of Zahedan University of Medical Science Zahedan, Persian Gulf Blvd., College, resistance Research and Technology Zahedan Iran (Islamic Republic of)