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IRCT20200509047374N1 IRCT 2020-05-17 Zahedan University of Medical Sciences Evaluation of the clinical effects of nanohydroxy apatite toothpaste during home bleaching treatment Evaluation of Effect of toothpaste containing nanohydroxyapatite particles on dental sensitivity , color change and Gingival Index during home bleaching treatment 2020-06-21 anticipated 40 Complete https://irct.ir/trial/48005 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Allocation Rule Method (In this method, a block of 40 people is considered for sample size and 40 balls with numbers 1 to 40 are placed in one container and the first 20 balls are randomly removed and their sequence is recorded. And are placed in the first group and the remaining 20 items are placed in the second group, so that the balance in the number of people allocated in the groups will be obtained at the end of the study) will be placed in one of the two study groups, Blinding description: In order to simulate toothpaste, due to the similarity of the outer coating of the tube, the outer coating of the toothpaste is removed and the same coatings are placed and coded (by the instructor). Toothpaste will be unspecified for participants and students(Consequence Assessor). 3 Tooth sensitivity after bleaching. Intervention 1: Control group: Do prophylaxis with oil-free prophylactic paste, to remove foreign pigments one week before bleaching treatment, teaching how to brush and floss correctly (brush 3 times a day at the right time, noon, night and floss once a night), prepare a template Alginate, made by each vacuum-specific home remover by vacuum device, uses a tri-containing carbamide proxide bleaching gel with 16% whiteness perfect (FGM Dental-products, Joinville, Sc, brazil) for 4 hours a day for up to 14 days and uses common toothpaste ( Pharmad Total Care Toothpaste 100 mg, Dr. Akhavi Laboratory Company in Tehran, Made in Iran) during the period of use of a tar containing bleaching agents, delivery one anti-sensitivity tube UltraEz(Opalescencc, USA) and a number of codeine acetaminophen tablets (/ 10mg300) for pain relief medications. Intervention 2: Intervention group: Do prophylaxis with oil-free prophylactic paste, to remove foreign pigments one week before bleaching treatment, teaching how to brush and floss correctly (brush 3 times a day at the right time, noon, night and floss once a night), prepare a template Alginate, home-made tri-person trials by vacuum machine, use of tri-containing carbamide proxide bleaching gel 16% whiteness perfect (FGM Dental-products, Joinville, Sc, brazil) for 4 hours a day for up to 14 days and use toothpaste containing 15% of Pharmed Normative Apatite Nanoparticles (Pharmad N-HAP Sensitive Toothpaste 100 mg, Dr. Akhavi Laboratory Company in Tehran, Made in Iran) during Use Bleaching of the more ingredients, deliver a َanti-sensitivity tube UltraEz (Opalescencc, USA) and a number acetaminophen codeine (/ 10mg300) in order to relieve the unbearable pain medications. No - There is not a plan to make this available Justification or reason for not sharing IPD is No need to publish
public Faeze Elahi Chatrudi
Zahedan, East Azadegan St., School of Dentistry
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3341 4004 Nikadp.94@gmail.com Zahedan University of Medical Sciences scientific Dr. Somayeh Hosseini Tabatabai
Iran, Zahedan, Azadegan St., School of Dentistry, Zahedan University of Medical Sciences
Zahedan Iran (Islamic Republic of) 9817966993 +98 54 3341 4004 somayehtabatabaei@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Having natural front teeth with colors A2, B2, C2, D2 and darker (Vitapan Classic Shade) Have at least 24 teeth Lack of any kind of frontal restoration Proper oral hygiene People without caries in the front teeth Lack of Gingivitis and Periodontal Diseases No dental root exposure Lack of NCCL (Non Caries Cervical Lesions) Lack of ortho treatment Patients without a history of dental sensitivity to cold and heat or expressing allergies with airborne powder tests Do not use any anti-sensitivity compounds for the past three months No pregnancy or lactation Lack of Calculus People without a history of bleaching treatment in the past No smoking People without florosis and tetracycline 18 years no limit Both Lack of willingness of the participant to continue treatment Severe sensitivity due to bleaching treatment Z40,Z54 Persons encountering health services for specific procedures and health care Treatment - Drugs Treatment - Drugs Control group: Do prophylaxis with oil-free prophylactic paste, to remove foreign pigments one week before bleaching treatment, teaching how to brush and floss correctly (brush 3 times a day at the right time, noon, night and floss once a night), prepare a template Alginate, made by each vacuum-specific home remover by vacuum device, uses a tri-containing carbamide proxide bleaching gel with 16% whiteness perfect (FGM Dental-products, Joinville, Sc, brazil) for 4 hours a day for up to 14 days and uses common toothpaste ( Pharmad Total Care Toothpaste 100 mg, Dr. Akhavi Laboratory Company in Tehran, Made in Iran) during the period of use of a tar containing bleaching agents, delivery one anti-sensitivity tube UltraEz(Opalescencc, USA) and a number of codeine acetaminophen tablets (/ 10mg300) for pain relief medications Intervention group: Do prophylaxis with oil-free prophylactic paste, to remove foreign pigments one week before bleaching treatment, teaching how to brush and floss correctly (brush 3 times a day at the right time, noon, night and floss once a night), prepare a template Alginate, home-made tri-person trials by vacuum machine, use of tri-containing carbamide proxide bleaching gel 16% whiteness perfect (FGM Dental-products, Joinville, Sc, brazil) for 4 hours a day for up to 14 days and use toothpaste containing 15% of Pharmed Normative Apatite Nanoparticles (Pharmad N-HAP Sensitive Toothpaste 100 mg, Dr. Akhavi Laboratory Company in Tehran, Made in Iran) during Use Bleaching of the more ingredients, deliver a َanti-sensitivity tube UltraEz (Opalescencc, USA) and a number acetaminophen codeine (/ 10mg300) in order to relieve the unbearable pain medications The severity of tooth sensitivity. Timepoint: Days 1, 3, 7, 10 and 14 after the start of bleaching. Method of measurement: based on the VAS (Visual Analog Scale)test. The rate of tooth discoloration. Timepoint: Days 1, 3, 7, 10 and 14 after the start of bleaching. Method of measurement: Chromaticity (color intensity) with Easy shade device. Gingival index. Timepoint: Days 1, 3, 7, 10 and 14 after the start of bleaching. Method of measurement: During a clinical examination with a probe and observing the condition of the gums. Zahedan University of Medical Sciences Approved 2020-04-26 Ethics Committee of Zahedan University of Medical Sciences Iran, Zahedan, Dr. Hesabi Square, Zahedan University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)