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IRCT20190122042457N1 IRCT 2019-03-03 Hamedan University of Medical Sciences effect of diode laser on postoperative sensitivity in composite restorations Effect of diode laser (940nm) on postoperative sensitivity in class II composite restorations (randomized clinical trial, double blind) 2018-09-15 anticipated 30 Complete https://irct.ir/trial/37162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done using the numerical randomization table.In a patient with two decayed premolar teeth, one is randomly designate in the intervention(laser) group and the other one allocate in the control group. The randomized table of numbers is generated by computers that customize the numbers randomly in multiple columns and rows. Examples of these tables are available on the Internet and statistical books. After get the table, the number is selected by closing the eye and inserting the finger or tip of the pen on the point of the table and moving to the right and the numbers on the path are recorded, this is repeated until 30 samples were obtained for 30 patients in the study, respectively. So if the selected number is even, the left tooth is considered as a lasers group and the right tooth is considered as the control group. And if the number is odd, the right tooth is considered as a lasers group and the left tooth is considered as the control group, Blinding description: The patient is kept blinded by receiving placebo radiation in the control tooth. The practitioner and who perform the sensitivity test are two individuals in this study. So the practitioner will carry out the intervention treatment. and the examiner blindly tests the teeth sensitivity at the follow-up sessions until the end of the study. N/A Tooth sensitivity. Intervention 1: Control group: After cavity preparation and just before the restoration placement, the tooth in the control group is subjected to placebo irradiation from red light for 30 s. Etching and bonding procedures are done by a self-etch adhesive (Single Bond Universal, 3M ESPE ,USA) according to the manufacturer’s instructions, and then the class II cavities is restored by a resin composite (Filtek Z250 , 3M ESPE ,USA) by incremental technique. After curing, finishing is accomplished with fine-grit diamond burs (Brasseler) and Sof-Lex polishing disc system (3MESPE, St Paul,MN, USA) underwater cooling to obtain a smooth surface. Intervention 2: Intervention group: . After cavity preparation and just before the restoration placement, the teeth in the experimental group is subjected to irradiation from a low-level red laser (Ezlase 940, Biolase, California, USA), emitting a wavelength of 940 nm in a continuous pulse using E4 tip. The output power of the apparatus is1W, and each tooth is irradiated for 30 s.Etching and bonding procedures were done by a self-etch adhesive (Single Bond Universal, 3M ESPE ,USA) according to the manufacturer’s instructions, and then the class II cavities is restored by a resin composite (Filtek Z250 , 3M ESPE ,USA) by incremental technique. After curing, finishing is accomplished with fine-grit diamond burs (Brasseler) and Sof-Lex polishing disc system (3MESPE, St Paul,MN, USA) underwater cooling to obtain a smooth surface. Yes - There is a plan to make this available What will be shared: Non-identifiable individual data, participants protocol, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in the analysis, and classification system (data dictionary) after the end of the study and after publication of the article will be published on this site. When: Six months after the publication of the article To whom: All people will have access to information Conditions: Data is available for study by other dentists and researchers on clinical trials data with the mention of the source. Where to obtain: To get the data, Refer to the person responsible for the study: Mojgan Taheri, email: taheri.mojgan.86@gmail.com, 00989183152146 How to obtain: The applicant, after disclosure of the name and contact information, and the research center, should explain a summary of his research topic and how to use the data, and ensure that after using the data, the source will be mentioned. Comments:
public Mojgan Taheri
Hamadan University of Medical Sciences, Shahid Fahmideh St,
Hamadan Iran (Islamic Republic of) 6517838677 +98 81338381026 taheri.mojgan.86@gmail.com Hamedan University of Medical Sciences scientific Logman Rezaei Sofi
Faculty of dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St
Hamadan Iran (Islamic Republic of) 6517838677 +98 81 3838 1086 loghmansofi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients should have two decayed premolar teeth at a proximal surface in right and left side of the mandible or maxilla. Teeth should have Class II caries in the mesial or distal. (Depth about 2 mm and less than 4 mm Bacolingual extent) Teeth should be vital with no traumatic history The teeth should not have cervical caries The teeth should not have any previous fillings. The teeth should not have a history of hypersensitivity and pulpitis The patient should not take the analgesic medication 72 hours before the test Patients should have no systemic disease that affect their periodontal and dental conditions; like Diabetes. 20 years 35 years Both deep carious lesions on teeth that need base and liner. the patient has used toothpaste and anti-allergic solution over the past two months. The patient uses anti-inflammatory and analgesic drugs routinely. The patient has allergies to the restorative material in this study The patient has a history of neurological and psychological illnesses. The patient has very weak dental hygiene and rapid progression of caries. The patient has a history of disease or periodontal surgery in the selected tooth. K03.89 Other specified diseases of hard tissues of teeth Treatment - Devices Treatment - Devices Control group: After cavity preparation and just before the restoration placement, the tooth in the control group is subjected to placebo irradiation from red light for 30 s. Etching and bonding procedures are done by a self-etch adhesive (Single Bond Universal, 3M ESPE ,USA) according to the manufacturer’s instructions, and then the class II cavities is restored by a resin composite (Filtek Z250 , 3M ESPE ,USA) by incremental technique. After curing, finishing is accomplished with fine-grit diamond burs (Brasseler) and Sof-Lex polishing disc system (3MESPE, St Paul,MN, USA) underwater cooling to obtain a smooth surface. Intervention group: . After cavity preparation and just before the restoration placement, the teeth in the experimental group is subjected to irradiation from a low-level red laser (Ezlase 940, Biolase, California, USA), emitting a wavelength of 940 nm in a continuous pulse using E4 tip. The output power of the apparatus is1W, and each tooth is irradiated for 30 s.Etching and bonding procedures were done by a self-etch adhesive (Single Bond Universal, 3M ESPE ,USA) according to the manufacturer’s instructions, and then the class II cavities is restored by a resin composite (Filtek Z250 , 3M ESPE ,USA) by incremental technique. After curing, finishing is accomplished with fine-grit diamond burs (Brasseler) and Sof-Lex polishing disc system (3MESPE, St Paul,MN, USA) underwater cooling to obtain a smooth surface. The sensitivity of the tooth after the cold test by using the Visual analog scale. Timepoint: baseline measurement before filling teeth, one day,two week and One month after treatment. Method of measurement: To do a cold test, a swab sprayed with cold spray and placed in the center of the teeth for 5 seconds. The patient is then asked to select 0 to 10 numbers by Visual Analogue Scale to report the severity of pain, so that he will score 10 for the most pain and choose 0 for no pain. Tooth sensitivity to different stimuli. Timepoint: baseline measurement before filling teeth, one day, two week and One month after treatment. Method of measurement: Questionnaire-The patient responds yes or no to questions about tooth susceptibility with heat and cold and sweet dishes. Hamedan University of Medical Sciences Approved 2018-06-30 کمیته اخلاق دانشگاه علوم پزشکی همدان Shahid Fahmideh St Hamadan Hamadan Iran (Islamic Republic of)