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IRCT20170715035087N1 IRCT 2018-04-07 Zahedan University of Medical Sciences The effect of laser for the therapy of microbial infection in the root of teeth The effect comparison of the diode laser 940 nm and triple antibiotic on Minocycline resistance genes (Tet M , Tet W , Tet L ) in Enterococcus faecalis isolated from primary root canal infections 2018-04-21 anticipated 150 Complete https://irct.ir/trial/28227 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients was randomly assigned to 1 of the 3 designated groups. Randomization was developed to eliminate any bias on the part of the investigators and to balance the number of patients between the treatment protocol types. Using an equal proportion randomization allocation ratio, 1 of the investigators (A.G.) created envelopes that contained concealed assignment codes that were assigned sequentially to eligible patients. It was ensured that neither the primary investigator nor the patient was aware of the treatment protocol. 2 Infection of root canal system. Intervention 1: Laser therapy with a 2-watt diode laser(EPIC X ,BIOLASE,Irvine,CA 92618, USA) is used continuously and for each canal three times in one session.laser tip(EZTIP400&300). Intervention 2: laser and medication: First, laser diode (EPIC X ,BIOLASE,Irvine,CA 92618, USA)is shoot,The laser tip enters Only in the first session, three times,in root canal then the triple antibiotic will be dress in the root canal for a week.Triple antibiotic paste using the ratio: two tablets of metronidazole 250mg (Tehran chemie), two ciprofloxacin 250 mg tablets (Daroupakhsh-Tehran-Iran) and 5 tablets of minocycline 100 mg (Iran darou) to achieve a 1: 1: 1 ratio , Combined). Intervention 3: Control group: triple antibiotic;Triple antibiotic paste using the ratio: two tablets of metronidazole 250mg (Tehran chemie), two ciprofloxacin 250 mg tablets (Daroupakhsh-Tehran-Iran) and 5 tablets of minocycline 100 mg (Iran darou) to achieve a 1: 1: 1 ratio , Combined) The drug enters the canal with Lentulo, it remains within the root canal For a week. Yes - There is a plan to make this available What will be shared: Part of the individual data and information with the outcomes including the counting of bacteria and the prevalence of faecalis in the root canal and the occurrence of antibiotic resistance genes could be shared When: 6 months after printing results To whom: Researchers working in academia and scientific institutions Conditions: In order to replicate scientific studies and development, data can be used Where to obtain: To the corresponding author How to obtain: Administrative correspondence through the deputy of research and technology Comments:
public Forough Farahi
School of Dentistry,East Azadegan Street, Zahedan,
Zahedan Iran (Islamic Republic of) 9816864997 +98 54 3342 3141 f_farahi67@yahoo.com Zahedan University of Medical Sciences scientific Eshaghali saberi
School of Dentistry, Azadegan Street, Zahedan
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1824 saberiendo@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) The patients with age ranges from 15 to 60 years who visit the Department of Endodontics at the Faculty of Dentistry in Zahedan, and are diagnosed as "necrotic pulp" with and without periapical involvement after having performed the vitality test The patients whose teeth are closed apex, with no connection between canal pulp and oral cavity The patients with no medical records in endodontic treatment, root resorption, calcification, and periodontal pocket with the depth at least 5 mm. The patients who have not been hospitalized within last three months and have not consumed antibiotics 15 years 60 years Both The observation of necrotic pulp after entering the pulp chamber and root canal, or due to the traumatic necrosis The inability to isolate the tooth which results in the contamination of the treatment environment by saliva Pregnancy Patients who remember taking antibiotics during treatment The patient's disinterest in participating in the study B99 Other and unspecified infectious diseases Treatment - Drugs Treatment - Drugs Treatment - Drugs Laser therapy with a 2-watt diode laser(EPIC X ,BIOLASE,Irvine,CA 92618, USA) is used continuously and for each canal three times in one session.laser tip(EZTIP400&300) laser and medication: First, laser diode (EPIC X ,BIOLASE,Irvine,CA 92618, USA)is shoot,The laser tip enters Only in the first session, three times,in root canal then the triple antibiotic will be dress in the root canal for a week.Triple antibiotic paste using the ratio: two tablets of metronidazole 250mg (Tehran chemie), two ciprofloxacin 250 mg tablets (Daroupakhsh-Tehran-Iran) and 5 tablets of minocycline 100 mg (Iran darou) to achieve a 1: 1: 1 ratio , Combined) Control group: triple antibiotic;Triple antibiotic paste using the ratio: two tablets of metronidazole 250mg (Tehran chemie), two ciprofloxacin 250 mg tablets (Daroupakhsh-Tehran-Iran) and 5 tablets of minocycline 100 mg (Iran darou) to achieve a 1: 1: 1 ratio , Combined) The drug enters the canal with Lentulo, it remains within the root canal For a week Number of bacteria in the root canal. Timepoint: before intervention, after intervention. Method of measurement: real time PCR. Investigation and expression of minocyclin resistant genes in Enterococcus faecalis. Timepoint: before intervention, after intervention. Method of measurement: PCR. Zahedan University of Medical Sciences Approved 2017-10-08 Ethics committee of Zahedan university of medical sciences Dr Hesabi Square, Zahedan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)