]>
IRCT20181226042132N1 IRCT 2019-05-05 Shiraz University of Medical Sciences Evaluation of the effect of intracanal medicaments against root canal bacteria of infected primary molar tooth Antimicrobial Effect of intracanal medicaments(Triple Antibiotic Paste and Calcium hydroxide) Against E.Faecalis Bacteria in infected primary molars by Real-Time PCR :A Randomized Clinical Trial 2018-12-22 anticipated 39 Complete https://irct.ir/trial/36341 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The children will be randomly divided into three groups (according to block randomization) depending on type of intracanal medicament. Blocks will be then randomly chosen to determine the patients’ assignment into the groups. The group allocation will be revealed by an assistant not directly involved in the study only after each patient is seated for the initial appointment and a random code number will be assigned to each patient at the beginning of study, Blinding description: The patients and the data evaluators are blinded with respect to the type of intracanal medicament used. 2-3 Infection of primary molars. Intervention 1: Intervention group1:triple antibiotic paste containig minocycline ,ciprofloxacin and metronidazole,once between sessions for 7 days in the root canal system. Intervention 2: Intervention group 2: Calcium Hydroxide,once between sessions for 7 days in the root canal system. Intervention 3: Control group: No medicament; rinsing with normal saline and using a piece of cotton pellet in pulp chamber between treatment sessions. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no more information
public Dordaneh Ghaffaripour
Shiraz school of dentistry, Mehr Blvd, Ghasredasht
Shiraz Iran (Islamic Republic of) 7195615898 +98 71 3626 3194 dghaffaripour@yahoo.com Shiraz University of Medical Sciences scientific Najmeh Mohammady
Shiraz school of dentistry, mehr Blvd, ghasredasht
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3194 Mohammadyn@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Children with infected primary molars tooth with periapical radiolucent lesion 4 years 6 years Both Children should not recieve any antibiotic since 1 month before the treatment session. K04.1 Necrosis of pulp Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1:triple antibiotic paste containig minocycline ,ciprofloxacin and metronidazole,once between sessions for 7 days in the root canal system Intervention group 2: Calcium Hydroxide,once between sessions for 7 days in the root canal system Control group: No medicament; rinsing with normal saline and using a piece of cotton pellet in pulp chamber between treatment sessions Changes in Bacteria count in the root canals of infected teeth. Timepoint: Bacteria count at the beginning and 7 days after each two type of intervention. Method of measurement: Polymerase Chain Reaction. Success rate of treatment after applying each intracanal medicament. Timepoint: recording the clinical status(pain,mobility,swelling,..)and radigraphy(extension of the radiolucent lesion,bone resorption,...)at the begining before the intervention and then two months after the treatment. Method of measurement: examination and record of pain history,mobility grade(1,2,3), examination of swelling status,bone density measurement from radiography. Shiraz University of Medical Sciences Approved 2018-12-25 Ethics committee of Shiraz University of Medical Sciences Shiraz school of dentistry, Mehr Blvd, Ghasredasht Shiraz Fars Iran (Islamic Republic of)