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
The aim is to evaluate the antimicrobial efficacy of intracanal medicaments including triple paste antibiotic and calcium hydroxide against bacteria in infected primary molars
Design
A randomized clinical trial with control group,parallel groups, double blind
Settings and conduct
The aim of this study is to compare antimicrobial efficacy of calcium hydroxide and triple antibiotic paste as intracanal medicament .Therefore,39children 4-6 years old (pediatric department of shiraz dental school,shiraz university of medical sciences)will be randomly divided into thee groups.First microbiological samples(S1)will be collected from the root canal then one of the aforementioned medicaments will be placed into the root canal according to the groups of the study(except the control group).Seven days later,canals will be irrigated and second bacteriological samples(S2) will be collected.The samples will be incubated and DNA extraction will be performed to count bacteria using real-time PCR.Patients and analyzers are blinded about the intracanal medicament.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Children, aged 4-6 years old with infected primary molars and radiolucent periapical lesions
Exclusion criteria:Children should not recieve any antibiotic at least one month before the treatment session
Intervention groups
Test group1 :Triple antibiotic paste that is inserted into the infected root canal between treatment sessions
Test group2 :Calcium hydroxide that is inserted into the infected root canal between treatment sessions
Control group3 : using just a piece of cotton pellet in pulp chamber without intracanal medicament
Main outcome variables
1.Changes in Bacteria count in the root canals of infected teeth
2.Success rate of treatment after applying each intracanal medicament
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181226042132N1
Registration date:2019-05-05, 1398/02/15
Registration timing:retrospective
Last update:2019-05-05, 1398/02/15
Update count:0
Registration date
2019-05-05, 1398/02/15
Registrant information
Name
Najmeh Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3843 6561
Email address
mohammadyn@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the effect of intracanal medicaments against root canal bacteria of infected primary molar tooth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with infected primary molars
tooth with periapical radiolucent lesion
Exclusion criteria:
Children should not recieve any antibiotic since 1 month before the treatment session.
Age
From 4 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
The patients and the data evaluators are blinded with respect to the type of intracanal medicament used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz school of dentistry, Mehr Blvd, Ghasredasht
City
Shiraz
Province
Fars
Postal code
7195615878
Approval date
2018-12-25, 1397/10/04
Ethics committee reference number
IR.SUMS.REC.1397.828
Health conditions studied
1
Description of health condition studied
Infection of primary molars
ICD-10 code
K04.1
ICD-10 code description
Necrosis of pulp
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:triple antibiotic paste containig minocycline ,ciprofloxacin and metronidazole,once between sessions for 7 days in the root canal system
Category
Treatment - Drugs
2
Description
Intervention group 2: Calcium Hydroxide,once between sessions for 7 days in the root canal system
Category
Treatment - Drugs
3
Description
Control group: No medicament; rinsing with normal saline and using a piece of cotton pellet in pulp chamber between treatment sessions
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz school of dentistry
Full name of responsible person
ِDordaneh Ghaffaripour
Street address
Shiraz school of dentistry, Mehr Blvd, Ghasredasht
City
shiraz
Province
Fars
Postal code
7194734684
Phone
+98 71 3627 7233
Email
dghaffaripour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Faghihi
Street address
Shiraz school of dentistry, Mehr Blvd, Ghasredasht
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3194
Email
dghaffaripour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dordaneh Ghaffaripour
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shiraz school of dentistry, Mehr Blvd, Ghasredasht
City
Shiraz
Province
Fars
Postal code
7195615898
Phone
+98 71 3626 3194
Email
dghaffaripour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Mohammady
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz school of dentistry, mehr Blvd, ghasredasht
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3194
Email
Mohammadyn@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dordaneh Ghaffaripour
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shiraz school of dentistry, mehr Blvd, ghasredasht
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3194
Fax
Email
dghaffaripour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available