Evaluation of antimicrobial efficacy and flare up incidence of Allium Sativum L. extract as an endodontic irrigant following instrumentation in infected teeth: a single blind clinical trial
Evaluation of antimicrobial efficacy and flare up incidence of Allium Sativum L. extract as an endodontic irrigant following instrumentation in infected teeth: a single blind clinical trial
Design
Clinical trial with 2 group of Allium Sativum L. extract or sodium hypochlorite; there are 20 teeth in each group which are randomly allocated and the study is single blinded
Settings and conduct
Patients who referred to the endodontic clinic of Mashhad dental school
one canal necrotic teeth with chronic apical periodontitis
Participants/Inclusion and exclusion criteria
Patients who have at least one necrotic,one canal tooth with chronic apical periodontists are included in this study
Teeth with calcified pulp chamber, teeth that can not be isolated with rubber dam, patients with immune-suppresive diseases and patients taking antibiotic befor or during trearment are excluded in this study
Intervention groups
intervention group:use of Allium Sativum L. extract as an endodontic irrigant
Control group: use of sodium hypochlorite 5.25% as an endodontic irrigant
Main outcome variables
antibacterial effect;pain;swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181103041534N1
Registration date:2018-12-24, 1397/10/03
Registration timing:retrospective
Last update:2018-12-24, 1397/10/03
Update count:0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
Samaneh Hajizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 3916
Email address
hajizadehs941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-09, 1397/08/18
Expected recruitment end date
2018-12-09, 1397/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of antimicrobial efficacy and flare up incidence of Allium Sativum L. extract as an endodontic irrigant following instrumentation in infected teeth: a single blind clinical trial
Public title
Antimicrobial efficacy of Allium Sativum extract as endodontic irrigant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients referring to Mashhad Faculty of dentistry
permanent teeth
one canal
teeth with necrotic pulp
teeth with chronic apical periodontitis
Exclusion criteria:
teeth with calcified pulp chamber
patients with immune-suppresive disease
taking antibiotic before or during treatment
teeth that can not be isolated with rubber dam
Age
From 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization using randomization table
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that Allium Sativum L. extract and sodium hypochlorite have different appearance and physical properties, the operator can not be blind. In this study the patient,microbiologist and data analyzer are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad Faculty of Dentistry
Street address
Azadi SQ
City
Mashhad
Province
Razavi Khorasan
Postal code
9179775133
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.003
Health conditions studied
1
Description of health condition studied
necrosis of pulp
ICD-10 code
K04.1
ICD-10 code description
Necrosis of pulp
Primary outcomes
1
Description
measuring microbial load in each tooth using CFU(colony forming units)
Timepoint
The beginig of the study (before intervention) and 3 days after the interventuon
Method of measurement
Microbial culture and colony forming units count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: use of Allium sativum L. as an endodontic irrigant
Category
Treatment - Drugs
2
Description
Control group: use of sodium hypochlorite az an endodontic irrigant