Antibacterial effectiveness of Propolis as root canal medicament in human necrotic teeth
Design
Clinical trial with 2 groups of Propolis or Calcium hydroxide; there are 20 teeth in each group which are randomly located and the study is single blinded.
Settings and conduct
Patient who referred to Endodontics Clinic of Mashhad dental school
One canal necrotic teeth with apical peridontitis
Participants/Inclusion and exclusion criteria
Patients who has at least one necrotic, one canal tooth with apical peridontitis
Teeth with calcified pulp chamber and patients who receive antibiotics now
Intervention groups
Propolis or Calcium hydroxide are placed in the root canals of one canal necrotic teeth with apical peridontitis
Main outcome variables
Calcium hydroxide, Propolis, Antibacterial effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180417039337N1
Registration date:2018-09-29, 1397/07/07
Registration timing:retrospective
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Armita Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
rouhania@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antibacterial effect of Propolis as root canal medicament in necrotic teeth: A randomized single-blind clinical trial study
Public title
Antibacterial effect of Propolis in necrotic teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referring to Mashhad Faculty of Dentistry
One canal teeth
Teeth with necrotic pulp
Teeth with chronic apical periodontitis
Exclusion criteria:
Calcified teeth
patients with immune-suppresive diseases
Taking antibiotic and antifungal drugs before treatment
Teeth that in not isolated with rubber dam
Age
From 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
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 Propolis and Calcium hydroxide 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
Faculty of Dentistry, Azadi SQ.
City
Mashhad
Province
Razavi Khorasan
Postal code
9179775133
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
961243
Health conditions studied
1
Description of health condition studied
necrosis of pulp
ICD-10 code
k04.1
ICD-10 code description
k04.1
Primary outcomes
1
Description
measuring microbial load in each tooth using CFU ( colony forming units)
Timepoint
The beginning of the study (before the intervention) and 7 days after the intervention
Method of measurement
Microbial culture and colony forming units count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: use of propolis (Production of Razi Vaccine & Serum Research Institute with concentration determined by MIC and MBC measured in this study) as an intracanal medicament
Category
Treatment - Drugs
2
Description
Control group: Use of calcium hydroxide (Golchadent - Iran) as an intracanal medicament