Comparison of the effect of intracanal drugs on calcium hydroxide blend with nano silver particles and calcium hydroxide blend and normal saline on pain relief between root canal therapy in patients with symptomatic apical periodontitis
Comparison of the effect of calcium hydroxide with nano-silver particles and calcium hydroxide and normal saline as intracanal medications on pain between sessions in premolar teeth with symptomatic apical periodontitis.
Design
In this single-blind randomized clinical trial study, 30 patients with healthy systemic conditions and premolar teeth with pulp and periapical conditions requiring root canal treatment with symptomatic apical periodontitis were selected.
Patients were divided into 3 parallel 10-person groups including study and control groups, and patients in each group received different root canal medications.
To choose intracanal medication 10 numbers of each intracanal medications were written on identical pieces of paper then asked the assistant to one sheet of paper for each patient .
Settings and conduct
Study Area: Dental Clinic, Faculty of Dentistry, Army University of Medical Sciences.
pain between the root canal treatment sessions was measured using visual analogue scale (VAS) and its relationship with intracanal medications was evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patient with premolar tooth with closed apex and symptomatic apical periodontitis.
Non-inclusion criteria: pregnancy; Not repairable teeth; presence of any resorption; systemic disease; history of chronic use of Analgesics, drugs or alcohol; using antibiotics and pretreatment analgesics.
Intervention groups
Intervention group 1: mixture of calcium hydroxide with silver nano particles.
Intervention group 2: Mixture of calcium hydroxide with normal saline.
Control group: Sterile dry cotton pellet.
Standard root canal treatment was performed for patients in two sessions and at the end of the first session, the intracanal medications were used for patients in the study groups.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190323043102N1
Registration date:2020-03-14, 1398/12/24
Registration timing:retrospective
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Mohsen Mortezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
mortezaei73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2019-10-03, 1398/07/11
Actual recruitment start date
2019-07-01, 1398/04/10
Actual recruitment end date
2019-12-30, 1398/10/09
Trial completion date
2019-12-30, 1398/10/09
Scientific title
Comparison of the effect of intracanal drugs on calcium hydroxide blend with nano silver particles and calcium hydroxide blend and normal saline on pain relief between root canal therapy in patients with symptomatic apical periodontitis
Public title
Effect of nano silver particles on pain control between root canal therapy sessions in premolar teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient seeking root canal treatment
closed apex
Exclusion criteria:
Systemic disease
tooth with internal or external resorption
Use of antibiotics and analgesics before treatment
pregnancy
Non-repairable teeth
A history of chronic use of analgesics, narcotic or alcohol
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were categorized by an assistant using random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
number 1 was assigned to calcium hydroxide with nano silver particles , number 2 was assigned to calcium hydroxide , number 3 was assigned to sterile dry cotton pellet.
Then, on behalf of the intracanal drug type, 10 numbers of each intracanal medication were written on identical so that the numbers could not be identified. The papers were poured into a box and we asked the ward assistant to remove one sheet of paper for each patient and enter it into the file.
The patient and data analyzer were unaware of the root canal drug type and after data collection, the number assigned to each intracanal medication was reported to the data analyzer instead of the type of intracanal medication.
Placebo
Used
Assignment
Parallel
Other design features
Silver nano particles are a new material in dentistry and most of the studies on this material are about its antibacterial properties. Microorganisms are the main cause of pain between root canal treatment sessions with apical periodontitis. So we decided to design a study about the relation of the pain between root canal therapy sessions and nano silver particles.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, Etemadzade avenue., West Fatemi boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
6523545522
Approval date
2019-01-28, 1397/11/08
Ethics committee reference number
IR.AJAUMS.REC.1397.082
Health conditions studied
1
Description of health condition studied
Pain between root canal treatment sessions
ICD-10 code
K04.4
ICD-10 code description
Acute apical periodontitis of pulpal origin
Primary outcomes
1
Description
Post-treatment pain above 3
Timepoint
between two root canal sessions at 6, 12 , 24 and 48 hours after first session (2 session root canal with intracanal medication )
Method of measurement
Visual analog scale (VAS): patients are asked to mark the pain level at 6, 12 , 24 and 48 hours after first session of their treatment then the 10 cm line of each period was measured from left(no pain) in millimeter.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In patient's premolar teeth with symptomatic apical periodontitis, calcium hydroxide with silver nano particles was used as intracanal medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days.
Category
Prevention
2
Description
Intervention group 2: In patient's premolar teeth with symptomatic apical periodontitis, calcium hydroxide with normal saline was used as intracanal medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days.
Category
Prevention
3
Description
Control group: In patient's premolar teeth with symptomatic apical periodontitis, sterile dry cotton pellet was used as placebo medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry college of AJA University of Medical Science
Full name of responsible person
Mohsen Mortezaei
Street address
Misagh complex, East 13 alley, Sabari street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2266 7637
Email
mmortezaei7777@gmail.com
Web page address
http://dentistry.ajaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Majid Ajami
Street address
Misagh complex, East 13 alley, Sabari street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2266 7637
Email
mmortezaei7777@gmail.com
Web page address
http://www.ajaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mohsen Mortezaei
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.27 ,Etemadzade sreet, West Fatem street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
0098216-86096350
Email
mmortezaei7777@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Majid Ajami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Artesh University of Medical Sciences, East Alley St., Adjouani Ave.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
0098 21 228998983
Email
dr_ajami2@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohsen Mortezaei
Position
dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 28; Aghaghia Tower; No 27; Etemadzadeh avenue; West Fatemi street
City
Tehran
Province
Tehran
Postal code
10140760008
Phone
+98 21 8765 1413
Email
mmortezaei7777@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Patient record, file summary, visual analogue scale (VAS) form, and 5 periapical graphs of patients are available which can be published if necessary after deleting patients' names and telephone numbers.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Those who are researching silver nanoparticles
Comparison of pain levels between sessions in the upper and lower jaw
Comparison of pain between sessions between men and women
From where data/document is obtainable
mmortezaei7777@gmail.com
Department of Endodontics, Faculty of Dentistry, Army University of Medical Sciences
What processes are involved for a request to access data/document
The reason for the data request should be verified by the endodontic department.