Effect of Gutta-percha and Mineral Trioxide Aggregate on Post Endodontic Pain in Teeth with Asymptomatic Apical Periodontitis: A Randomized Clinical Trial
The aim of the present study is to determine post endodontic pain score after root canal therapy using gutta-percha alone or Mineral Trioxide Aggregate plug with gutta-percha in teeth with asymptomatic apical periodontitis.
Design
A randomized clinical trial with control group, parallel groups, single-blinded.
Settings and conduct
This study will be done in the Faculty of Dentistry Islamic Azad University of Isfehan(Khorasgan). Among patients who enter for root canal therapy, the ones that have asymptomatic apical periodontitis will be chosen. If they sign the informed consent form they will enter the study. Participants are divided into two groups using simple randomization and random number table. Endodontic treatment is similar for both groups except that in one group canal is filled with gutta-percha and the other group, the canal is filled with MTA and gutta-percha. For blinding, a pair of opaque glasses will be worn on the participants' eyes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 18 to 65 years old with asymptomatic apical periodontitis teeth.
Exclusion criteria: Usage of pain killer during the last 12 hours
Intervention groups
Patients who need root canal therapy will be divided into two groups. Root canal therapy will be done with gutta-percha for one group and Mineral Trioxide Aggregate plug and gutta-percha for the other group.
Main outcome variables
Post endodontic pain score will be measured in 6, 12, 24, 48, and 72 hours after intervention for each group.
Post endodontic pain scores will be compared between two groups at the same time intervals after an intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191104045331N1
Registration date:2020-10-27, 1399/08/06
Registration timing:retrospective
Last update:2020-10-27, 1399/08/06
Update count:0
Registration date
2020-10-27, 1399/08/06
Registrant information
Name
sahel kamgar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 8406
Email address
sahelkamkar93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
2018-05-20, 1397/02/30
Actual recruitment end date
2019-04-08, 1398/01/19
Trial completion date
2019-06-13, 1398/03/23
Scientific title
Effect of Gutta-percha and Mineral Trioxide Aggregate on Post Endodontic Pain in Teeth with Asymptomatic Apical Periodontitis: A Randomized Clinical Trial
Public title
The effect of obturation materials on post endodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and to understand the questionaire
Singniture of the informed consent form
Patients between 18 to 65 years old
Tooth with asymptomatic apical periodontitis confirmed with cold test and radiography
Restorable tooth
Periapical index of 3, 4 or 5
Exclusion criteria:
Presence of a sinus tract
Mandibular second premolar
Retreatment cases
Usage of pain killer during the last 12 hours
Tooth with no occlusal contact
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants will be divided into two groups using a permuted block randomization method. Randomization will be done using 25 blocks with a 4-factor design. In each factor of the block design two participants are assigned to the control group and two participants to the intervention group. Then 25 numbers, from 1 to 6 will be selected using randomization table. For allocation concealment, the type of groups will be given to participants according to the block order via opaque envelopes by a person who is not aware of the randomization procedure. The canals of the teeth will be filled with gutta-percha in the control group and MTA with gutta-percha in the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Using a pair of opaque glasses on participants' eyes during treatment so that the patients won't be able to see the treatment procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch
Street address
Islamic Azas Univesity of Isfehan (khurasgan) Branch, Isfehan, East Jey street, Arghavaniye, Daneshgah Boulevard
City
Isfehan
Province
Isfehan
Postal code
8155139998
Approval date
2019-07-03, 1398/04/12
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.075
Health conditions studied
1
Description of health condition studied
Asymptomatic apical periodontitis
ICD-10 code
K04.5
ICD-10 code description
Chronic apical periodontitis
Primary outcomes
1
Description
Score of pain in the questionnaire
Timepoint
6, 12, 24, 48 and 72 hours after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For teeth with asymptomatic apical periodontitis, after cleaning and shaping, root canal therapy will be done with a thickness of three to five millimeters of ProRoot Mineral Trioxide Aggregate (Dentsply) plug. The rest of the canal will be filled with gutta-percha (Meta Biomed).
Category
Treatment - Other
2
Description
Control group: For teeth with asymptomatic apical periodontitis ,after cleaning and shaping, root canal therapy will be done with gutta-percha (Meta Biomed).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry Islamic Azad University of Isfehan (Khorasgan) Branch
Full name of responsible person
Sahel Kamgar
Street address
Isfehan, East Jey street, Arghavaniye, Daneshgah Boulevard
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Sahel Kamgar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Isfehan, East Jey street, Arghavaniye, Daneshgah Boulevard
City
Isfehan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
Info@khuisf.ac.ir
Web page address
https://www.khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbasali Khademi Mooghari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfehan, Hezar jarib street, Isfehan University of Medical Sciences
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3669 9357
Email
a_khademi@dnt.mui.ac.ir
Web page address
https://dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Khabiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfehan, East Jet street, Arghavaniye, Daneshgah Boulevard
City
Isfehan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 5300 2148
Fax
+98 31 3535 4060
Email
khabiri-m-d@yaoo.com
Web page address
https://khuisf.ac.ir
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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participants data (pain score, sex and involving jaw without names of participants), study protocol, statistical analysis plan, informed consent form and study report will be shared.
When the data will become available and for how long
Documents and data files will be available after publishing the article and will always be available.
To whom data/document is available
People working in academy institutions
Under which criteria data/document could be used
Educational and research uses
From where data/document is obtainable
From the library of Faculty of Dentistry Islamic Azad University of Isfehan (Khorasgan).
What processes are involved for a request to access data/document
A formal request should be given to the library of Faculty of Dentistry Islamic Azad University of Isfehan (Khorasgan) and the data will be given to them.