Protocol summary

Study aim
The aim of this study is to determine the effect of 980 nm low-power laser on postoperative pain after a single-visit endodontic treatment in necrotic mandibular molar teeth with periapical lesion in patients referred college of Dentistry, Islamic Azad University of Tehran in 1399-1400
Design
This will be a randomized triple blind clinical trial.
Settings and conduct
This triple blind clinical trial with randomized allocation is held in Department of Endodontics, Faculty of dentistry, Islamic Azad University, Tehran. The randomization process is performed by the investigator, and the information about the sample intervention is stored in sealed envelopes. Care provider (endodontist) and investigator (dental student) are aware of the group allocation and process. After treatment in intervention group low level laser therapy and in control group no laser will be applied and the effect on post endodontic pain will be evaluated.
Participants/Inclusion and exclusion criteria
Patients included in this study were those in need for root canal treatment on mandibular molars with pulp necrosis diagnosed with vitality tests and with periapical lesions scoring 2 or 3 in accordance with the periapical index classification introduced by Ørstavik et al, they had no pain with pulpal origin and had pain on percussion with VAS > 56. Patients in good health and systemic condition determined by health history and verbal questioning were included. Exclusion criteria were periodontal probing depth greater than 3 mm, swelling or presence of sinus tract, patients taking analgesia 12 hours prior to intervention, teeth with open apices (immature or inflammatory root resorption) and teeth diagnosed to be non-restorable after the endodontic treatment in primary evaluations.
Intervention groups
Intervention Group: 980 nm low level laser control group: no laser (placebo)
Main outcome variables
post-treatment pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110212005804N7
Registration date: 2020-10-28, 1399/08/07
Registration timing: registered_while_recruiting

Last update: 2020-10-28, 1399/08/07
Update count: 0
Registration date
2020-10-28, 1399/08/07
Registrant information
Name
Mahta Fazlyab
Name of organization / entity
Islamic Azad University, Dental Branch, Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
mfazlyab@dentiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-16, 1399/05/26
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low level laser therapy with 980 nm diode on post endodontic pain after single-visit treatment of necrotic mandibular molars with periapical lesion; A randomized clinical trial
Public title
Low level laser therapy and post endodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in need for root canal treatment on mandibular molars Mandibular molars with pulp necrosis diagnosed with vitality tests Mandibular molars with periapical lesions scoring 2 or 3 in accordance with the periapical index classification introduced by Ørstavik et al No pain with pulpal origin Pain on percussion with VAS > 56 Patients in good health and systemic condition determined by health history and verbal questioning
Exclusion criteria:
Periodontal probing depth greater than 3 mm Swelling or presence of sinus tract Patients taking analgesia 12 hours prior to intervention Teeth with open apices (immature or inflammatory root resorption) Teeth diagnosed to be non-restorable after the endodontic treatment in primary evaluations
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are placed in a randomized 4-block by the method of Balanced block. The randomization process is performed by an individual other than the investigator, and the information about the sample intervention is stored in sealed envelopes in order to randomize in excel software. The envelopes contain 18 items for the case group and 18 for the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient is not aware of the research treatment group allocation and process. Care provider (endodontist) and investigator (dental student) are aware of the research treatment group allocation and process. Outcome assessor, data analyser and data safety and monitoring board are not aware of the research treatment group allocation and process.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Dentistry, Islamic Azad University
Street address
No. 9, Faculty of Dentistry Islamic Azad University, 9th Neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-09-27, 1399/07/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.180

Health conditions studied

1

Description of health condition studied
Post treatment pain
ICD-10 code
K04.1
ICD-10 code description
Necrosis of pulp, Pulpal gangrene

Primary outcomes

1

Description
post endodontic treatment pain
Timepoint
4, 8, 12, 24, 48, 72 hours and day 7 after endodontic treatment and laser therapy
Method of measurement
VAS ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 980 nm low level laser
Category
Prevention

2

Description
Control group: plasbo laser
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of endodontics, Faculty of dentistry, Tehran medical sciences, Islamic Azad University
Full name of responsible person
Dr Mahta Fazlyab
Street address
No.9, Neyetan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.mfazlyab@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Arash Azizi
Street address
No.9, 9th Neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.mfazlyab@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None applicable
Proportion provided by this source
100
Public or private sector
Private
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
Dr Mahta Fazlyab
Position
Assistant Professor, Endodontics department, Faculty of Dentistry of Islamic Azad University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.mfazlyab@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mahta Fazlyab
Position
Assistant Professor of Endodontics department, Faculty of Dentistry of Islamic Azad University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.mfazlyab@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mahta Fazlyab
Position
Assistant Professor of Endodontics department, Faculty of Dentistry of Islamic Azad University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.mfazlyab@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Undecided - It is not yet known if there will be 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
Title and more details about the data/document
A part of the information, such as information on the main outcome, can be shared
When the data will become available and for how long
The start of the access period will be 6 to 12 months after the results are released
To whom data/document is available
Data will only be available to researchers working in academic institutions
Under which criteria data/document could be used
Data will be available for dental research centers, universities and public and private health centers. All clinicians using laser to reduce pain after endodontic treatment are allowed to use the documentation. Dr. Mahta Fazlyab dr.mfazlyab@gmail.com +982122564571 No. 9, Faculty of Dentistry Islamic Azad University, 9th Neyestan Ave, Pasdaran Ave.
From where data/document is obtainable
Applicants can contact the person responsible for the article to receive the information. Dr.Mahta Fazlyab dr.mfazlyab@yahoo.com Faculty of dentistry of Islamic Azad university +982122564571 No. 9, Faculty of Dentistry Islamic Azad University, 9th Neyestan Ave, Pasdaran Ave.
What processes are involved for a request to access data/document
Demand by email to the person responsible for the article Dr.Mahta Fazlyab dr.mfazlyab@yahoo.com
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