Protocol summary

Summary
aim: pain reduction is the main porpuse after different surgeries specially implant surgery. the aim of this study is evaluation of pain reduction after low level diod laser therapy after implant surgery. design: clinical trial , double blind, split mouth, control with laser-like device method and material: inclusive factor is all patients who referring to the to the Department of Oral and Maxillofacial Surgery of Implant Researches Center, Islamic Azad University, dental branch, Tehran, Iran, and require at least 2 implant in the same jaw bilaterally . Exclusion criteria involved patients with systemic problems that can affect on implant surgery. after selection 22 patients, they will be divided to 2 groups as control and target. in the target group after implant surgery a single dose of 6-5 j/Implant diode laser with 980 nm wavelength will be applied. In the control group just will be done laser- like application. then pain relief after anesthesia clearing at 24h,48h, 72h and up to complete pain relief will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011932054N1
Registration date: 2017-03-17, 1395/12/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-17, 1395/12/27
Registrant information
Name
Donya Sadat Mahoutchi
Name of organization / entity
Implant Researches Center, Islamic Azad University, Dental Branch, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 5716
Email address
dent2sm@gmail.com
Recruitment status
Recruitment complete
Funding source
individual
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Low Level Laser Therapy (LLLT) for Pain Reduction After Implant Surgery
Public title
Effect of laser therapy on the pain after implant surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusive factor is all patients who referring to the to the Department of Oral and Maxillofacial Surgery of Implant Researches Center,Islamic Azad University, dental branch, Tehran, Iran, and require at least 2 implant in the same jaw bilaterally . Exclusion criteria involved patients with systemic problems that can affect on implant surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
patient and the controller won't know which samples were under laser radiation because in the control group we just will pretend to laser radiation.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Dental Branch
Street address
10th Neyestan st, Pasdaran Avenue
City
Tehran
Postal code
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1395, 20

Health conditions studied

1

Description of health condition studied
pain after dental implant surgery
ICD-10 code
W90
ICD-10 code description
Exposure to other nonionizing radiation

Primary outcomes

1

Description
pain
Timepoint
24h, 48h, 72h, up to complete pain releif
Method of measurement
visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
in the target group after implant surgery a single dose of 6-5 j/Implant diode laser with 980 nm wavelength will be applied. In the control group just will be done laser- like application.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Implant Researches Center, Islamic Azad University, Dental Branch, Tehran, Iran.
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Implant Researches Center
Full name of responsible person
Donya Sadat Mahoutchi
Street address
Implant Researches Center, Islamic Azad University, Dental Branch, 10th Neyestan st, Pasdaran Avenue .
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Implant Researches Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Implant Researches Center
Full name of responsible person
Donya Sadat Mahoutchi
Position
Dentistry Student
Other areas of specialty/work
Street address
Islamic Azad University, Dental Branch, 10th Neyestan st, Pasdaran Avenue, Tehran , Iran
City
Tehran
Postal code
Phone
+98 912 795 1525
Fax
Email
dent2sm@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Associate Professor, Periodontics Department, Islamic Azad University, Dental Branch, Tehran, Iran.
Full name of responsible person
Fatemeh Sarlati
Position
periodontics
Other areas of specialty/work
Street address
Periodontics Department, Islamic Azad University, Dental Branch, 10th Neyestan st, Pasdaran Avenue, Tehran , Iran.
City
Tehran
Postal code
Phone
+98 21 2256 4570
Fax
Email
f_sarlati@dentaliau.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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