Protocol summary

Summary
Objective:: The Effect of Low Level Laser on Wound Healing after Gingivectomy Operation. Inclusion criteria: Patients who do Gingivectomy, Patients who have inflammation of the gums is not caused by periodontal disease. Exclusion criteria: patients that received broadcast systemic antibiotics during 6 mount ago, patients that received periodontal treatment during one year ago.population:22 samples obtained from 12 patients who had Gingivectomy. sample size:22 intervention studied: treatment with diod laser, interventional time: Immediately after surgery, 3 days, 5 days, 7 days, 15 days after surgery.Primary outcome: Wound Healing

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016073117143N2
Registration date: 2016-08-09, 1395/05/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-09, 1395/05/19
Registrant information
Name
Ehsan Rafiei
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4066
Email address
e.rafiei@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Isfahan (Khorasgan), Dental School
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Low Level Laser on Wound Healing after Gingivectomy Operation
Public title
The Effect of Low Level Laser on Wound Healing after Gingivectomy Operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: :Patients who do Gingivectomy, Patients who have inflammation of the gums caused by periodontal disease is not patient with particular systemic diseases; patients under treatment with special medication; smokers and patients consume alcohol; patients that received systemic antibiotics during 6 month ago
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Isfahan (Khorasgan), Dental School
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Approval date
2015-10-07, 1394/07/15
Ethics committee reference number
ir.mui.rec.1394.4.107

Health conditions studied

1

Description of health condition studied
Wound healing gums
ICD-10 code
Z01.2
ICD-10 code description
Dental examination

Primary outcomes

1

Description
Wound healing
Timepoint
Immediately after surgery, 3 days, 7 days, 15 days
Method of measurement
Examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: diode lase,660 nm, power density of 120m/w, 4j/cm, 5min
Category
Treatment - Other

2

Description
control:diode lase,660 nm, power density of 120m/w, 4j/cm, 5min
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dept. of Periodontics, Islamic Azad Dental School Khorasgan Branch, Isfahan, Iran
Full name of responsible person
Ehsan Rafiei
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Islamic Azad University Isfahan (Khorasgan)
Full name of responsible person
Dr Vahid Esfahanian
Street address
Islamic Azad University of Isfahan (Khorasgan), Dental School
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Islamic Azad University Isfahan (Khorasgan)
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
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Ehsan Rafiei
Position
phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4066
Fax
Email
e.rafiei@khuisf.ac.ir; dr_ehsan60@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Ehsan Rafiei
Position
phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4066
Fax
Email
e.rafiei@khuisf.ac.ir; dr_ehsan60@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Ehsan Rafiei
Position
phd
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 3535 4066
Fax
Email
e.rafiei@khuisf.ac.ir; dr.ehsan60@yahoo.com
Web page address

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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