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The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft

Protocol summary

Summary
The main aim of this study is to evaluate the effectiveness of low level laser therapy on pain and healing of palatal donor site following free gingival graft. This is a randomized controlled clinical trial with split mouth design. Sample size is 12 and selection will be done among patients who need free gingival graft surgery in periodontology faculty of Tehran university of medical sciences. Inclusion criteria are healthy patient with no systemic disease and plaque index >=10% with bilateral lack of keratinized tissue. All surgeries are performed by one surgeon with 1 month interval. After suturing laser irradiation done by operator (immediatelty after surgery and 1,2,4,7 days after it). laser parameter are Diode, 66o nanometer, power: 200 mW, Continuous wave, time of irradiation: 32 seconds. Patient visits are: 1, 2, 4, 7, 14, 21, 30 and 45 days after surgery and patient pain (VAS), bleeding (question from patient) and epithelialization (by photography) are evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206121150N5
Registration date: 2012-11-30, 1391/09/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-30, 1391/09/10
Registrant information
Name
Neda Moslemi
Name of organization / entity
Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 3902
Email address
nmoslemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Laser research center, Tehran university of medical sciences
Expected recruitment start date
2012-11-10, 1391/08/20
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft
Public title
Effect of laser in free gingival graft
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: healthy patient with no systemic disease; plaque index >=10%; lack of keratinized tissue around teeth (bilateral). Exclusion criteria: smoking; non-cooperative patients.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 12
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Dentistry,Tehran University of Medical Sciences
Street address
Faculty of Dentistry,Tehran University of Medical Science, Karegar Shomali St, Hakim Hwy
City
Tehran
Postal code
5599114399
Approval date
2012-01-30, 1390/11/10
Ethics committee reference number
91019716886

Health conditions studied

1

Description of health condition studied
free gingival graft
ICD-10 code
K06.0
ICD-10 code description
Gingival recession (generalized) (localized) (postinfective) (post-operative)

Primary outcomes

1

Description
healing of donor site
Timepoint
1,2,4,7,14,21,30,45 days after surgery
Method of measurement
photography

2

Description
epithelialization of donor site
Timepoint
8,14,21 days after surgery
Method of measurement
h2o2 3%

3

Description
pain
Timepoint
1,2,3,4,5,6,7,8 hours and 1,2,3,4,5,6,7,8,14 days after surgery
Method of measurement
VAS and number of talet

Secondary outcomes

1

Description
bleeding
Timepoint
immediately and 1 day after surgery
Method of measurement
questionnaire

Intervention groups

1

Description
laser irradiatin Diode, 66o nanometer, power:200 mW, Continuous wave, time of irradiation:32 seconds
Category
Other

2

Description
turned off laser
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodontology Center, Faculty of Dentistry,Tehran University of Medical Sciences
Full name of responsible person
Neda Moslemi
Street address
Faculty of Dentistry,Tehran University of Medical Science, Karegar Shomali St, Hakim Hwy
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Laser Research Center,Tehran University of Medical Sciences
Full name of responsible person
Nasim Chiniforush
Street address
Faculty of Dentistry,Tehran University of Medical Sciences, Karegar Shomali St, Hakim Hwy
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Laser Research Center,Tehran University of Medical Sciences
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
Faculty of Dentistry,Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Heidari
Position
student of Periodontology
Other areas of specialty/work
Street address
Faculty of Dentistry,Tehran University of Medical Sciences, Karegar Shomali St, Hakim Hwy
City
Tehran
Postal code
5599114399
Phone
+98 21888497390
Fax
Email
heidari_mohadeseh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Dentistry,Tehran University of Medical Sciences
Full name of responsible person
Neda Moslemi
Position
Periodontologist
Other areas of specialty/work
Street address
Faculty of Dentistry,Tehran University of Medical Sciences, Karegar Shomali St, Hakim Hwy
City
Tehran
Postal code
5599114399
Phone
+98 21 8849 7390
Fax
Email
neda_moslemi@yahoo.com
Web page address
heidari_mohadeseh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Dentistry,Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Heidari
Position
student of Periodontology
Other areas of specialty/work
Street address
Faculty of Dentistry,Tehran University of Medical Sciences, Karegar Shomali St, Hakim Hwy
City
Tehran
Postal code
5599114399
Phone
+98 21 8849 7390
Fax
Email
heidari_mohadeseh@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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