The aim of this study is comparing the effectiveness and recurrence of diode laser 810 nm and cryosurgery for gingival depigmentation. The inclusion criteria is having gingival pigmentation of maxillary incisors and the exclusion criteria are that any diseases or systemic conditions or using any drugs causing gingival pigmentation. This study includes 12 patients aged 15 to 50 years. For further evaluation photographs will be taken before and after treatment within the same position and light. The color analysis will be done using Adobe Photoshop software. Patients will be treated randomized split mouth, with diode laser 810 nm -2w of half of maxillary gingiva and on the opposite side cryosurgery will be done. treatment will be done under topical anesthesia. The laser beam would be activated using the brush technique and in contact mode. Application period differs according to the degree of melanin pigmentation and epithelial thickness of treated area.The cryosurgery will be done one the opposite side with cotton swab. The swab will gently touch and rolled on the area for 10 to 15 seconds until disappear area of gingival pigmentation and looks frosty. All patients will be examined at 1,3 and 6 months after treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011732027N1
Registration date:2017-03-04, 1395/12/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-04, 1395/12/14
Registrant information
Name
Elaheh Esfandiari
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 386 5262
Email address
esfandiari.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Sciences-School Of Dental Medicine
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-02-25, 1395/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of cryosurgery and diode laser 810 nm for gingival depigmentation and recurrence
Public title
comparison of cryosurgery and diode laser for gingival depigmentation and recurrence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion creteria: having physiologic hyperpigmentation in anterior maxillary site
Exclusion creteria: having any disease causing hyper pigmentation; systemic condition causing hyper pigmentation; using drugs causing hyperpigmentation ;smoking
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University Of Medical Sciences
Street address
Ahvaz Jundishapur University Of Medical Sciences-School Of Dental Medicine
City
Ahvaz
Postal code
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.AJUMS.REC.۱۳۹۵.۱۸۶
Health conditions studied
1
Description of health condition studied
gingival Pigmantasion
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
Description
degree of pigmentation
Timepoint
befor treatment and 1, 3 and 6 months after treatment
Method of measurement
photographs has been takene befor and after treatment using Adobe Photoshop software
Secondary outcomes
1
Description
There is no secondary outcome measure in this study, the degree of pigmentation is the only outcome.
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Diode laser 810 nm: the 2w-810nm laser beam will be activated using the brush technique and in contact bmode. Application period differs according to the degree of melanin pigmentation and epithelial thickness of treated area.
Category
Treatment - Surgery
2
Description
Cryosurgery: The cryosurgery will be done with cotton swab. The swab will gently touch and rol on the erea for 10_15 seconds until disappear erea of gingival pigmentation and looks frosty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School Of Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr. Salman Abolfazli
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr. Salman Abolfazli
Street address
Ahvaz Jundishapur University Of Medical Sciences-School Of Dental Medicine
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr Elaheh Esfandiari
Position
resident of periodontics
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences-School Of Dental Medicine
City
Ahvaz
Postal code
Phone
+98 61 3335 3015
Fax
Email
Efandiari.Elaheh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr. Salman Abolfazli
Position
Assistant professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences-School Of Dental Medicine
City
Ahvaz
Postal code
Phone
+98 912 243 3905
Fax
Email
salmanabolfazli@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Elaheh Esfandiari
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Esfandiari.elaheh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)