Aim: Various depigmentation techniques have been employed to manage gingival pigmentation. Cryosurgery is one of the simplest, most effective depigmentation methods. The aim of this clinical trial is to compare the reduction of gingival pigmentation after treatment by cryosurgery with application of liquid nitrogen by Swab and utilizing cryoprob in 6 months follow up. Study Design: Interventional, single blind, unicenter, randomized clinical trial. Population: Sixteen adult patients (16-50) without sex limitation with physiologic gingival pigmentation were selected. The anterior sextant was divided into left and right segments; each segment was treated randomly by open technique using swab or close method by means of cryoprob. Standard photos were taken from the experimental sites, before the treatment and at 2 weeks, 1, 3, 6 months after the treatment. The photographs were evaluated by using color analyzing systems of Red-Green-Black (RGB) and Cyan-Magenta-Yellow-Black (CMYK) with photoshop software by a professional person blind to the selected treatment technique. The intensity of pain during the treatment was compared between two groups by using a questionnaire.
Exclusion criteria: Gingival pigmentation due to any systemic disease. Sample Size: Thirty-two interventions were performed in 16 individuals. Intervention: Utilization of Cryoprob and Cryo swab. Intervention Duration: 6 months. Primary Result: Gingival depigmentation. Secondary consequence: Pain during treatment and recurrence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091012487N3
Registration date:2013-10-22, 1392/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-22, 1392/07/30
Registrant information
Name
Shirin Amini
Name of organization / entity
Khorasgan Branch, Islamic Azad University, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
sh.amini@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-02-04, 1389/11/15
Expected recruitment end date
2011-06-13, 1390/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of gingival depigmentation by open and closed cryosurgery in an Iranian population: A clinical trial
Public title
Comparison of two Cryotherapy techniques in gums color
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Gingival physiologic melanin pigmentation. Exclusion Criteria: Gingival pigmentation due to any systemic diseases, pigmentation caused by certain medications such as antimalarial drugs, anti-bacterial drug, smoking, gingivitis and known hypersensitivity to the liquid nitrogen and N2O.
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Each patient was given a number from 1 to 16. The anterior sextant was divided into left and right segments from mid-line, after isolating of the location by cotton rolls, each segment was treated randomly by either swap technique or cryoprob, based on even or odd number of the patients.
Blindness: All pre and postoperative photographs were traced and measured by another examiner who is expert in using photoshop software and was blind to the utilized technique in each segment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Khorasgan Branch, Islamic Azad University
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran.
City
Isfahan
Postal code
81595158
Approval date
2011-01-23, 1389/11/03
Ethics committee reference number
06807/د/890329
Health conditions studied
1
Description of health condition studied
Gingival Pigmentation
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
Description
Gingival color
Timepoint
Pretreatment, 2weeks,1, 3 and 6 months after the treatment
Method of measurement
using color analyzing systems of RGB and CMYK with photoshop software
Secondary outcomes
1
Description
Recurrence of Pigmentation
Timepoint
2week,1,3,6 months after the treatment
Method of measurement
color analyzing systems of RGB and CMYK with photoshop software
2
Description
Pain
Timepoint
During and post operation
Method of measurement
Visual Analogue Scale by Questionnaire
Intervention groups
1
Description
Case2: Cryoprob model C505T, Danesh Company, Iran. The prob was applied to pigmented areas (4 mm in diameter) for 10-15 second. This procedure was repeated 4 or 5 times for each segment.
Category
Treatment - Devices
2
Description
Case1: Liquid Nitrogen, Iran
Liquid nitrogen100% ,Zeitun Company,Iran, was applied to pigmented areas by a cotton swab (4 mm in diameter) with a forward and backward rolling technique. This procedure was repeated 4 or 5 times for each area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology Department, Dental School, Khorasgan Branch (Isfahan), Islamic Azad University
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of Islamic Azad University Khorasgan Branch
Full name of responsible person
Esfahanian, Vahid
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
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 Khorasgan Branch
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 Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Amini, Shirin
Position
Assistant Professor/ DDS, MSc
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran.
City
Isfahan
Postal code
81595158
Phone
+98 31 1535 4053
Fax
Email
Sh.amini@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Amini, Shirin
Position
Assistant Professor/ DDS, MSc
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Phone
+98 31 1535 4053
Fax
Email
Sh.amini@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Ferdosizadeh, Fatemeh
Position
Dentist, DDs
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran
City
Isfahan
Postal code
81595158
Phone
+98 31 1535 4053
Fax
Email
s.badihi@khuisf.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)