1. Home
  2. Approved trials
  3. » فارسی

Comparison of Recurrent Rate of Gingival Pigmentation after Treatment by Liquid Nitrogen and cryoprob in 18 Months Follow up in people who have anterior physiologic gingival pigmentation

Protocol summary

Summary
Objectives: Various depigmentation techniques have been employed to manage gingival pigmentation. Cryosurgery is one of the simplest, most effective depigmentation methods. Repigmentation may happen after a while. The aim of this clinical trial is to compare the recurrence rate of gingival pigmentation after treatment by cryosurgery with application of liquid nitrogen by Swap and applying cryoprob in 18 months follow up. Design: Interventional,not blinded, Unicenter, no placebo. Population:26 patients without age limitation, no sex limitation Inclusion Criteria: physiologic gingival pigmentation were selected.Setting and conduct: The anterior sextant was divided into 2, left and right segments; each segment was treated randomly by swap technique or cryoprob. Standard photos was taken from the experimental sites, before the treatment and at 2week,1,3,6,9,12,15,18months after the treatment. The photographs were evaluated by using color analyzing systems of RGB and CMYK with photoshop software. Exclusion criteria: Gingival pigmentation of any systemic disease. Sample Size: 52 intervention Intervention: utilization of Cryo probe and Cryo swab Intervention Duration: 18 month Primary Result: Gingival Depigmentation Secondary consequence: Gingival Pigmentation Recurrence

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022512594N1
Registration date: 2013-07-22, 1392/04/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-22, 1392/04/31
Registrant information
Name
Saba Badihi
Name of organization / entity
Dental School, Khorasgan Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 31 1234 5917
Email address
s.badihi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-02-04, 1389/11/15
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Recurrent Rate of Gingival Pigmentation after Treatment by Liquid Nitrogen and cryoprob in 18 Months Follow up in people who have anterior physiologic gingival pigmentation
Public title
Recurrence in Gingival Pigmentation thrapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria physiologic melanin pigmentation of the gingiva Exclusion Criteria Gingival pigmentation of any systemic disease;Pigmentation caused by certain medications such as antimalarial drugs;anti-bacterial drug Smoking; Gingivitis; known hypersensitivity to the liquid nitrogen and N2O.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Khorasgan Branch
Street address
Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavaniyeh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2011-04-23, 1390/02/03
Ethics committee reference number
90021007904

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
Gingiva melanin Pigmentation rate
Timepoint
pretreatment, 2week, 1, 3, 6, 9, 12, 15, 18months after the treatment
Method of measurement
using color analyzing systems of RGB and CMYK with photoshop software

Secondary outcomes

1

Description
Mean of the value of Gingival Pigmentation
Timepoint
pretreatment, 2week, 1, 3, 6, 9, 12, 15, 18 months after the treatment
Method of measurement
color analyzing systems of RGB and CMYK with photoshop software

Intervention groups

1

Description
The anterior sextant of lower jaw was used as a control group (without any intervention).
Category
Treatment - Devices

2

Description
In this clinical trial Two types of cryogen were used: liquid nitrogen and nitrous oxide with No specific concentration or specific dose, that connected to the pigmented gingiva. The anterior sextant of upper jaw was divided into 2, left and right segments; each segment was treated randomly by swab dipped in liquid nitrogen and cryoprob that connected to the nitrous oxide cylinder. Each method was performed only once for each patient , and just for a few seconds.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Periodontology, Dental School, Khorasgan Branch, Islamic Azad University
Full name of responsible person
Saba Badihi
Street address
Dental School, Khorasgan Branch, Islamic Azad University, Arghavaniyeh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Dental School, Khorasgan Branch, Islamic Azad University
Full name of responsible person
Dr Vahid Esfahanian
Street address
Dental School, Khorasgan Branch, Islamic Azad University, Arghavaniyeh Street, Eastern Jey 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, Dental School, Khorasgan Branch, Islamic Azad University
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
Dental School, Khorasgan Branch, Islamic Azad University
Full name of responsible person
Saba Badihi
Position
Dentist, DDs
Other areas of specialty/work
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1234 5917
Fax
Email
s.badihi@khuisf.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Periodontology, Dental School, Khorasgan Branch, Islamic Azad University
Full name of responsible person
Shirin Amini Sedeh
Position
Assistant Professor/ DDs,MS
Other areas of specialty/work
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
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
Dental School, Khorasgan Branch, Islamic Azad University
Full name of responsible person
Saba Badihi
Position
Dentist, DDs
Other areas of specialty/work
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1234 5917
Fax
Email
s.badihi@khuisf.ac.ir
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
Loading...