This study sought to compare the efficacy of two diode laser irradiation protocols for treatment of gingival pigmentations namely the conventional method and the sieve method.
The study design was non-randomized, single blind, positive control with conventional method, uni center and 2nd phase trial. Inclusion criteria consists of patients with gingival pigmentation who seek treatment. The exclusion criteria include systemic disease and cigarette smoking. Sample size was calculated 15 patients.
Intervention: Diode laser (980 nm wavelength and 2Watt power) was irradiated through a stipple pattern (sieve method) and conventionally (980 nm wavelength and 2Watt power) in the other side of the mouth by brush stroke pattern. Patients were followed at two weeks, one month and three months.
For primary outcome measurement pigmentation levels were determined using Dummett’s oral pigmentation index (DOPI). secondary outcome; pain, was assessed by visual analogue scale (VAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111024988N1
Registration date:2016-03-12, 1394/12/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-12, 1394/12/22
Registrant information
Name
Noushin Janbakhsh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 316 7499
Email address
noushinjanbakhsh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental School of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-04-18, 1394/01/29
Expected recruitment end date
2015-07-20, 1394/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of conventional laser irradiation versus a new method for depigmentation in patients with gingival pigmentation
Public title
efficacy of conventional laser irradiation versus a new method for gingival depigmentation
Purpose
Treatment
Inclusion/Exclusion criteria
1. Physiologic gingival pigmentation both at the right left sides of mandible and maxilla extending to the distal aspect of the canines.
2. Patients’ demand for depigmentation./
1. Systemic conditions, medication intake and pregnancy or nursing
2. Pigmentations linked to malignancy
3. History of previous depigmentation treatments
4. Cigarette smoking.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
dental school, shahid beheshti universtity of medical sciences
Street address
daneshju boulevard, Evin, Tehran
City
Tehran
Postal code
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.108
Health conditions studied
1
Description of health condition studied
gingival hyperpigmentation
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation
Primary outcomes
1
Description
gingival pigmentation intensity
Timepoint
two weeks, one month, 3 months following the end of the treatment
Method of measurement
Dummet's oral pigmentation index
Secondary outcomes
1
Description
pain
Timepoint
first week after surgery
Method of measurement
visual analogue scale
Intervention groups
1
Description
Diode laser (980 nm wavelength and 2Watt power) was irradiated through a stipple pattern (sieve method) and conventionally (980 nm wavelength and 2Watt power) in the other side of the mouth by brush stroke pattern. Patients were followed at two weeks, one month and three months.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, Dental School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Khalilian
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Dental School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Arash Khojasteh
Street address
Daneshjou Boulevard
City
Tehran
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 Dental School, Shahid Beheshti 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
Department of Periodontics, School of Dentistry, Shahid beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Khalilian
Position
Post graduate student
Other areas of specialty/work
Street address
Daneshju boulevard, Evin, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4421 4103
Fax
Email
fatemehkhalilian1987@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Periodontics, School of Dentistry, Shahid beheshti University of Medical Sciences
Full name of responsible person
Noushin Janbakhsh
Position
Post graduate student
Other areas of specialty/work
Street address
Daneshju boulevard, Evin, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4421 4103
Fax
Email
noushinjanbakhsh@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Periodontics, School of Dentistry, Shahid beheshti University of Medical Sciences
Full name of responsible person
Noushin Janbakh
Position
Post graduate student
Other areas of specialty/work
Street address
Daneshju boulevard, Evin, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)