The Goal of this study is comparison of treatment outcomes of Diode 808 nm and Er,Cr:YSGG laser on physiologic gingival pigmentation. Study design is interventional (Randomized clinical trial). The study population are patients with chief complaint of gingival pigmentation that present in oral medicine clinic of Shahid Beheshti University of medical sciences Dental School.
Inclusion criteria: Having physiologic gingival melanin pigmentation ; Coordination of gingival pigmentation pattern in terms of intensity and extension of gingival color in left and right ; Voluntary participation in study
Exclusion criteria: History of Diabetes or autoimmune disease ; Under treatment with drugs that influence on gingival color ; Pregnant or breast-feeding women ; Evidence about relation of pigmentation with malignancies ; History of previous treatment of gingival pigmentation ; Smoking ; Periodontal disease ; Uncoordination of gingival pigmentation pattern terms of intensity and extension of gingival color in left and right side.
Sample size is 14 patient. Mouth divided to two parts (left and right) from midline to premolars. Randomly use in a half Er,Cr:YSGG laser and in other half Diode(808nm) laser . Er,Cr:YSGG laser in three session and Diode(808nm) laser in two session ablated. Treatment outcomes followed to 1,3 and 6 months . primary outcome is reduction of extension and intensity color of gingival pigmentation.
General information
Acronym
Gingival Melanin Depigmentation - GMD
IRCT registration information
IRCT registration number:IRCT2015121925610N1
Registration date:2016-04-13, 1395/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-13, 1395/01/25
Registrant information
Name
Somayeh Rahmani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5351
Email address
s_rahmani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research assistant,Dentistry School,Shahid Beheshti University of Medical Scienses
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment outcomes of Diode 808 nm and Er,Cr:YSGG laser on physiologic gingival pigmentation
Public title
effect of Diode and Erbium laser on dark gingival color
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having physiologic gingival melanin pigmentation;Coordination of gingival pigmentation pattern in left and right side , pigmentation intensity in range of moderate to severe and maximum one score difference in extension of pigmentation; Voluntary participation in study
Exclusion criteria:
History of Diabetes or autoimmune disease;Under treatment with drugs that influence on gingival color; Pregnant or breast-feeding women;Evidence about relation of pigmentation with malignancies;History of previous treatment of gingival pigmentation; Smoking;Periodontal disease;Uncoordination of gingival pigmentation pattern in left and right side
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
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
Shahid Beheshti University Of Medical Sciences - Dentistry School
Street address
Dentistry School - Daneshjoo Boulevard - Shahid Chamran High way - Tehran
City
Tehran
Postal code
1983963113
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.177
Health conditions studied
1
Description of health condition studied
Physiologic Gingival Melanin Hyperpigmentation
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation
Primary outcomes
1
Description
Intensity of pigmentation
Timepoint
Before intervention - 1 months after intervention - 3 months after intervention - 6 months after intervention
Method of measurement
Dummett–Gupta Oral Pigmentation Index (DOPI; Dummett 1971) : 1. No clinical pigmentation (pink gingiva) 2. Mild clinical pigmentation (mild light brown color) 3. Moderate clinical pigmentation (medium brown or mixed pink and brown) 4. Heavy clinical pigmentation (deep brown or bluish black)
2
Description
Extension of Pigmentation
Timepoint
Before intervention - 1 months after intervention - 3 months after intervention - 6 months after intervention
Method of measurement
– Hedin melanin index scored as follows: 0- No pigmentation 1- One or two solitary units of pigmentation in the papillary gingiva 2- >3 units of pigmentation in the papillary gingiva without formation of a continuous ribbon 3- One short continuous ribbons of pigmentation 4- One c ontinuous ribbon including the entire area between the canines
Secondary outcomes
1
Description
Pain
Timepoint
During first 24 hours after intervention
Method of measurement
Question: Visual Analogue Scale Score 0 = no pain Score1 = 1 to 30 mm = slight pain Score2= 31 to 60 mm = moderate pain Score3= 61 to 100 mm= sever pain
2
Description
Bleeding
Timepoint
During intervention
Method of measurement
inspection: with bleeding - without bleeding
3
Description
Gingival Recision
Timepoint
1 months after intervention - 3 months after intervention - 6 months after intervention
Method of measurement
inspection: with recision - without recision
4
Description
Gingival Healing
Timepoint
one week after first intervention
Method of measurement
inspection: with healing - without healing
Intervention groups
1
Description
treatment of physiologic gingival pigmentation in one quadrant of one jaw with Diode laser 808nm - 1 watt - CW
Category
Treatment - Devices
2
Description
treatment of physiologic gingival pigmentation in one quadrant of one jaw with Er,Cr:YSGG laser 2780nm- 1.75 watt - 10 % water - 20% Air- 20 HZ- Type MZ8
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti university of medical sciences - Dentistry school - Oral Medicine Departement
Full name of responsible person
Dr Mahin Bakhshi
Street address
oral Medicine Department- Dentistry school - Daneshjoo Boulevard- Evin- shahid chamran highway- Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences - Dentistry school- Research assistant
Full name of responsible person
Mohammad Reza Safavi
Street address
Dentistry school- daneshjoo boulevard - shahid chamran highway- Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences - Dentistry school- Research assistant
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
Shahid Beheshti University of Medical Sciences - Dentistry school
Full name of responsible person
Somayeh Rahmani
Position
Post Graduate dentistry - Oral Medicine student of Shahid Beheshti University of Medical sciences -
Other areas of specialty/work
Street address
Dentistry school - Daneshjoo Boulevard - Shahid Chamran High way- Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Fax
Email
mahinbakhshi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oral Medicine Department , Shahid Beheshti university of Medical Sciences-Dentistry School
Full name of responsible person
Mahin Bakhshi
Position
Oral Medicine Specialist , Associate and faculty member of Shahid Beheshti University of Medical Sci
Other areas of specialty/work
Street address
Dentistry School, Daneshjoo Boulevard, Evin,Shahid Chamran High Way,Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Fax
Email
Mahinbakhshi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences - Dnetistry School
Full name of responsible person
Somayeh Rahmani
Position
Post Gradated Dentistry - Oral Medicine Student
Other areas of specialty/work
Street address
Dentistry School - Daneshjoo Boulevard - Evin - Shahid Chamran High way- Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Fax
+98 22403194
Email
s.rahmani2011@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)