Determining the most effective method of gingival depigmentation in terms of treatment outcome, patient comfort, and patient satisfaction
Design
Randomized clinical trial with single blinded outcome assessment, split mouth design of 16 patients followed for 3 months.
Settings and conduct
The two mentioned techniques were compared in terms of gingival depigmentation, postoperative pain, pigmentation recurrence and patients’ satisfaction. Gingiva of each patient was splitted into two halves and each half randomly received one treatment modality. In this single-blinded study persons examining the treatment results were unaware of the type of treatment modalities each half received. This study was conducted in Isfahan University of Medical Sciences. Patients were followed up in 1st week, 1 & 3 months after operation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 18-60 years with physiological gingival pigmentation.
Exclusion criteria: patients who showed hyperpigmentation due to systemic or genetic disorders or consuming drugs; patients who were smokers patients who had periodontal diseases; pregnant and feeding women.
Intervention groups
Group 1: Maxillary quadrant treated with diode laser. Group 2: Maxillary contrast quadrant treated with CO2 laser.
Comparative study of the effect of two types of diode and CO2 lasers in the treatment of gingival pigmentation (with 3 months follow-up)
Public title
Investigation of the effect of laser on darkening of the gums
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-60 years old
Systemic health
Physiologic gingival pigmentation
Exclusion criteria:
Hyperpigmentation due to systemic or genetic disorders
Consuming drugs cause Hyperpigmantation
Smoking
Patients with periodontal disease
Pregnant And feeding Women
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Maxillary gingiva of each patient was split into right and left halves (Split Mouth technique). One half was treated by diode laser and the other half by CO2 laser. The divided areas were randomly allotted for depigmentation by coin toss
Blinding (investigator's opinion)
Single blinded
Blinding description
Experts reviewing the results of the two interventions are also unaware of the type of intervention done on the patients' gingival sites. In order to achieve the goals of blindness in this study, it needs to be explained that the expert doing the surgical procedure is different from the one evaluating the results of the two surgical procedures and the expert evaluate is completely unaware of the type of surgical method used in the surgical sites and is selected from outside of the surgical team
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-04-03, 1399/01/15
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.010
Health conditions studied
1
Description of health condition studied
Gingival pigmantation
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
Description
Pigmentation area
Timepoint
0, 1 month & 3 months later
Method of measurement
with image J software
2
Description
RGB Index in Gingiva
Timepoint
0,1, 3 months later
Method of measurement
Photoshop software
Secondary outcomes
1
Description
Post operation pain
Timepoint
1 hour, 1 day & 1 week
Method of measurement
Questionnaire(Visual Analog Scale)
2
Description
Patient satisfication
Timepoint
3 months
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: CO2 laser. The segments in this group underwent gingival depigmentation with CO2 laser at Super Dream Pulse and non-contact mode. the operation will be done in one session that takes about an hour.
Category
Treatment - Surgery
2
Description
Intervention group: Diode Laser. The segments in this group underwent gingival depigmentation with diode laser (980 nm) at continuous and contact mode. the operation will be done in one session that takes about an hour.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School Of Dentistry, Isfahan University of Medical science
Full name of responsible person
Samaneh Soltani
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
Sas_851050@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghgoy
Street address
Isfahan University of Medical Sciences, Hezar Jirib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samaneh Soltani
Position
Resident of Periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
Sas_851050@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Reza Birang
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
birang@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samaneh Soltani
Position
Resident of Periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
Sas_851050@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD