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Clinical Trial of Comparison of Er,Cr:YSGG laser and surgical stripping on pain , patients satisfaction and wound healing in patients with gingival physiologic pigmentation

Protocol summary

Summary
There is an increase in tendency of esthetic removal of gingival melanin hyperpigmentation. In this randomized split mouth study we compared the standard method of removal with a blade with two different settings of the Er,Cr:YSGG laser in order to find the best treatment method. in 33 dental arches of 20 patients (13 needed treatment in both arches and 7 only in the maxilla) The three treatment groups were: surgical stripping, removal with laser setting 1 (4.5 w , 50 Hz, H mode, 80% air, 100% water )and laser setting 2 (2.5 w, S mode, 50 Hz, ,40% air, 20% water) Pain, patient satisfaction and wound healing, Treatment time and the amount of bleeding were evaluated. Re-pigmentation was recorded after one month.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016113018493N3
Registration date: 2017-05-27, 1396/03/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-27, 1396/03/06
Registrant information
Name
Leila Gholami
Name of organization / entity
Hamadan University of Medical Sciences, Faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 1949
Email address
l.gholami@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Zahedan University of Medical Sciences
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-09-01, 1394/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of Comparison of Er,Cr:YSGG laser and surgical stripping on pain , patients satisfaction and wound healing in patients with gingival physiologic pigmentation
Public title
the effect of laser on gum color
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: over 18 years of age; non smoker; systemically healthy individual with a healthy periodontal tissues without periodontal pockets; Loe’s Gingival index of 1 or less; Dummet index of 2 or 3; Heidin index of 3 or 4 Exclusion criteria: pregnant or breastfeeding patients; being under orthodontic treatment; plaque index of more than 20%
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The study was randomized by Block design

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Science
Street address
Zahedan University of Medical Science-Dr.Hesabi square Zahedan
City
Zahedan
Postal code
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
IR.Zaums.REC.1394.18.1

Health conditions studied

1

Description of health condition studied
physiologic gingival pigmentation
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Pain
Timepoint
Immediately after treatment, 1 day and 7 days after treatment
Method of measurement
Visual analog scale of 1 to10

2

Description
Gingival wound healing
Timepoint
1 , 3 ,7 and 30 days after treatment
Method of measurement
healing score: : 0= tissue necrosis 1= ulcer formation 2= incomplete epithelialization 3= complete epithelialization

3

Description
Patient satisfaction
Timepoint
1, 7 days after treatment
Method of measurement
questionnaire

Secondary outcomes

1

Description
Treatment Procedure time
Timepoint
during treatment
Method of measurement
stop watch(in seconds)

2

Description
Bleeding during treatment
Timepoint
during treatment
Method of measurement
scale:1: None, 2: Slight, 3: Moderate, 4: Severe

3

Description
Melanin repigmentation
Timepoint
1 month
Method of measurement
Melanin Pigmentation indexes of Dummet 0= No clinical pigmentation (pink-colored gingiva), 1= Mild clinical pigmentation (mild light brown color) , 2= Moderate clinical pigmentation (medium brown or mixed pink and brown color) , 3= Heavy clinical pigmentation (deep brown or bluish black color)and Hedin: 0= No pigmentation, 1= One or two solitary unit(s) of pigmentation in papillary gingiva without the formation of a continuous ribbon between solitary units

Intervention groups

1

Description
Intervention group 1: laser group with 50 Hz, 4.5 Watt, H mode, 100% water, 80% air
Category
Treatment - Devices

2

Description
Intervention group 2: Laser group with 50 Hertz, 2.5 Watt, S mode, 20% water, 40% air
Category
Treatment - Devices

3

Description
control group: Surgical stripping treatment
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan Faculty of Dentistry
Full name of responsible person
Zohreh molaeimanesh
Street address
Mehr street, Faculty of Dentistry
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Dr.Rafigh doost
Street address
Zahedan University of Medical Sciences-Dr.Hesabi square Zahedan
City
Zahedan
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, Zahedan 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
Assistant professor, Hamedan University of medical sciences
Full name of responsible person
Leila Gholami
Position
Assistant Professor \PhD
Other areas of specialty/work
Street address
Department of Periodontology , faculty of dentistry, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 3824 1949
Fax
Email
l.gholami@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Assistant professor, Hamedan University of medical sciences
Full name of responsible person
Leila Gholami
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontology, Faculty of Dentistry, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81382419491949
Fax
Email
l.gholami@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Assistant professor, Hamedan University of Medical Sciences
Full name of responsible person
Leila Gholami
Position
Assistant Professor
Other areas of specialty/work
Street address
City
Hamedan
Postal code
Phone
+98 81 3824 1949
Fax
Email
l.gholami@umsha.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
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