The aim of the present study is to compare two treatment modalities including conventional and Co2 laser methods in treatment of gingival pigmentation
Design
In this clinical trial, fifteen patients with chief complaint of physiologic gingival pigmentation are chosen. Gingival depigmentation is done via conventional method in the right half of maxillary anterior sextant, and CO2 laser in the left half of maxillary anterior sextant in a split-mouth design.
Settings and conduct
Gingival depigmentation is done using conventional and CO2 laser methods in maxillary anterior sextant in one session in a split mouth design at laser department, dental faculty.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Physiologic entity of gingival pigmentation; Medium to severe hyperpigmentation; Good plaque control. Exclusion criteria: Background reasons or environmental factors as etiology of hyperpigmentation such as endocrine disorders or smoking; Pregnancy or breast feeding; Thin biotype of periodontium; Acute gingival or periodontal disease
Intervention groups
Two treatment modalities for gingival depigmentation including conventional method and CO2 laser
Main outcome variables
Area of pigmentation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170601034288N1
Registration date:2017-12-19, 1396/09/28
Registration timing:prospective
Last update:2017-12-19, 1396/09/28
Update count:0
Registration date
2017-12-19, 1396/09/28
Registrant information
Name
Maryam Nourelahi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3334 1449
Email address
m.noorelahi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2017-12-31, 1396/10/10
Expected recruitment end date
2018-12-01, 1397/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Conventional and CO2 laser techniques in treatment of gingival pigmentation in adults
Public title
Comparison of Conventional and Laser techniques in treatment of gingival pigmentation in adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Physiologic entity of gingival pigmentation
Medium to severe hyperpigmentation based on Dimmitt-Gupta index (DOP)
Plaque index less than 20%
Exclusion criteria:
Medical history which affects the process of tissue healing
Background or environmental factors as etiology of hyperpigmentation such as endocrine disorders or smoking
Pregnancy or breast feeding
Thin biotype of periodontium
Acute gingival or periodontal disease
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
Left side of maxillary anterior sextant; right side of maxillary anterior sextant
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd. Amirkabir bridge
City
Semnan
Province
Semnan
Postal code
35198-99951
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.SEMUMS.REC.1396.2
Health conditions studied
1
Description of health condition studied
Gingival pigmentation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Area of pigmentation
Timepoint
Before the procedure, 1 and 6 months after the procedure
Method of measurement
Taking standard photographs and then quantifying area of pigmentation using Gridlines option in Microsoft Paint software
Secondary outcomes
1
Description
Amount of gingival recession
Timepoint
Before the procedure, 1 and 6 months after the procedure
Method of measurement
Distance from gingival margin to Cemento Enamel Junction
Intervention groups
1
Description
Gingival depigmentation using CO2 laser in the left half of maxillary anterior sextant. In this method CO2 laser (6w, 100 palse/s) with fiber optic filaments is used. Contact mode is used in a cervical to apical direction. Care is taken not to harm tooth
Category
Treatment - Surgery
2
Description
Gingival depigmentation using conventional method in the right half of maxillary anterior sextant. In this method epithelial layer in pigmented areas is removed using diamond bur on high-speed dental headpiece under copious irrigation with saline solution
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty, Semnan University of Medical Sciences
Full name of responsible person
Behnaz Roshannia
Street address
Faculty of dentistry, 17-Shahrivar Blvd.
City
Semnan
Province
Semnan
Postal code
35198-35198
Phone
+98 23 3334 1449
Email
behnaz.dent71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidipoor
Street address
Vice chancellor for research, Headquarters of Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3344 1022
Email
rashidy-pour@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Maryam Nourelahi
Position
Assistant professor/MDS
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dِepartment of Periodontology, Dental faculty,17-Shahrivar Blvd., Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3334 1449
Fax
Email
m.noorelahi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Nourelahi
Position
Assistant professor/MDS
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Periodontology, Faculty of dentistry, 17-Shahrivar Blvd.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3334 1449
Fax
Email
m.noorelahi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Nourelahi
Position
Assistant professor/MDS
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Periodontology, Faculty of dentistry, 17-Shahrivar Blvd.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3334 1449
Fax
Email
m.noorelahi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available