Dimensional changes in free gingival grafts: scalpel versus Er:YAG laser
Design
RCT-split mouth -double blinded
Settings and conduct
Tehran university of medical sciences faculty of dentistry
Participants/Inclusion and exclusion criteria
Age older than 18 years requires increased attached gingiva width in the mandibular premolar area(Keratinized gingiva less than 2mm or attached gingiva less than 1mm)
Patients' health in terms of systemic and periodontal conditions (probe depth less than 3 mm or BOP Grade 1 or less)
good plaque control (plaque index less than 20%)
Ability to adapt the patient to the study-related processes
1- heavy smoker (those who smokes more than 10 cigarettes a day)
Having a systemic problem that has a negative effect on wound healing. And taking medications that interfere with surgical repair
pregnant patients
Use of antibiotics over the past 6 months
Intervention groups
Intervention group: In these patients, the receptor bed of graft is prepared bye Er: cr: YSGG laser ( manufactured by the United States Biolase company with 2 watts, 50Hz, 60% water and 30% air). In the second stage, which is similar between the two groups, the free gingival graft is harvested from the palatal area and then sutured with nylon 0-4 thread
Control group: In these patients, the receptor bed of the graft is prepared by the common method, which is the blade (No. 15). In the second stage, which is similar between the two groups, free gingival graft is harvested from the palatal area and is sutured with nylon 0-4 thread
Main outcome variables
Graft size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170916036203N3
Registration date:2018-05-04, 1397/02/14
Registration timing:retrospective
Last update:2018-05-04, 1397/02/14
Update count:0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Hoori Asl Roosta
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8849 2345
Email address
h-aslroosta@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dimensional changes in free gingival grafts: scalpel versus Er:YAG laser--an rct study
Public title
dimensional change in gingival graft ,scalpel versus graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years requires increased attached gingiva width in the mandibular premolar area(Keratinized gingiva less than 2mm or attached gingiva less than 1mm)
Patients' health in terms of systemic and periodontal conditions (probe depth less than 3 mm or BOP Grade 1 or less)
good plaque control (plaque index less than 20%)
Ability to adapt the patient to the study-related processes
Exclusion criteria:
1- heavy smoker (those who smokes more than 10 cigarettes a day)
Having a systemic problem that has a negative effect on wound healing. And taking medications that interfere with surgical repair
pregnant patients
Use of antibiotics over the past 6 months
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
The sample consists of 10 patients as test and control(split mouth)
Randomization (investigator's opinion)
Randomized
Randomization description
simple individual randomization by sealed envelops
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participant,and data collectors are blind to the study. on the day of surgery the patients will receive the laser light on both side ,but on control side without energy and on the test site the patients will receive energy.on the fallow up visits a person that is blind to the study will record the data
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dentistry Faculty of Tehran University of Medical Sciences
Street address
Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1439955991
Approval date
2017-10-02, 1396/07/10
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1396.3594
Health conditions studied
1
Description of health condition studied
Dimensional changes in gingival graft after 6 months
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
Description
Dimensional changes of free gingival grafts in two substrates prepared with Orbium Laser Er: Cr: YSGG and the Scalpel Common Method
Timepoint
1st, 3rd and 6th months after surgery
Method of measurement
Image J software (mm2)
Secondary outcomes
1
Description
Duration of surgery
Timepoint
Surgical day
Method of measurement
Time in minutes
2
Description
pain
Timepoint
The first 10 days after surgery
Method of measurement
Questionaire (VAS)
3
Description
Swelling
Timepoint
The first 10 days after surgery
Method of measurement
questionnaire and patient examination
4
Description
hematoma
Timepoint
the first 10 days after surgery
Method of measurement
questionaire
5
Description
Colour Match (brightness parameters)
Timepoint
6 month after surgery
Method of measurement
adobe photoshop
Intervention groups
1
Description
Intervention group: In these patients, the receptor bed of graft is prepared bye Er: cr: YSGG laser ( manufactured by the United States Biolase company with 2 watts, 50Hz, 60% water and 30% air). In the second stage, which is similar between the two groups, the free gingival graft is harvested from the palatal area and then sutured with nylon 0-4 thread
Category
Treatment - Surgery
2
Description
Control group: In these patients, the receptor bed of the graft is prepared by the common method, which is the blade (No. 15). In the second stage, which is similar between the two groups, free gingival graft is harvested from the palatal area and is sutured with nylon 0-4 thread
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Tehran University of Medical Sciences
Full name of responsible person
Hamed rahimi
Street address
Department of Periodontology, Thired floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8821 3507
Email
hamedr2003@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Alikhasi
Street address
Department of Periodontology, Thired floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8821 3507
Email
malikhasi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Rahimi
Position
post graduate student of periodantics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Periodontology, Third floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8821 3507
Email
hamedr2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afshin Khorsand
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Department of Periodontology, Third floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8821 3507
Email
a_afshin_khorsand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Rahimi
Position
Post graduate student of periodantics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Periodontology, Third floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8821 3507
Email
hamedr2003@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' data will be shared after they are unidentified.
When the data will become available and for how long
Access to data will be available after the publication of the article.
To whom data/document is available
Data will be available to researchers inside and outside the university
Under which criteria data/document could be used
All data and analyzes are available on referral terms
From where data/document is obtainable
To access, please contact Hamed Rahimi at the email address hamedr2003@yahoo.com.
What processes are involved for a request to access data/document
After sending a request by email, within a week, data will be shared