The purpose of this study is comparing the removal of Epulis Fissuratum with surgical blade and CO2 laser. 19 patients with symmetric Epulis Fissuratum lesion in the anterior region of the jaws that refer to Periodontology Department of Dentistry Faculty of Hamadan University of Medical Sciences in 2016-2017 will be selected. Randomly one part of the lesions will be removed with surgical blade as control groups and the other part of the lesions will be removed with CO2 laser as test groups. Suturing would be done if needed. Randomization will be done by a flip of a coin. The time of surgical procedure would be measured for both groups. Assessing of wound healing will be done on day 7 and 14 after surgery. Also vestibular depth would be assessed in both groups on day 14.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071124969N2
Registration date:2016-07-17, 1395/04/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-17, 1395/04/27
Registrant information
Name
Sara Torabi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1059
Email address
s.torabi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of wound healing after Epulis Fissuratum surgery with surgical blade and new generation of CO2 laser in patients with bilateral lesion
Public title
Comparison of Epulis Fissuratum surgery with conventional surgery and laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Epulis Fissuratum lesion in the anterior region of jaws
Exclusion criteria: Patients with systemic disease ; Smoking ; Unacceptable oral hygiene ; Radiotherapy/chemotherapy
Age
From 50 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
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 Hamadan University of Medical Sciences
Street address
In Front of Mardom Park, Shahid Fahmide Avenue, Hamadan
City
Hamadan
Postal code
654178-38741
Approval date
2015-12-16, 1394/09/25
Ethics committee reference number
IR.UMSHA.REC.1394.258
Health conditions studied
1
Description of health condition studied
Epulis Fissuratum
ICD-10 code
K06.2
ICD-10 code description
Gingival and edentulous alveolar ridge lesions associated with trauma
Primary outcomes
1
Description
The time of surgery
Timepoint
during surgery
Method of measurement
stopwatch
2
Description
wound healing
Timepoint
on day 7 and 14 after surgery
Method of measurement
according to check list criteria
3
Description
vestibular depth
Timepoint
on day 14 after surgery
Method of measurement
by probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: surgery of Epulis Fissuratum lesion with CO2 laser
(DEKA device) with 50 Hz frequency and 3 millisecond puls duration
Category
Treatment - Surgery
2
Description
Control group: surgery of Epulis Fissuratum lesion with surgical blade number 15
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Hamadan University of Medical Sciences
Full name of responsible person
Sara Torabi
Street address
Dentistry Faculty of Hamadan University of Medical Sciences, In front of Mardom Park, Shahid Fahmide Avenue, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Hamadan University of Medical Sciences
Full name of responsible person
Shahin Kasraei (Research Assistant)
Street address
Dentistry Faculty of Hamadan University of Medical Sciences
City
Hamadan
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, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Sara Torabi
Position
post graduate student
Other areas of specialty/work
Street address
Dentistry Faculty of Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
sara_torabi1987@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Sara Torabi
Position
post gaduate student
Other areas of specialty/work
Street address
Dentistry Faculty of Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
sara_torabi1987@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Sara Torabi
Position
post graduate student
Other areas of specialty/work
Street address
Dentistry Faculty of Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
sara_torabi1987@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)