Comparison of Complications and Patients' Satisfaction using Diode laser versus Conventional Technique in Labial Frenectomy
Design
Clinical trials with control group, with parallel groups, randomized, without control with placebo, single center trial. Sample size was 20 patients (2 groups of 10 control and intervention).
Settings and conduct
Faculty of Dentistry, Semnan University of Medical Sciences.
The two study groups will undergo frenectomy surgery.
Intervention group: By laser diode method
Control group: By conventional surgery method
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between 18 to 40 years old are admitted; patients who need labial Frenectomy treatment.
Exclusion criteria: Present of systemic diseases; Present of diabetes; Present of immunodeficiency; Taking aspirin; Present of scleroderma; Addiction; History of delayed wound healing.
Intervention groups
Intervention group:Patients undergo frenectomy according to the protocol using diode laser. First we numb the area. Then hold the top and bottom of the phrenom with the help of two hemostats. With the help of a diode laser, extra tissue is cut. The surgical area will be covered by CO-PAK periodontal dressing.
Control group: Patients underwent frenectomy according to the protocol standard surgical procedure. First we numb the area. Using a coronal razor number 15, extra tissue is cut. Then the incision with a suture 0.3 silk, We stitch.
Main outcome variables
Bleeding severity measure; Satisfaction and pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042679N1
Registration date:2020-02-11, 1398/11/22
Registration timing:registered_while_recruiting
Last update:2020-02-11, 1398/11/22
Update count:0
Registration date
2020-02-11, 1398/11/22
Registrant information
Name
Hanieh Raz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3333 7747
Email address
raz_hanie@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Complications and Patients' Satisfaction using Diode laser versus Conventional Technique in Labial Frenectomy
Public title
Evaluation of ٍDiode Laser in Frenectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 to 40 years old are admitted.
patients who need labial Frenectomy treatment.
Exclusion criteria:
Present of systemic diseases
Present of diabetes
Present of immunodeficiency
Taking aspirin
Present of scleroderma
Addiction
History of delayed wound healing
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:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used.
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
Vice chancellor for research, Semnan University of Medical Sciences building, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3519697344
Approval date
2019-11-02, 1398/08/11
Ethics committee reference number
IR.SEMUMS.REC.1398.189
Health conditions studied
1
Description of health condition studied
Labial frenectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding severity measure
Timepoint
One week and one month after surgery
Method of measurement
The intensity of bleeding will be recorded with a rating of 0 to 5
2
Description
Satisfaction and pain
Timepoint
One week and one month after surgery
Method of measurement
Visual Analogue Scale (VAS) -10cm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Patients undergo frenectomy according to the protocol using diode laser. First we numb the area. Then hold the top and bottom of the phrenom with the help of two hemostats. With the help of a diode laser, extra tissue is cut. The surgical area will be covered by CO-PAK periodontal dressing.
Category
Treatment - Surgery
2
Description
Control group: Patients underwent frenectomy according to the protocol standard surgical procedure. First we numb the area. Using a coronal razor number 15, extra tissue is cut. Then the incision with a suture 0.3 silk, We stitch.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral, Maxillofacial Dentistry, Faculty of Dentistry, Semnan University of Medical Scie
Full name of responsible person
Hanieh Raz
Street address
Faculty of Dentistry, Semnan University of Medical Sciences, Hefdah Shahrivar St., Saadi Square
City
Semnan
Province
Semnan
Postal code
3519697344
Phone
+98 23 3332 2335
Email
raz_hanie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Vice chancellor for research, Semnan University of Medical Sciences building, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3344 1022
Email
p_kokhayahoo@yahoo.com
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
Hanieh Raz
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Beside Range Tavakol, Mirzaye shirazi Blvd, Mashahir square
City
Semnan
Province
Semnan
Postal code
3519697344
Phone
+98 23 3332 1026
Email
raz_hanie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Jalili Sadrabaad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Oral and Maxillofacial Diseases, 17 Shahrivar Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3518794430
Phone
+98 23 3332 1026
Email
dr.njalili@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Jalili Sadrabaad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Oral and Maxillofacial Diseases, 17 Shahrivar Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3518794430
Phone
+98 23 3332 1026
Email
dr.njalili@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Title and more details about the data/document
Some of the data is shared, such as information about the main outcome
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For re-study or scientific use
From where data/document is obtainable
Hanieh Raz
raz_hanie@yahoo.com
What processes are involved for a request to access data/document
Send an email containing the request for access to the study and the type of study use with the applicant's specification
Check email
Send data