A comparative study of the results of conventional surgery and diode laser in maxillary labial frenectomy
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, on 26 patients (13 patients in each group). The rand function of Excel software was used for randomization.
Settings and conduct
The study will be conducted in the periodontics department of Jundishapur University of Ahvaz, without blinding. In the conventional method, individuals will receive 2% lidocaine and 1:80000 epinephrine by infiltration. The Frenum will be clamped with a hemostat, separated from the underlying bone with a No. 15 blade, and stitched with silk suture thread (size 0 to 4). In the diode laser group, the Quicklase 810 980 nm device will be used at 2.5 watts in continuous mode, with anesthesia similar to the first group. The laser fiber will separate the Frenum from the bone, and the area will be cleaned with sterile gauze soaked in saline. Protective glasses will be worn by the patient and operator. Stitches will not be used in the laser group unless bleeding occurs, in which case similar stitches will be applied.
Participants/Inclusion and exclusion criteria
Inclusion criteria: good cooperation; systemic health; good oral hygiene.
Exclusion criteria: diabetes and other uncontrolled systemic diseases; poor cooperation.
Intervention groups
First group: frenectomy will be performed by the conventional method with bistoury. In second group, frenectomy will be performed by QUICKLASE diode laser.
Main outcome variables
The amount of bleeding during surgery and 1 week later; Wound healing 7 day and 1 month after surgery; Pain intensity during surgery, 1 and 7 days after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231009059673N1
Registration date:2024-08-11, 1403/05/21
Registration timing:prospective
Last update:2024-08-11, 1403/05/21
Update count:0
Registration date
2024-08-11, 1403/05/21
Registrant information
Name
Dariush Johari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8426
Email address
dariushjohari6@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-10-20, 1403/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the results of conventional surgery and diode laser in maxillary labial frenectomy
Public title
A comparative study of the results of conventional surgery and diode laser in maxillary labial frenectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction
Papillary or penetrating to papilla types of maxillary labial frenum
Systemic health
Good oral hygiene
Exclusion criteria:
Diabetes and other uncontrolled systemic diseases
Poor cooperation
Poor oral hygiene
Heavy smoker patients
Age
From 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the Permuted Block Randomization method with a block size of 4. The unit of randomization is the individual. The randomization tool is the Rand function in Excel. Random sequences are generated by Excel and recorded on cards. The cards are placed in opaque envelopes, sealed, and numbered sequentially. During participant enrollment, the envelopes are opened in order, revealing the assigned group for each individual. This method ensures that none of the individuals involved in the study know the assigned group until the moment of allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jundi shapour university of medical science
Street address
Ahvaz, Golestant, Ahvaz Jundishapur University of Medical Sciences, Vice President of Research and Technology
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
IR.AJUMS.REC.1402.267
Health conditions studied
1
Description of health condition studied
1- papillary type of maxillary labial frenum 2- penetrating to papilla type of maxillary labial frenum
Measurement of the height and width of the wound area after frenectomy (mm).
6
Description
Wound healing
Timepoint
One week after surgery; One month after surgery.
Method of measurement
Landry Index
7
Description
Pain intensity during surgery
Timepoint
One day after surgery; 1 week after surgery.
Method of measurement
VAS
Intervention groups
1
Description
first intervention group: conventional surgery. In the conventional method, individuals will receive 2% lidocaine and 1:80000 epinephrine by infiltration. The Frenum will be clamped with a hemostat, separated from the underlying bone with a No. 15 blade, and stitched with silk suture thread (size 0 to 4).
Category
Treatment - Surgery
2
Description
second intervention group: diode laser. In the diode laser group, the Quicklase 810 980 nm device will be used at 2.5 watts in continuous mode, with anesthesia similar to the first group. The laser fiber will separate the Frenum from the bone, and the area will be cleaned with sterile gauze soaked in saline. Protective glasses will be worn by the patient and operator. Stitches will not be used in the laser group unless bleeding occurs, in which case similar stitches will be applied.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialist Department of Periodontics, Ahvaz School of Dentistry
Full name of responsible person
Dariush johari
Street address
Ahvaz, Golestan st, Farvardin St., Faculty of Dentistry, Department of Periodontics
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 917 595 8977
Email
Dariushjohari6@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hojjatallah yousefimanesh
Street address
Ahvaz, Golestan st, Farvardin St., Faculty of Dentistry, Department of Periodontics
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8426
Email
hojjatyoosefi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dariush Johari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ahvaz , golestan, farvardin st , faculty of dentistry
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8426
Fax
Email
Dariushjohari6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dariush Johari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ahvaz , golestan, farvardin st , faculty of dentistry
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8426
Fax
Email
Dariushjohari6@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dariush Johari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ahvaz , golestan, farvardin st , faculty of dentistry
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8426
Fax
Email
Dariushjohari6@gmail.com
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