comparison the effect of 980-810 nm Diode Low Level Laser Therapy(LLLT) and contol group on post operative pain of patients who need crown lengthening surgery.
Evaluating the effect of 980-810 nano meter low level diode laser on post-operative pain of crown lengthening surgery.
Design
The clinical trial has a control group with parallel groups, one side blind and randomized based on the dice roll. For this study, 26 patients are selected. Phase one clinical trial
Settings and conduct
The surgical procedure in the peridontics ward of Ahwaz Dental School will perform blindly. At the end of crown crown lengthening surgery, in the test group low-level laser therapy will performed for 100 seconds on buccal and palatal flap surfaces from a distance of 3 mm Is used. Finally, flap edges are sutured.
In the control group, the laser is used in off mode.
The amount of pain is measured by two methods: the number of capsules that the patient consumes and the visual analogue scale (100 mm horizontal line that shows painless on the left and unbearable pain on the right, and the patient marks the amount of pain on it. And its amount is measured by a ruler) A form is given to the patients and in that form, after registering the surgical area, the patients record the intensity of pain and the number of analgesic capsules from the day of surgery for 7 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients require bilateral maxillary premolars crown lengthening surgery.
Patients with no previous medical or surgical history and a report of systemic disease.
Exclusion criteria: smokers, patients with a history of long-term use of antibiotics and corticosteroids, pregnant women.
Intervention groups
Test group: The group treated with low level laser after crown lengthening
surgery.
control group: The group treated with turned off low level laser after crown lengthening surgery .
Main outcome variables
Visual analog scale, number of analgesics used, treatment group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201102049237N1
Registration date:2020-12-01, 1399/09/11
Registration timing:registered_while_recruiting
Last update:2020-12-01, 1399/09/11
Update count:0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Ali Yazdanpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 8059
Email address
aliyz.00071@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effect of 980-810 nm Diode Low Level Laser Therapy(LLLT) and contol group on post operative pain of patients who need crown lengthening surgery.
Public title
Evaluating the effect of 980-810 nm Diode Low Level Laser Therapy(LLLT) on post operative pain of crown lengthening surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
systematically healthy patients and without any medical history
bilateral teeth need crown lengthening surgery
Exclusion criteria:
smoking patients
patients who use antibiotics and cortico steroids for the long time
peregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
46
More than 1 sample in each individual
Number of samples in each individual:
2
One side of mouth is use for the test group and other side for the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the dice roll, one side of the jaw will select for laser treatment and the other side will select as the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both the operator and the patient wear goggles and apply a low-power laser treatment area for 100 seconds on the buccal and lingual / palatal flap surfaces from a distance of 3 mm. In the control group, the laser is used in the same way, but in off mode.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
golestan, esfand street
City
ahvaz
Province
Khouzestan
Postal code
6135715775
Approval date
2020-10-31, 1399/08/10
Ethics committee reference number
IR.AJUMS.REC.1399.632
Health conditions studied
1
Description of health condition studied
low level laser therapy
ICD-10 code
Z98.818
ICD-10 code description
Other dental procedure status
Primary outcomes
1
Description
visual analog scale (VAS)of pain
Timepoint
Day 1 to 7 after surgery.
Method of measurement
Visual Analogue Scale Questionnaire to assess pain in days 1 to 7 after surgery
2
Description
Number of analgesic drugs consumption per day
Timepoint
day 1 to 7 after surgery.
Method of measurement
Questionnaire on the number of analgesics used in days 1 to 7 after surgery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:treated by low level laser therapy. Both the operator and the patient wear goggles, and in the treatment area, a low-;level 980 and 810 nm quick lase laser with a power of 0.5 watts by continuous whitening handpiece for 100 seconds on the buccal and lingual / palatal flap surfaces from a distance 3 mm is used. Finally, the flap edges are surgically returned to the teeth and bones and sutured with simple or sling sutures with 0-4 silk thread.
Category
Treatment - Surgery
2
Description
Control group: low level laser therapy in off mode. Both the operator and the patient wear goggles, and in the low-power laser treatment area of 980 and 810 nm, the quick lase is applied in off mode for 100 seconds on the buccal and lingual / palatal flap surfaces from a distance of 3 mm. Finally, the flap edges are surgically returned to the teeth and bones and sutured with simple or sling sutures with 0-4 silk thread.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapour University of medical and science ,school of dentistry
Full name of responsible person
Ali Yazdanpanah
Street address
golestan, esfand street, school of dentistry
City
ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
aliyz.00071@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehdi Ahmadimoghadam
Street address
golestan, esfand street, ahvaz jundishapur university of medical and sciences
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Faculty members grant.
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
Dr Azarnoosh Ariankia
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
golestan,esfand street, school of dentistry
City
ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
golpasand-l@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Leila Golpasandhagh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
periodontics
Street address
golestan, esfand street,school of dentistry
City
ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
golpasand-l@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Yazdanpanah
Position
Post graduated student of periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ahvaz jundishapour university of medical and sciences,school of dentistry, department of periodontics
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3336 8059
Fax
Email
aliyz.00071@gmail.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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
visual analog scale
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
dr ali yazdanpanah 00989177043707
What processes are involved for a request to access data/document