evaluation of the effect of 808 and 660 nm diode lasers on the complications of crown lengthening surgery.
Design
The clinical trial has a control group, with parallel groups, simple blind, randomized by assigning a code to each sample.
Settings and conduct
The study is simple blind and patients are not aware of the assignment of the control and intervention group, the research site is School of Dentistry, Isfahan University of Medical Sciences, after clinical crown length surgery, In the intervention group (one side of the midline) diode laser irradiation with wavelength of 660 nm, power 40 mw, continuously, 30 seconds and wavelength 808 nm, power 200 mw, continuously, 25 second after surgery and 3 days later The control side (the other side of the midline) received a placebo laser and Then the healing is evaluated on the third and seventh days and the pain on the day of surgery, 1,3 and 7 days after surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria : patients need surgical crown length and systemically healthy
exclusion criteria: history of periodontal surgery in the past six months,poor hygiene, poor cooperation, smoking and general contraindications to laser therapy
Intervention groups
Intervention Group: Diode laser radiation with a wavelength of 660 nm, power 40mw, continuously, 30 seconds and wavelength 808 nm, power 200 mw, 25 second, after surgery and 3 days later
Control group: placebo laser radiation after surgery and the third day
Main outcome variables
clinical signs of re-epithelialization, clinical signs of inflammation, clinical signs of homeostasis, pain assessment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110109005570N12
Registration date:2021-08-23, 1400/06/01
Registration timing:retrospective
Last update:2021-08-23, 1400/06/01
Update count:1
Registration date
2021-08-23, 1400/06/01
Registrant information
Name
Parichehr Behfarnia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1666 1707
Email address
behfarnia@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Diode Laser of 808 nm and 660 nm in tissue repair and pain due to surgical crown lengthening
Public title
Evaluation of the effect of laser on repair and pain caused by surgical crown lengtheningn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systemically healthy patients
From 25 years to 60 years
Patients who have at least two teeth with the need for surgical crown lengthening in different quadrants of the mouth and not adjacent to each other
Exclusion criteria:
Patients with a history of periodontal surgery in the past six months
Uncontrolled systemic disease
Long-term treatment with antibiotics or steroids
poor hygiene
low cooperation
smoking habit
General contraindications for laser therapy
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Two teeth on either side of the upper or lower jaw that require crown extension surgery
Randomization (investigator's opinion)
Randomized
Randomization description
Clinical examination perform to select individuals with at least 2 teeth with the need for crown lengthening surgery in different quadrants and not in teeth adjacent to each other. Each half of the jaw is as controls of the other half. The selection of intervention and control half jaws will be randomly using a closed envelope. In such a way that on two cards of the same shape "left half jaw intervention" and the other two cards are written "right half-jaw intervention" and are placed inside four envelopes of the same shape. For each patient, one envelope is opened, intervention half jaw and consequently the control half jaw is defined. The card and envelope are returned to the envelope set for the next patient
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, outcome assessor and data analyzer did not know about the assignment of the control and case groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
e thics committee of Isfahan University of Medical Sciences
Street address
خیابان هزار جریب ، دانشکده دندانپزشکی دانشگاه علوم پزشکی اصفهانی
City
isfahan
Province
Isfehan
Postal code
817467346119
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.128
Health conditions studied
1
Description of health condition studied
surgical crown length
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
clinical signs of re-epithelialization
Timepoint
third and seventh days after surgery
Method of measurement
Observational, 0: there is a distance between the gingival margins, 3: the gingival margins are adjacent, 6: the gingival margin has an overlap
2
Description
clinical signs of inflammation
Timepoint
third and seventh days after surgery
Method of measurement
Observational, 0: redness above 50% of the length of the incision or swelling is visible, 1: redness is seen below 50% 2: redness is not seen
3
Description
clinical signs of haemostasis
Timepoint
third and seventh days after surgery
Method of measurement
Observational, 0. : Bleeding is seen, 1: Fibrin is seen, 2: There is no fibrin
Secondary outcomes
1
Description
Pain at the surgical site
Timepoint
Surgery day, first day, third day. Seventh day after surgery
Method of measurement
visual analog scale
Intervention groups
1
Description
After surgical crown lengthening, in case group diode laser with a wavelength of 660 nm, 40 mW power, continuously, 30 seconds and 808nm wavelength, 200mw power, continuously, 25 second laser irradiation is performed on soft tissue after suturing on the outer surface of the flap on the day of surgery and 3 days later. The control group received a placebo laser on the day of surgery and 3 days later
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan School of Dentistry
Full name of responsible person
parichehre behfarnia
Street address
خیابان هزار جریب ، دانشکده دندانپزشکی اصفهان
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
dr.pbehfarnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
parichehr behfarnia
Street address
hezar jreeb,Isfahan School of Dentistry
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Fax
Email
dr.pbehfarnia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib,St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
dr.pbehfarnia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
HezarJarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
dr.pbehfarnia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
dr.pbehfarnia@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
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
healing data on the third and seventh day and patients' pain
When the data will become available and for how long
Whenever necessary
To whom data/document is available
Available to all researchers
Under which criteria data/document could be used
It can be a guide for researchers with similar projects
From where data/document is obtainable
Department of Periodontology, School of Dentistry, University of Isfahan
What processes are involved for a request to access data/document
A request message will be sent as soon as it is received