Influence of postoperative low-level laser therapy using laser diode 940 nm on crestal bone levels around dental implants
Design
Randomization in the present study will be performed in Balance Block Randomization.
Settings and conduct
For each individual on the opposite side of a jaw in a region similar to each side of each side of an implant, and immediately using the mouse split method, the low-power laser of the diode is 940 nm in the power output of 0.5 watts with energy density J / cm2 6 in 6 areas. Around the implants of one side of the jaw receive radiation and does not receive any laser treatment and is considered as an area of control. In order to blind, laser tube is placed on both sides, but only laser laser. Craft's bone surface immediately after the placement of the implants (T0) after 6 weeks (T1) after 6 months (T2) and through parallel-in-oral periapic radiography with parallel technique.
Participants/Inclusion and exclusion criteria
The applicants of implant treatment that two-sided in a jaw in a similar area have lost tooth.
Any systemic illness that contraindicates surgery.
Intervention groups
For each individual on the opposite side of a jaw in a region similar to each side of each side of an implant, and immediately using the mouse split method, the low-power laser of the diode is 940 nm in the power output of 0.5 watts with energy density J / cm2 6 in 6 areas. Around the implants of one side of the jaw receive radiation and does not receive any laser treatment and is considered as an area of control.
Main outcome variables
Cestal bone levels at 4 time 1) immediately after receiving of 940 nm laser (T0) 2) 6 weeks after receiving laser diode 940 nm (T1) 3) 6 months after receiving low-laser diode 940 nm (T2) Using parallel-based digital periametic radiography, measured by parallel technique.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220205053946N1
Registration date:2022-05-09, 1401/02/19
Registration timing:retrospective
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Shabnam Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3433 5369
Email address
shabnamzarei98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of postoperative low-level laser therapy using laser diode 940 nm on crestal bone levels around dental implants
Public title
Influence of postoperative low-level laser therapy on crestal bone levels around dental implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The applicants of implant treatment that two-sided in a jaw in a similar area have lost tooth. tooth extraction at least 6 months before implant surgery; nongrafted implant site; type 2 or 3 bone quality according to the Lekholm and Zarb classification, adequate space with buccolingual width of minimum 6 mm and mesiodistal width of minimum 7 mm; inter-occlusal distance greater than 7 mm.
Exclusion criteria:
Pregnant women. Any mental illness and psychological and behavioral conditions, which is the absolute contraction of implant treatment. Any systemic illness that contraindicates surgery; uncontrolled diabetes mellitus; bisphosphonate therapy; history of radiotherapy in the maxillofacial region within last 12 months; smoking; para-functional habits; poor oral hygiene with full mouth plaque score and full mouth bleeding score ≥25%, periodontally compromised patients with attachment loss ≥3 mm, and/or radiographic bone loss ≥30% of root length in ≥30% of sites and those who refused to return for follow-up were excluded from this study.
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
9
More than 1 sample in each individual
Number of samples in each individual:
2
Right and left in a jaw in a similar area
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
People participating in the study are aware of the laser treatment, but they are not aware of the quadrant that the jaw is radiated.
The oral and maxillofacial surgeon that performs implant treatment is not aware of the quadrant that the jaw is radiated.
People who Evaluate the outcomes (student and the oral and maxillofacial radiologist) are not aware of the quadrant that the jaw is radiated.
People who analyze the data ( Statistical specialist) is not aware of the quadrant that the jaw is radiated.
Only the oral and teeth specialist who performs laser treatment will be aware of the quadrant that the jaw is radiated.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University of Medical Sciences
Measuring crestal bone levels around dental implants by radiography.
Timepoint
Crestal bone level at 4 time 1) immediately after receiving of 940 nm (T0) laser (T0) 2) 6 weeks after receiving laser diode 940 nm (T1) 3) 6 months after receiving low-laser diode 940 nm (T2) Using parallel-based digital periametic radiography, measured by parallel technique.
Method of measurement
Using parallel-based digital periametic radiography, measured by parallel technique.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: An implant is placed on each side on opposite sides of a jaw in the same area, and immediately, using the split-mouth method, with a low-power 940 nm diode laser with a power output of 0.5 watts with 6 j/cm2 energy density in 6 areas around one implant of one side of the jaw (control side), radiation is received. For blinding, the laser tube is placed on both sides, but only on one side of the laser will radiate. Crestal bone level is measured immediately after implant placement (T0), after 6 weeks (T1) and after 6 months (T2) by intraoral digital periapical radiography using a parallel technique. All surgeries are performed by an experienced surgeon with the same technique. All radiographs are performed in a specialized center for oral and maxillofacial radiology by an experienced specialist. All laser treatments are performed by an experienced specialist with the same technique. All patients use the same antibiotics and painkillers.
Category
Treatment - Surgery
2
Description
Control group: The control group is actually the sides of the patients' jaw that is not exposed to the laser beam. Crestal bone level is measured immediately after implant placement (T0), after 6 weeks (T1) and after 6 months (T2) by intraoral digital periapical radiography using a parallel technique. All radiographs are performed in a specialized center for oral and maxillofacial radiology by an experienced specialist. All patients use the same antibiotics and painkillers.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences, Faculty of dentistry
Full name of responsible person
Dr. Ehsan Momeni
Street address
Hepko Ave, Navab ST, Arak, Iran
City
Arak
Province
Markazi
Postal code
3817979438
Phone
+98 86 3369 1355
Fax
Email
daneshkadeha@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/school-dentistry/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
No.2, Hepko Ave, Navab ST, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Ehsan Momeni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No2, Hepko Ave, Navab ST, Arak, Iran
City
Arak
Province
Markazi
Postal code
3817979438
Phone
+98 86 3369 1355
Email
momeni8384@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ehsan Momeni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.2, Hepko Ave, Navab ST, Arak, Iran
City
Arak
Province
Markazi
Postal code
3817979438
Phone
+98 86 3369 1355
Email
momeni8384@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shabnam Zarei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.2, Hepko Ave, Navab ST, Arak, Iran
City
Arak
Province
Markazi
Postal code
3817979438
Phone
+98 86 3369 1355
Email
ShabnamZarei98@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