Radiographic evaluation of interdental bone resorption in immediate implant surgery after LT-IR 660 nanometer low-level laser therapy
Design
A randomized, single-blind, randomized intervention clinical trial on 26 patients. The sampling method is random. The method of randomization is simple and with a table of random numbers.
Settings and conduct
Among the patients referred to the maxillofacial surgery department of Tabriz Dental School who are present for tooth extraction and socket implant placement, participate in the study. Patients are randomly divided into two groups. In the intervention group, immediately after tooth extraction, the implant is placed in the silent dental area according to the standard protocol. Low-power 660 nm diode laser treatment is started immediately after surgery and repeated three times a week for two weeks. The amount of bone at the implant site is measured with the help of periapical intraoral radiography and by computer software immediately after surgery and four months later. In the control group, the laser will not be used. The evaluator is not aware of whether or not to use a laser.
Participants/Inclusion and exclusion criteria
Include criteria: Has enough bone to receive an implant without the need for bone augmentation
Exclude criteria: History of radiotherapy in the craniofacial area in the last 12 months, acute infection of the mouth, untreated or uncontrolled periodontal disease.
Intervention groups
Intervention: Use of low power laser immediately after surgery three times a week for two weeks
Control: No laser receiving
Main outcome variables
The rate of bone resorption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220529055016N1
Registration date:2022-06-01, 1401/03/11
Registration timing:registered_while_recruiting
Last update:2022-06-01, 1401/03/11
Update count:0
Registration date
2022-06-01, 1401/03/11
Registrant information
Name
Orman Onsori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3546 5298
Email address
dr.ormanonsori@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-01, 1401/03/11
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiographic evaluation of interdental bone resorption in immediate implant surgery after LT-IR 660 nanometer low-level laser therapy
Public title
The effect of low power laser on bone density at the implant site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy adults at least 18 years old
Enough bone to receive the implant
No history of tooth extraction in the last 6 months at the selected location
Exclusion criteria:
Pregnancy or breastfeeding
Systemic diseases that affect osteointegration
Anticoagulants
Systemic glucocorticoid therapies
Habit of smoking more than 10 cigarettes a day
The presence of cancer in the mouth
History of seizures
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is random among the people referring to the maxillofacial surgery department of Tabriz Dental School. The randomization method is simple and the unit is individual. Our tool for randomization is the randomized number chart. Furthermore, the allocation of treatment to patients will be done Randomly. To do this, the types of treatment are identified with code A (with the laser) and B (without laser) then will be placed in sealed envelopes and will be stirred. Then they are randomly taken out of the bag and after observing the code, the treatment will be given to the patient. None of the patients will be informed about another patient's treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding should be done in the evaluation phase of bone resorption, which will be done by coding the studied groups. In such a way the evaluator can not diagnose the type of treatment with and without laser before evaluation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Second floor,Central Building No. 2, Tabriz University of Medical Sciences, Golgasht St.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.TBZMED.REC.1401.078
Health conditions studied
1
Description of health condition studied
Dental implant
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants
Primary outcomes
1
Description
The rate of bone resorption
Timepoint
In two times immediately after implant placement and 4 months later
Method of measurement
Periapical intraoral radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Immediately after tooth extraction, the implant is placed in the socket area of the tooth according to the standard protocol. Low-power 660 nm diode laser treatment is started immediately after surgery and repeated three times a week for two weeks. The amount of bone at the implant site is measured by periapical intraoral radiography and by computer software immediately after surgery and four months later.
Category
Treatment - Devices
2
Description
Control group: Immediately after tooth extraction, the implant is placed in the socket area of the tooth according to the standard protocol. Treatment by laser doesn't use. The amount of bone at the implant site is measured by periapical intraoral radiography and by computer software immediately after surgery and four months later.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental School
Full name of responsible person
Dr. Farzad Ismaili
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 657 9590
Email
farzad56@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Kachoei
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 657 9590
Email
farzad56@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Ismaili
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 657 9590
Email
farzad56@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Ismaili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 657 9590
Email
farzad56@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Ismaili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 657 9590
Email
farzad56@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
Not applicable
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