The aim of this study is to determine the effect of low level laser therapy (LLLT) on reducing complications following tooth extraction.
Design
randomized clinical trial
Settings and conduct
Tooth extraction is performed in Department of Oral and Maxillofacial Surgery , and the patients are then referred to Laser Department of Mashhad University of Medical Sciences for laser therapy. The participants are randomly assigned to four groups using a random numbers table.
Laser therapy is contemplated by an experienced operator. To provide double blind design of the study, neither the participants nor the subject who assesses the outcomes are aware of the group assignment.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- undergoing lower molar extraction.
2) age range between 18 and 50 years
3) no history of underlying systemic disorders, smoking, pregnancy or breast feeding in females
Exclusion criteria
1) the occurrence of dry socket (alveolar osteitis) at follow-up appointments
2) the occurrence of trauma during the extraction process e.g. root fracture,
3) patients who had more than one tooth extraction at the same time.
Intervention groups
This randomized clinical trial consists of 40 subjects who undergo lower molar extraction. The patients are randomly assigned to 4 groups. Group 1 is irradiated with a 660 nm laser (200 mW, 30 seconds to each of the lingual, buccal and occlusal surfaces of the socket, 6 J/area). In group 2, an 810 nm laser will be applied similar to group 1. In group 3, a combination of 660 and 810 nm lasers is used. The patients in group 4 serve as placebo. LLLT is performed at 0.5-1 hour after extraction and 2 days later.
Main outcome variables
The participants are asked to record pain degree using a visual analogue scale (VAS) over 7 days. The amount of wound healing is evaluated on the third and seventh days.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091118002736N2
Registration date:2019-09-25, 1398/07/03
Registration timing:registered_while_recruiting
Last update:2019-09-25, 1398/07/03
Update count:0
Registration date
2019-09-25, 1398/07/03
Registrant information
Name
Farzaneh Ahrari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1883 1145
Email address
ahrarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-24, 1398/07/02
Expected recruitment end date
2019-10-24, 1398/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of low level laser irradiation in reducing pain and accelerating socket healing after undisturbed tooth extraction
Public title
The efficacy of LLLT in reducing complications of tooth extraction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
no history of underlying systemic disorders, smoking, pregnancy or breast feeding in females
no active treatment with antibiotics, steroidal and non-steroidal anti-inflammatory drugs
no sign of periodontal problems in the target teeth.
Exclusion criteria:
the occurrence of dry socket (alveolar osteitis) at follow-up appointments
the occurrence of trauma during the extraction process
patients who had more than one tooth extraction at the same time.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
The participants are randomly assigned to four groups using a random numbers table. The details of the allocated groups are recorded on cards contained in sequentially numbered, sealed, and opaque envelopes. These cards are prepared by an independent person who is not involved in the study protocol. Once the patient undergoes tooth extraction and agrees to participate in the trial, the allocation assignment is revealed by opening the envelope by this independent person.
Blinding (investigator's opinion)
Double blinded
Blinding description
To provide double blind design of the study, neither the participants nor the subject who assesses
the outcomes are aware of the group assignment.
Regarding patient, blinding is so that in the probe is entered the mouth in all patients but the patient is not aware of the wavelength and does not know whether the probe is on or off.
Regarding the assessor, the operator who delivers the pain questionnaires to the patient and the specialist who evaluates the degree of healing using photographs are not aware of the group assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The protocol of the present study was submitted to the ethical committee of Mashhad University of Me
Street address
Dental research center, School of Dentistry, Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Approval date
2016-01-13, 1394/10/23
Ethics committee reference number
IR.MUMS.sd.REC.1394.83
Health conditions studied
1
Description of health condition studied
The patients who undergo molar extraction in the lower jaw.
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
Pain degree
Timepoint
at bedtime for 7 days following tooth extraction
Method of measurement
Visual analogue scale (VAS) for pain
2
Description
wound healing score
Timepoint
days 3 and 7 after tooth extraction
Method of measurement
assessing photographs and scoring the degree of socket wound healing using a 10-cm visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : 1- irradiation with a 660 nm laser: the patients in group 1 (low level red laser) received irradiation from an indium-gallium-aluminum-phosphide (InGaAlP) low level laser (Thor DD2 Control Unit, Thor, London, UK). The laser emits a wavelength of 660 nm and operates at the output power of 200 mW at approximately 10 mm distance to the target area. The target areas are the lingual, buccal and occlusal surfaces of the extraction socket. The irradiation is performed for 30 seconds to each target area, delivering 6 J of energy with energy density of 4.21 J/cm2 per area. Laser exposure is performed after 30 to 60 minutes of extraction (day 1) and 2 days later (day 3).
Category
Treatment - Other
2
Description
Intervention group 2: The subjects in group 2 (low level infrared laser) are irradiated with a gallium- aluminum-arsenide (GaAlAs) low power laser (Thor DD2 Control Unit). This laser emits a wavelength of 810 nm at the power of 200 mW. The target areas and the duration of irradiation are similar to that in group 1, but the surface area of the probe is different. Therefore, 6 J of energy is delivered to each surface with energy density of 21.4 J/cm2,.
Category
Treatment - Other
3
Description
Intervention group 3: In group 3 (combination laser therapy), a combination of InGaAlP and GaAlAs diode lasers is used with exposure time of 15 seconds each. The energy delivered to the target area by the red or infrared lasers is 3 J with energy density of 2.1 J/cm2 for red wavelength and 10.7 J/cm2 for infrared wavelength.
Category
Treatment - Other
4
Description
Control group: The patients in group 4 (placebo) are considered as the control in whom the treatment is the same as that in group 1 but with no laser radiation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Majid Eshghpour
Street address
Mashhad Dental School, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9504
Email
Eshghpourm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873477
Phone
+98 51 3841 2081
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
940469
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental research center, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9504
Email
Ahrarif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Department of Laser, School of dentistry, Vakilabad Blvd.
City
mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9504
Email
ahrarif@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental research center, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9504
Email
Ahrarif@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available