Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000181404
Ethics application status
Approved
Date submitted
18/01/2016
Date registered
11/02/2016
Date last updated
11/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of low level laser therapy after extraction of 3rd molar on mouth opening, pain and facial swelling.
Scientific title
Effects of low level laser therapy after extraction of 3rd molar on mouth opening, pain and facial swelling.
Secondary ID [1] 288281 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Swelling after surgery to remove 3rd molar 297238 0
Pain after surgery to remove 3rd molar 297239 0
Mouth opening after surgery to remove 3rd molar' 297240 0
Condition category
Condition code
Oral and Gastrointestinal 297448 297448 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 297775 297775 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgery was performed under local anesthesia with 2 ml of 4% articaine with epinephrine 1:100,000 (Ultracain D-S Forte, Sanofi Aventis, Istanbul, Turkey) in two sessions separated by at least a month. A single maxillofacial surgeon performed all surgical procedures. A random side impacted tooth of the patients was extracted at the first appointment, and an extraoral laser was applied on the area of masseter muscle immediately after the surgical procedure and at the appointment 2 days after the surgical procedure. A gallium–aluminum–arsenide (GaAlAs) diode laser device (CHEESE Dental Laser System, Wuhan GigaaOptronics Technology Company, China) with a continuous wavelength of 810 nm was used, and the laser therapy was applied to treatment group at 300 mW (0.3 W) for a total of 40 second by using a 1×3-cm hand piece. The other side impacted 3rd molar tooth was extracted after 1 month. Ice was applied for the first 48 h for 10 min every hour while awake.
. Then facial swelling was determined with 3dMD face system, pain level was determined visual analog scale and inter incisal opening was measured with caliper.
Intervention code [1] 293575 0
Treatment: Devices
Comparator / control treatment
Patients were advised to apply ice to affected region of the face after surgery. Ice was applied for the first 48 h for 10 min every hour while awake.
Control group
Active

Outcomes
Primary outcome [1] 297005 0
Facial swelling assessed using 3dMD Face (3dMD, Atlanta, GA) Photogrammetric System.
Timepoint [1] 297005 0
0 days pre surgery; 2 days and 7 days post surgery
Primary outcome [2] 297006 0
The pain levels were recorded on the visual analogue scale (VAS) of 10 cm; the scores ranged from 0 (no pain) to 10 (the worst pain possible).
Timepoint [2] 297006 0
2 days and 7 days post surgery
Secondary outcome [1] 320668 0
Mouth opening was assessed by caliper.
Timepoint [1] 320668 0
0 days presurgery; 2 days and 7 days post surgery

Eligibility
Key inclusion criteria
Patients who had bilateral impacted lower 3rd molars
Minimum age
17 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
contraindications of laser therapy
systemic illness
current smoking habit
local infection
acute pericoronitis
breastfeeding
pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
1/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 7506 0
Turkey
State/province [1] 7506 0
Malatya

Funding & Sponsors
Funding source category [1] 292661 0
Self funded/Unfunded
Name [1] 292661 0
Hilal ALAN
Country [1] 292661 0
Turkey
Primary sponsor type
Individual
Name
Hilal ALAN
Address
Inonu University, Dentistry Faculty, Department of Oral and Maxillofacial Surgery
44280 Malatya/Turkey
Country
Turkey
Secondary sponsor category [1] 291379 0
None
Name [1] 291379 0
Address [1] 291379 0
Country [1] 291379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294191 0
MALATYA CLINICAL RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 294191 0
Ethics committee country [1] 294191 0
Turkey
Date submitted for ethics approval [1] 294191 0
11/07/2012
Approval date [1] 294191 0
25/09/2012
Ethics approval number [1] 294191 0
2012/147

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62622 0
Dr Hilal ALAN
Address 62622 0
Inonu University, Dentistry Faculty, Department of Oral and Maxillofacial Surgery
Campus, Elazig Street 44280 Malatya/ TURKEY
Country 62622 0
Turkey
Phone 62622 0
+ 90 422 3411106
Fax 62622 0
+ 90 422 3411107
Email 62622 0
[email protected]
Contact person for public queries
Name 62623 0
Hilal ALAN
Address 62623 0
Inonu University, Dentistry Faculty, Department of Oral and Maxillofacial Surgery
Campus, Elazig Street 44280 Malatya/ TURKEY
Country 62623 0
Turkey
Phone 62623 0
+ 90 422 3411106
Fax 62623 0
+ 90 422 3411107
Email 62623 0
[email protected]
Contact person for scientific queries
Name 62624 0
Hilal ALAN
Address 62624 0
Inonu University, Dentistry Faculty, Department of Oral and Maxillofacial Surgery
Campus, Elazig Street 44280 Malatya/ TURKEY
Country 62624 0
Turkey
Phone 62624 0
+ 90 422 3411106
Fax 62624 0
+ 90 422 3411107
Email 62624 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.