Objective: This randomized double-blind comparative study was undertaken to assess the efficacy of low power laser therapy in the healing of post-operative soft tissue wound and reduction of pain in patients who had been received implants. This study included 21 patients of both sexes and according to the inclusion and exclusion criteria were selected from patients whom had been received implants bilaterally in posterior sites of their jaws. Each side of every Patient's was randomly allocated to one of two groups according split mouth model: LLLT, or placebo.
Subsequently to suturing, Sides in LLLT group were treated with 808nm and 660nm laser irradiation, intraorally 1mm from the target tissue 200s for 660nm and 20s for 808nm to 3 aspects, buccal, lingual and occlusal, every 48hs until 12th day.
In placebo sides the handpiece was put intra orally but laser was not activated. Wound healing was evaluated on third, seventh and fourteenth post-operative day and pain reduction evaluated on 12th ,24th ,48th and 72 th hour after surgery by means of visual analogue scale (Vas).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061322699N1
Registration date:2017-03-17, 1395/12/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-17, 1395/12/27
Registrant information
Name
Reza Birang
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5525
Email address
birang@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Dean for research, Faculty of Dentistry, Isfahan university of Medical Sciences
Expected recruitment start date
2017-02-20, 1395/12/02
Expected recruitment end date
2017-05-23, 1396/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low power laser (LPL) on soft tissue wound healing and pain reduction after dental implant surgery
Public title
Effect of low power laser (LPL) on soft tissue wound healing and pain reduction after dental implant surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients were registered at the implant department of faculty of dentistry of Isfahan University of medical sciences, possessed of unilaterally posterior edentulous ridges, good bone quality, healthy systemic, not using corticosteroids and bisphosphonate, without sever anxiety and dentistry phobia, age at least 18, without mental disability
Exclusion criteria: Low compliant patients, not attending at the expected time of measurement, smoking, any contraindication of laser therapy, pregnancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Isfahan University Of Medical Sciences
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences, Department of Dental Implants
City
Isfahan
Postal code
8174673461
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.MUI.REC.1395.3.842
Health conditions studied
1
Description of health condition studied
Gingival wound healing
ICD-10 code
Z01.2
ICD-10 code description
Dental examination
Primary outcomes
1
Description
Wound healing
Timepoint
The third, seventh and fourteenth day after surgery
Method of measurement
Direct observation and comparison to standard images
Secondary outcomes
1
Description
pain
Timepoint
12th, 24 th, 48 th and 72 th hour after surgery
Method of measurement
visual analogue scale (Vas)
Intervention groups
1
Description
Intervention Group: Sides in LLLT group were treated with 808nm and 660nm laser irradiations, intraorally 1mm from the target tissue 200s for 660nm and 20s for 808nm to 3 aspects, buccal, lingual and occlusal, every 48hs until 12th day.
Category
Other
2
Description
Control group: Sides in placebo sides the hand piece was put intraorally 1mm from the target tissue 200s for 660nm and 20s for 808nm to 3 aspects, buccal, lingual and occlusal, every 48hs until 12th day. But laser was not activated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Isfahan University of Medical sciences
Full name of responsible person
Soheil Noohi
Street address
Hezarjarib St.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy Dean of research, Faculty of dentistry, Isfan University of Medical Sciences
Full name of responsible person
Dr Reza Birang
Street address
Hezarjarib St, Faculty of Dentistry
City
Isfahan
Grant name
تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Dean of research, Faculty of dentistry, Isfan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Soheil Noohi
Position
Priodotics Postgraduate student
Other areas of specialty/work
Street address
Hezarjarib St,Isfahan University of Medical Sciences
City
Ifahan
Postal code
8174673461
Phone
+98 31 1666 1707
Fax
Email
birang@dnt.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Isfashan Univesity of Medical Sciences
Full name of responsible person
Reza Birang
Position
Professor of Periodontics
Other areas of specialty/work
Street address
Hezarjarib St,Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1666 1707
Fax
Email
birang@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry,Isfahan University of Medical Sciences
Full name of responsible person
Soheil Noohi
Position
Periodontics Postgraduate Student
Other areas of specialty/work
Street address
Hezarjarib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
00
Fax
Email
birang@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)