Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001013550
Ethics application status
Approved
Date submitted
18/07/2015
Date registered
29/09/2015
Date last updated
2/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low Level Laser Therapy in Postsurgical Treatment of Grafted Sockets
Scientific title
Histological Evaluation of the Efficiency of Low Level Laser Therapy on Bone Regeneration in Grafted Tooth Sockets
Secondary ID [1] 287191 0
nil
Universal Trial Number (UTN)
U1111-1172-3344
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tooth extraction 295636 0
Socket graft healing 295637 0
Condition category
Condition code
Oral and Gastrointestinal 295917 295917 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autostatic laser device which patient self-administers at home, pointing at site of grafted socket, starting in day 14 after surgery
Low level laser therapy on the site of grafted sockets; 810nm, 20mW/square cm, 20 min per day, 21 consecutive days
Laser device composed of a comfortable flexible headset, lightweight, low profile, with a soft nose and earpice for individual comfort profile and array positioning to fit range of patients; and a handsfree operation controller. On this controller the doctor sets treatment protocol and the controller counts down time and treatment sessions for patients awareness
Intervention code [1] 292357 0
Treatment: Devices
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 295592 0
x-ray evaluation of bone density of grafted tooth sockets
Timepoint [1] 295592 0
baseline, 60 days, 90 days & 120 days post-surgery
Secondary outcome [1] 315931 0
Histological evaluation of biopsies taken from grafted sockets by the time of implant placement: level of bone regeneration
Timepoint [1] 315931 0
60 days, 90 days & 120 days post-surgery
Secondary outcome [2] 316295 0
time between extraction/socket graft and implant placement
Timepoint [2] 316295 0
60 days, 90 days & 120 days post-surgery; from time of extraction/socket graft to time of implant placement

Eligibility
Key inclusion criteria
systemically healthy subjects, no chronic treatment for any systemic disease, no active infection present at the time of extraction, 5 wall-extraction/ wall defects, undergoing tooth extract surgery in which sockets grafted with bone graft material and covered with resorbable collagen dressing
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
periapical lesions
immediate post-surgical complications such as loose membrane or loose bone graft material

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/06/2014
Actual
21/07/2014
Date of last participant enrolment
Anticipated
Actual
14/01/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
46
Recruitment outside Australia
Country [1] 7036 0
Romania
State/province [1] 7036 0
Mures

Funding & Sponsors
Funding source category [1] 291669 0
University
Name [1] 291669 0
University of Medicine and Pharmacy Tirgu-Mures
Country [1] 291669 0
Romania
Primary sponsor type
Individual
Name
Adriana Monea
Address
Faculty of Dental Medicine
38 Gh.Marinescu Street
post code 540139
Tirgu-Mures
Country
Romania
Secondary sponsor category [1] 290344 0
None
Name [1] 290344 0
Address [1] 290344 0
Country [1] 290344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293199 0
Ethical Commitee Of University of Medicine and Pharmacy Tirgu-Mures
Ethics committee address [1] 293199 0
Ethics committee country [1] 293199 0
Romania
Date submitted for ethics approval [1] 293199 0
Approval date [1] 293199 0
29/05/2014
Ethics approval number [1] 293199 0

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

Contacts
Principal investigator
Name 58874 0
Dr Adriana Monea
Address 58874 0
University of Medicine and Pharmacy Tirgu-Mures
38 Gh.Marinescu Street
post code 540139
Tirgu-Mures
Country 58874 0
Romania
Phone 58874 0
+40746877181
Fax 58874 0
Email 58874 0
[email protected]
Contact person for public queries
Name 58875 0
Gabriela Beresescu
Address 58875 0
University of Medicine and Pharmacy Tirgu-Mures
38 Gh.Marinescu Street
post code 540139
Tirgu-Mures
Country 58875 0
Romania
Phone 58875 0
+40745134184
Fax 58875 0
Email 58875 0
[email protected]
Contact person for scientific queries
Name 58876 0
Adriana Monea
Address 58876 0
University of Medicine and Pharmacy Tirgu-Mures
38 Gh.Marinescu Street
post code 540139
Tirgu-Mures
Country 58876 0
Romania
Phone 58876 0
+40746877181
Fax 58876 0
Email 58876 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.