The effect of Low level laser in biomaterial used in maxillary sinus graft (histological and Radiological examination) a randomized controlled clinical trial
The aim of study: Evaluation of Low level laser effect on biomaterial (FDBA+PRF) used in maxillary sinus augmentation.
Study design: This study is designed asa split mouth; it means that in all participants in the study,one side will treated asa control group randomly and opposite side as an intervention group. All patients will undergone bimaxillary sinus lift surgery and in both sides (either control group or intervention groups)will be used FDBA and PRF as biomaterials forSinus floor Augmentation.After completion of the surgery, on the intervention sidewill be used low level laser (LLL) for 30 seconds in the times of immediately after the surgery and third and fifth days after surgery. In this randomized clinical trial will be selected 19 patients of 30-80 year-old that major inclusion criteria is severe atrophy inposteriorof maxillary؛either complete edentulous or bilateral posterior edentulous. The major exclusioncriteria of patients from study are the existence of systemic diseases and pathological lesions in the maxillary sinus. CBCT and Panoramic radiographs will be supplying from all of patientsbefore surgery.
Study Outcomes: After 5 months from the sinus surgery, at first CBCT will be taken for bone density assessment of surgery area (according to Hansfield unit) and then will be taken biopsy from certain areas and samples will be sent to histological laboratoryfor histologic evaluation of percentage of new bone formation and the remaining biomaterials.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012410155N3
Registration date:2016-02-22, 1394/12/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-22, 1394/12/03
Registrant information
Name
Mohammad Taghi Chitsazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
chitsazm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Gingival and Dental Research Center of Tabriz Dentistry Faculty
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Low level laser in biomaterial used in maxillary sinus graft (histological and Radiological examination) a randomized controlled clinical trial
Public title
The effect of Low level laser in biomaterial used in maxillary sinus graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:The existence of bilaterally partial edentulous in maxillary posterior region or complete edentulous in maxilla; Height of the remaining bone between the floor of sinus and alveolar crest be less than 5mm
Exclusion criteria:Smokers; pregnant women ; pathological symptoms or cystic lesions in the sinus ; acute and chronic inflammatory disease of sinus; benign and malignant tumors in sinus ;uncontrolled systemic diseases ; the existence of untreated periodontal disease
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Univrsity of Tabriz Medical Science
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences
City
TABRIZ
Postal code
Approval date
2016-01-20, 1394/10/30
Ethics committee reference number
tbzmed.rec.1394.922
Health conditions studied
1
Description of health condition studied
Resorption of alveolar ridge in the maxillary posterior region
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
The newly formed bone
Timepoint
5 months after grafting
Method of measurement
Histologic examination and measurements through the via software motic images plus v2.0
2
Description
Evaluation of The newly formed bone density
Timepoint
5 months after grafting
Method of measurement
By CBCT and NNT viewer Version21 software
Secondary outcomes
empty
Intervention groups
1
Description
The sinus floor of control group will be augmented with lateral window sinus lift surgical technique by using biomaterials (allograft + PFR)
Category
Treatment - Surgery
2
Description
Intervention group:Surgical technique and biomaterials is similar to the control group, with the difference that immediately after the surgery and the third and fifth days after surgery, low level laser (diode laser "BioLase", 980nm, 0.5 W) will be lighted on surgery area.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Dr Chitsazi
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gingival and Dental Research Center of Tabriz dentistry Faculty
Full name of responsible person
Dr Shahriar Shahi
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences TABRIZ
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gingival and Dental Research Center of Tabriz dentistry Faculty
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
Full name of responsible person
Dr Alihossein Dehghani
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Faculty of Dentistry, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 3335 5968
Fax
Email
a_h_dehgani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Tabriz University of Medical Science
Full name of responsible person
Dr MohamadTagi Cheitsazi
Position
Associated Prof
Other areas of specialty/work
Street address
Faculty of Dentistry, Golghast Ave
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 5968
Fax
Email
chitsazm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Dr Alihossein Dehghani
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Faculty of Dentistry, Golghast Ave
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 5968
Fax
Email
a_h_dehgani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)