The effect of low level laser therapy on the ridge preservation process using growth factors enriched plasma and demineralized bone matrix: A Clinical trial
The aim of this study is to find out the clinical and radiographic effect of Adding LLLT (low-power lasers therapy) to PRP (platelet rich plasma) and DBM (Demineralized bone matrix) in the process of socket preservationon the height and width of ridge and also study the histological Above-mentioned materials effect on the Value of vital bone extraction of Multi-root teeth.and Achieving to a method that could Offering In terms of quantity and quality a better bone for correct and without problem putting up implant for clinicians. In this study, Patients are chosen that refer for treatment of isolated teeth (non-muller) and these teeth were beyond repair and in terms of prognosis have been considered hopeless and also has healthy adjacent teeth and they tend to use the implant. These patients become aware in the form of Written and oral from the Study conditions and after complete the written consent and questionnaire they enter to the study. Forty socket in Patients over 18 years that at least have a Non-maintenance multi-root teeth and elected due to the study output metrics and randomly (using randomizer software: http://www.randomizer.org) divided into two groups (each 14). Initial Clinical criteria Contains Width and height of bone and Width of Keratinized gum are measured. And stents are made for Patients in order to standardize the measured variables. And a CBCT scan is taken of each patient.
After tooth Extraction with minimal trauma and without pressure to the Buccal bone and with using periotome socket carefully bring out the debridement granulation tissue and two treatment Protocol Contains: in first group we use PRP and demineralized bone matrix for fill the socket and in second group we use PRP and demineralized bone matrix for fill the socket with LLLT. All of the sockets completely covered by absorbent collagen membrane and coronally advanced flap and close it by using reverse cross-mattress suture technique. Instructions are given to the patient after surgery and patients are recommended to use Chlorhexidine Gluconate 0.12% Mouthwashes twice a day for two weeks. after 10 days for Suture removal and examination Restoration Area Patients will visit again.Re-evaluate the clinical criteria will be measured Three month after process of bone repair with using stents that were - Build as a guide in 4 place : mid-buccal , mid-ligual , mid-mesial and mid-distal .and also with using trephine concurrent with implant placement preparation of histological samples from bone in that area and for check the value and rate of new bone formation , residual particle , connective tissue and vital bone are sent to the laboratory.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042410501N4
Registration date:2015-12-11, 1394/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-11, 1394/09/20
Registrant information
Name
Nader Abolfazli
Name of organization / entity
Departyment of periodontics, Tabriz faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
abolfazli@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Gum and Tooth Research Center Of Dental College, Tabriz University Of Medical Sciences
Expected recruitment start date
2014-12-23, 1393/10/02
Expected recruitment end date
2015-04-29, 1394/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low level laser therapy on the ridge preservation process using growth factors enriched plasma and demineralized bone matrix: A Clinical trial
Public title
The effect of low level laser therapy on the ridge preservation process
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:Age (18 years or older) ;complete and sign a written consent form; tend to use the implant restoration; clinically at least have one non-molar teeth that need to be extract ; good general health ; the ability to participate in follow up examinations. Exclusion criteria: systemic or topical antibiotics up to three months before the start of study ;regular use of anti-inflammatory drugs in the last three months; Dental infections and bone abscesses ;Poor oral hygiene (no visible plaque); Smoking;ankylosed teeth; pregnancy and lactation; the presence of severe periodontal disease activist; uncontrolled diabetes and debilitating systemic diseases ;people addicted to drugs and alcohol;teeth with Fenestration or Dissidence
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Science
Street address
Department of Periodontics, Faculty of Dentistry, Daneshgah Street
City
Tabriz
Postal code
5516613345
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
TBZMED.REC.1394.448
Health conditions studied
1
Description of health condition studied
Alveolar ridge atrophy
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
Ridge bone dimensions
Timepoint
3 month after the start of study
Method of measurement
With photos gauge and probing
2
Description
new bone formation
Timepoint
3 month after the start of study
Method of measurement
by histologic survey
Secondary outcomes
empty
Intervention groups
1
Description
using enriched plasma in case group
Category
Prevention
2
Description
using low level laser in case group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department Of Periodontics, Tabriz Faculty Of Dentistry
Full name of responsible person
Dr. Nader Abolfazli
Street address
Department of Periodontics, Faculty of Dentistry, Daneshgah Street
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for research of Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Faculty Of Dentistry, Daneshgah Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for research of Tabriz 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
Tabriz Faculty Of Dentistry
Full name of responsible person
Dr. Nader Abolfazli
Position
Associate Professor of Periodontics
Other areas of specialty/work
Street address
Faculty Of Dentistry, Department Of Periodontics, Daneshgah Street
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
Abolfazli@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical sciences, Faculty of Dentistry
Full name of responsible person
Dr. Nader Abolfazli
Position
Associate Professor of periodontics
Other areas of specialty/work
Street address
Department of Periodontics, Faculty of Dentistry, Daneshgah Street
City
Tabriz
Postal code
5516613345
Phone
+98 4109377841412
Fax
Email
abolfazli@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Fatemeh Kavoosi
Position
Post Graduate Student Of Periodontics, Professional Doctorate
Other areas of specialty/work
Street address
Department of Periodontics, Faculty of Dentistry, Daneshgah Street
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
fatimah.kavoosi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)