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CTRI Number  CTRI/2018/09/015702 [Registered on: 12/09/2018] Trial Registered Prospectively
Last Modified On: 10/09/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Bloodflow surrounding the soft tissue of Implants with and without Low Level Laser 
Scientific Title of Study   A comparative assessment of vascular flow in peri-implant mucosa by ultrasound Doppler flowmetry, with and without low level laser therapy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  TEJASWI KODEM 
Designation  Post Graduate 
Affiliation  st.joseph dental college and hospital 
Address  St Joseph Dental College And Hospital Room no-8 P.G Division Duggirala Eluru-534003 Andhra Pradesh
St Joseph Dental College And Hospital Room no-8 P.G Division Duggirala Eluru-534003 Andhra Pradesh
West Godavari
ANDHRA PRADESH
534003
India 
Phone  08184847046  
Fax    
Email  tejaswikodem@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrMNaga Sri 
Designation  Professor 
Affiliation  St Joseph Dental College And Hospital 
Address  St Joseph Dental College And Hospital Room no-8 P.G Division Duggirala Eluru-534003 Andhra Pradesh
St Joseph Dental College And Hospital Room no-8 P.G Division Duggirala Eluru-534003 Andhra Pradesh
West Godavari
ANDHRA PRADESH
534003
India 
Phone  8297667304  
Fax    
Email  nagasri.vij@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrMNaga Sri 
Designation  Professor 
Affiliation  St Joseph Dental College And Hospital 
Address  St Joseph Dental College And Hospital Room no-8 P.G Division Duggirala Eluru-534003 Andhra Pradesh
St Joseph Dental College And Hospital Room no-8 P.G Division Duggirala Eluru-534003 Andhra Pradesh
Nellore
ANDHRA PRADESH
534003
India 
Phone  8297667304  
Fax    
Email  nagasri.vij@gmail.com  
 
Source of Monetary or Material Support  
Tejaswi Kodem Door no 2-18-1 L.I.G 43 Sector 6 M.V.PColony Visakhapatnam 
 
Primary Sponsor  
Name  Tejaswi Kodem 
Address  Door no 2-18-1 L.I.G 43 Sector 6 M.V.PColony Visakhapatnam 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tejaswi Kodem  St Joseph Dental College And Hospital  Department Of Periodontics Post Graduate Division Room 8
West Godavari
ANDHRA PRADESH 		 8184847046

tejaswikodem@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Joseph Dental College And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  partially edentulous,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  low level laser  biostimulation 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Systemically Healthy Patients age group 20-50 years Partially edentulous patients. 
 
ExclusionCriteria 
Details  any systemic disease that affects the periodontium are contraindicated for implant placement Patients with psychiatric disorders Inability or Unwillingness ti complete thetrial Patients on Medication poor oral hygiene Pregnant lactating mothers smoking History of alcohol abuse 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The purpose of this study was a comparative assessment of gingival blood flow during healing of implant by ultrasound doppler flowmetry with and without adjunctive low level laser therapy  The purpose of this study was a comparative assessment of gingival blood flow during healing of implant by ultrasound doppler flowmetry with and without adjunctive low level laser therapy 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome of the present study was to comparative assessment of gingival blood flow during healing of implant by ultrasound doppler flowmetry with and without adjunctive low level laser therapy  10 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Dental implants are anchored in jaw bone through a direct bonding between bone and the implant. Success and survival of an implant do, however, not depend solely on osseointegration. A soft tissue, which surrounds the transmucosal part of a dental implant, separates the periimplant bone from the oral cavity. This soft tissue collar is called “periimplant mucosa”Low level laser therapy (LLLT) is widely used during the post-operative period to accelerate the healing process.Doppler sonography is a non-invasive, accurate and simple technique to measure continuous microcirculatory blood flow in many tissues.It works on “Doppler Shift” principle-, measuring the frequency change that light undergoes when reflected by moving objects, such as red blood cells (RBC).

 
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