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CTRI Number  CTRI/2024/04/065850 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study assess the effect of laser light on stability of implants,density of bone around implants and bio-chemical markers in the fluid around dental implants . 
Scientific Title of Study   Effect of photo-biomodulation on Implant stability, Bone density and Bio-chemical markers in dental implants- A randomized controlled clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakamsani Kavya Sri 
Designation  I MDS Post graduate 
Affiliation  Vishnu dental college 
Address  Room no 7, Block 2, Department of Periodontics and Implantology, Vishnu dental college, Vishnupur, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9494853094  
Fax    
Email  dr.kavyasrilakamsani2112@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Anil Kumar 
Designation  Associate professor 
Affiliation  Vishnu dental college 
Address  Room no 7, Block 2, Department of Periodontics and Implantology, Vishnu dental college, Vishnupur, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9677209549  
Fax    
Email  anilkumar.perio@vdc.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sruthima N V S G 
Designation  Professor 
Affiliation  Vishnu dental college 
Address  Room no 7, Block 2, Department of Periodontics and Implantology, Vishnu dental college, Vishnupur, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9492293808  
Fax    
Email  sruthima@gmail.com  
 
Source of Monetary or Material Support  
Vishnu dental college, Vishnupur, Bhimavaram. 
 
Primary Sponsor  
Name  Dr L Kavya Sri 
Address  Room 7, Block 2, Department of Periodontics and Implantology, Vishnu dental college, Vishnupur, Bhimavaram 
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 
Dr L Kavya Sri  Vishnu Dental College  Room 7, Block 2, Department of Periodontics and Implantology, Vishnu dental college, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH 		 9494853094

dr.kavyasrilakamsani2112@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vishnu Dental College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional implant placement  Implants will be placed without laser photobiomodulation in conventional method. 
Intervention  Photobiomodulation  Denlase diode laser, Wave length-980nm, Energy-6J, time-60seconds, Power-0.1W, continuous, non-contact mode in a sweeping motion. Laser irradiation will be done immediately after osteotomy site preparation, immediately after suture placement and at the time of suture removal. The total duration of the intervention will be for 3min  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Mandibular posterior edentulous areas
2 Age group of 20-60 years.
3 Adequate depth and width of bone should be present.
 
 
ExclusionCriteria 
Details  1 Patients with uncontrolled systemic diseases.
2 Pregnancy or lactating women.
3 Patients under anticoagulant therapy.
4 Chronic smokers.
5 Patients with infectious diseases ( HIV,
Hepatitis - B,C etc )
6 Patients under antibiotic therapy.
7 Patients undergoing radiation therapy.
8 Patients undergoing bis-phosphonate therapy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Implant stability  Implant stability at baseline and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1 Bone density
2 Bio-marker levels( OPG and RANKL)
3 Crestal bone level
4 Healing index(post-surgical
wound healing)
 		 Bone density at baseline and 6 months
Bio-marker levels at 3.5 months and 6 months
Crestal bone level at Baseline and 6 months.
Healing index at 1 week post- surgically 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   29/04/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The aim of this current study is to evaluate the effect of photobiomodulation using 980nm diode laser on implant stability, bone density and bio-chemical markers levels(OPG and RANKL)around dental implants.The total sample size is 22 patients.These patients will be divided in to two groups randomly. Group-A (control) includes 22 patients in which implants will be placed in a conventional approach.Group-B(test)includes  22 patients in which implants will be placed in a conventional approach and laser irradiation using 980nm diode laser  with 6J energy/session, time of 60sec, power of 0.1W in a continuous, non-contact mode in a sweeping motion will be done immediately after osteotomy site preparation on bone, after suturing on soft tissue and after suture removal on the 7th day.The parameters being measured in both the groups are implant stability at baseline and 3 months using resonance frequency analyzer, bone density and crestal bone levels at baseline and 6 months using CBCT, bio-marker levels in PICF at 3.5 months and 6 months using ELISA kits and healing of soft tissues 1 week post-surgically using Hamzani and chaushu’s healing index. 
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