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CTRI Number  CTRI/2025/08/092222 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   dental implant surface treatment by different chemicals before placement 
Scientific Title of Study   Evaluation of Hard Tissue Outcomes Around Bisphosphonate - Coated and Injectable-Platelet Rich Fibrin - Coated Dental Implants: A Randomized 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 Purbabha Mondal 
Designation  Junior resident 
Affiliation  Institute of dental sciences Bareilly 
Address  Room number 228 Department of periodontics Institute of dental sciences Bareilly
room number 223 Department of periodontics Institute of dental sciences Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  09340661796  
Fax    
Email  purbabha123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akanksha Singh 
Designation  Associate professor 
Affiliation  Institute of dental sciences Bareilly 
Address  Room number 228 Department of periodontics Institute of dental sciences Bareilly
room number 223 Department of periodontics Institute of dental sciences Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  7081222230  
Fax    
Email  akkisingh014@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akanksha Singh 
Designation  Associate professor 
Affiliation  Institute of dental sciences Bareilly 
Address  Room number 228 Department of periodontics Institute of dental sciences Bareilly
room number 223 Department of periodontics Institute of dental sciences Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  7081222230  
Fax    
Email  akkisingh014@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Institute of dental sciences 
Address  Room number 228 department of periodontics institute of dental sciences Bareilly 243006 
Type of Sponsor  Other [Private dental college ] 
 
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 Purbabha Mondal  Department of periodontics  Department of periodontics Institute of dental sciences Bareilly
Bareilly
UTTAR PRADESH 
09340661796

purbabha123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instututional ethics committee IDS Bareilly UP   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bisphosphonate coating over dental implant   bisphosphonate coating will be applied to the implant surface before placement. 35 mg sodium alendronate tablet will be crushed and dissolved in saline with concentration of 20 mg per 1 ml of normal saline 
Comparator Agent  Injectable platelet rich fibrin coating over dental implant  Injectable platelet rich fibrin will be injected around the implant and soft tissues at the time of placement Preparation of iPRF 10 ml of blood will be centrifuged at 700 rpm for 3 minutes After centrifugation the straw colored liquid at the top was drawn into a syringe and carefully applied over the implant surface 
Intervention  uncoated dental implants  uncoated implants will be placed as per standard procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthy adult patients requiring single or multiple dental implants
Adequate interocclusal and mesiodistal space in the edentulous area
Sufficient bone volume in the implant site confirmed through pre-operative CBCT
 
 
ExclusionCriteria 
Details  Patient with any systemic disease like uncontrolled diabetes hypothyroidism
Patient with habits of smoking or heavy alcohol consumption parafunctional habit
Patients currently undergoing steroids or medications which are known to affect bone metabolism osteoporosis and history or chemotherapy at least 6 months prior to implant placement coagulation defects or currently on anticoagulant treatment
4. Pregnant or lactating women
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess and compare peri implant bone density and volume changes across bisphosphonate coated iPRF coated and uncoated implants using CBCT
To evaluate extent of crestal bone level changes across three groups using CBCT
 
1 month 3 months 6 months post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate extent of crestal bone level changes across three groups using CBCT
 
1 month 3 months 6 months post surgery 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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   Phase 3 
Date of First Enrollment (India)   16/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
My thesis focuses on evaluating and comparing the clinical performance of dental implants coated with bisphosphonates and injectable platelet rich fibrin against standard uncoated implants with specific emphasis on peri implant hard tissue outcomes

Dental implants rely heavily on osseointegration the direct structural and functional connection between living bone and the surface of an implant However achieving optimal and long term stability depends not only on mechanical placement but also on biological enhancements that support bone regeneration and prevent bone loss

To improve these biological outcomes my study explores two advanced surface modification techniques

Bisphosphonate coating known for its antiresorptive properties which helps prevent bone resorption by inhibiting osteoclast activity and maintaining bone density


Injectable platelet rich fibrin  a regenerative biomaterial rich in autologous growth factors that promotes angiogenesis fibroblast activity and new bone formation



Using cone beam computed tomography as the imaging modality the study measures changes in bone density bone volume and crestal bone levels over a 6 month period following implant placement The research involves three groups bisphosphonate coated implants iPRF coated implants and uncoated implants and applies a randomized clinical trial methodology to ensure unbiased comparisons

The primary objective is to determine whether these coatings can enhance osseointegration and reduce bone loss around the implants thereby improving implant success rates The findings aim to provide valuable insights for clinicians on the potential benefits of surface bioactivation in implant dentistry and contribute to more predictable treatment outcomes
 
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