| 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
|
|
|
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
|
|
|
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
|
|
|
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 |