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CTRI Number  CTRI/2024/08/072462 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Application of new adhesive material for better bone healing around immediately placed dental implants 
Scientific Title of Study   Development and Implication of Adhesive Scaffold for Regenerative and Mechanical Advances in Immediate Dental Implants 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rameshwari Singhal 
Designation  Professor 
Affiliation  King Georges Medical University 
Address  Department of Periodontology 5th floor New Dental Building King Georges Medical University Lucknow
Faculty of Dental Sciences King Georges Medical University Chowk Lucknow 226003 Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9837400562  
Fax    
Email  rameshwarisinghal@kgmcindia.edu  
 
Details of Contact Person
Scientific Query  
Name  Samiksha Dubey 
Designation  PhD Student 
Affiliation  King Georges Medical University 
Address  Department of Periodontology 5th floor New Dental Building King Georges Medical University Lucknow
Faculty of Dental Sciences King George Medical University Chowk Lucknow 226003 Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9588352789  
Fax    
Email  drsamikshadubey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rameshwari Singhal 
Designation  Professor 
Affiliation  King Georges Medical University 
Address  Department of Periodontology 5th floor New Dental Building King Georges Medical University Lucknow
Faculty of Dental Sciences King George Medical University Chowk Lucknow 226003 Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9837400562  
Fax    
Email  rameshwarisinghal@kgmcindia.edu  
 
Source of Monetary or Material Support  
Department of Periodontology 5th Flooe New Dental Building King Georges Medical University Lucknow UP Pincode 226003 India 
 
Primary Sponsor  
Name  King George Medical University 
Address  Department of Periodontology 5th floor New Dental Building King George Medical University Chowk 226003 Lucknow Uttar Pradesh 
Type of Sponsor  Government medical 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 Rameshwari Singhal  King Georges Medical University  Department of Periodontology 5th Floor New Dental Building Chowk 226003
Lucknow
UTTAR PRADESH 		 9837400562

rameshwarisinghal@kgmcindia.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University UP Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1 or more missing teeth  
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DFDBA Demineralized Freeze Dried Bone Allograft   immediately after extraction of the teeth DFDBA will be placed in the socket using bone graft carrier and implant will be placed 
Intervention  Tissue engineered photopolymerizable injectable adhesive bone regenerative hydrogel scaffold   A tissue engineered adhesive photopolymerizable injectable hydrogel scaffold made of Gelatin Methacrylate and calcium phosphate nanoparticles will be injected in the socket immediately after extraction and implant will be placed in it, once polymerized it will provide initial stabiity and strength  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy adult patients 18 to 60 years both male and female having one or more teeth indicated for extraction are included they must be Negative for allergic testing for ABRS and ready to give written informed consent The jumping gap should be at least 2mm with all 4 cortical plate walls intact around the socket and have D1 D2 or D3 bone type
 
 
ExclusionCriteria 
Details  subjects with history of Smoking alcohol tobacco chewing drugs systemic conditions requiring medication pregnancy lactation history of allergic predisposition are excluded there should not be any acute periapical abcess or cysts existing ridge defect missing one or more cortical bone at the concerned site also mandibular anterior region and D4 bone are excluded 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the effect of ABRS on the primary stability on the dental implants placed in fresh extraction sockets
To assess the effect of ABRS on crestal bone healing and regeneration
To determine the quality and quantity of bone formed around the dental implants
To conduct a comparative evaluation of all the above parameters with the market control
 		 Primary stability will be measured by Radio Frequency Analyzer RFA and insertion torque at baseline 0
The crestal bone level will be measured radiographically at 0 3 6 and 12 months and clinically by probing pocket depth assessment at 0 3 6 and 12 months
For bone healing Peri‐implant crevicular fluid samples will be obtained at 3 7 & 14 days after implant placement for Multiplexing
Quality of bone formed is assessed by DEXA scan at 0 3 6 and 12 months

 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the effect of ABRS on secondary stability on functional loads. to assess the effect of ABRS on the maintenance and healing of soft tissue profiles around dental implant crowns. To assess the functional ability of the implant prosthesis.   secondary stability will be measured by a radio frequency analyzer RFA at 3,6 and 12 months.
soft tissue profile assessment is done by pink esthetic score at 0,7,14 and 28 days and early wound healing index at 0,3,7 and 14 days.
for functional assessment, the PROM questionnaire will be filled at 1,3 and 6 months 
 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   10/12/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Aim - To develop a bio-adhesive bone regenerative scaffold (ABRS) and to asses its clinical efficacy on soft tissue and bone regeneration around the immediate dental implant through a randomized controlled trial 
Material and methodology - ABRS will be developed and characterized in CSIR-IITR Lucknow. 20 healthy adult patients requiring immediate implants will be randomly selected from the Department of Periodontology KGMU Lucknow. they will be allocated to group 1(Test-ABRS) and group 2(control- DFDBA) according to the table of random numbers. standard SLA treated root form dental implants 3.5-5mm wide and 8-12mm long dual thread internal hex design will be placed surgically after extraction in both groups. In group 1 ABRS will be injected in the prepared socket before the implant placement while in group 2 DFDBA will be placed around the implant by graft carrier. implants with a minimal insertion torque of 30Ncm will be loaded immediately. all the clinical and radiographic parameters will be measured at predetermined time points to assess soft tissue and hard tissue regeneration. bone healing will also be assessed through biomarker evaluation by multiplexing in initial 14 days. functional efficacy of the implant prosthesis will be measured subjectively through a PROM questionnaire. all these when statistically analyzed among the two groups will suggest the clinical efficacy of ABRS. 
results - it is assumed that ABRS will enhance the primary and secondary stability of immediately placed dental implants more than the bone graft aiding in immediate functional prosthesis. the superior density of bone and faster bone healing are expected around dental implants in the ABRS group. due to the adhesive nature of the material suture less soft tissue healing is expected to result in a better soft tissue profile. superior functionality of the prosthesis is also anticipated. with this clinical trial, we will be able to provide immediate functional prosthesis to the otherwise contraindicated cases thus improving the quality of life of a major edentulous population.
 
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