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CTRI Number  CTRI/2025/03/082403 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 15/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of the bone changes in patients receiving crushed tooth material as a space filler around dental implants when placed immediately after removal of the tooth in the extraction site.  
Scientific Title of Study   Evaluation of the osteoblastic activity and bone dimensional changes in patients receiving demineralized dentinal matrix autograft with varied particle size in immediate implant placement- a Randomized controlled clinical trial  
Trial Acronym  NIL 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranay Jain 
Designation  Post Graduate  
Affiliation  Department of Prosthodontics(Room No.8, Third Floor), Sri Ramachandar Dental College,Sri Ramachandra Institute of Higher Education and Research 
Address  D6 Uptown Apollo DB City, Nipania, Indore, Madhya Pradesh

Indore
MADHYA PRADESH
452011
India 
Phone  7024441558  
Fax    
Email  drpranayjain1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. V Anand Kumar  
Designation  Professor 
Affiliation   
Address  51/8 Soundharya colony Anna nagar west extn.

Chennai
TAMIL NADU
600101
India 
Phone  9444121616  
Fax    
Email  drpranayjain1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pranay Jain 
Designation  Post Graduate  
Affiliation  Department of Prosthodontics(Room No.8, Third Floor), Sri Ramachandar Dental College,Sri Ramachandra Institute of Higher Education and Research 
Address  D6 Uptown Apollo DB City, Nipania, Indore, Madhya Pradesh

Indore
MADHYA PRADESH
452011
India 
Phone  7024441558  
Fax    
Email  drpranayjain1@gmail.com  
 
Source of Monetary or Material Support  
Pranay Jain 
 
Primary Sponsor  
Name  Pranay Jain 
Address  D6 Uptown Apollo DB City, Nipania, Indore, Madhya Pradesh 452010 
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 V Anand Kumar  Sri Ramachandra Institute of Higher Education and Research   Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600116 Tamil Nadu, India
Chennai
TAMIL NADU 
9444121616

anand_anandhi@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients having root stumps or grossly decayed teeth willing for replacement through dental implants. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Demineralized Dentinal Autograft of 0.25mm-1mm  The tooth will be grounded into 0.25mm-1mm particle size which will be a demineralized and autoclaved graft and will be placed in the jumping gap. Dose - Equal amount of the graft which is ground. Frequency - Once  
Intervention  Demineralized Dentinal Autograft of 1mm-2mm  The tooth will be grounded into 1mm-2mm particle size which will be a demineralized and autoclaved graft and will be placed in the jumping gap.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Mandibular Molars indicated for extraction when -
• Root stumps without periapical pathology
• Fractured teeth due to trauma, caries
• Endodontically treated teeth
• Periodontally compromised teeth
• Non- restorable decayed teeth
 
 
ExclusionCriteria 
Details  • Periapical pathology including cyst, granuloma, abscess
• History of radiotherapy and chemotherapy
• History of Uncontrolled diabetes
• Bleeding disorders
• Drug abuse
• Uncontrolled Hypertension
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess bone dimensional changes around immediately placed implants using CBCT at four different time points.  0 days, 30 days, 90 days, 180 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the osteoblastic activity around immediately placed implants with two different particle sizes using scintigraphy at three different time points.  15 days, 45 days, 90 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   Phase 4 
Date of First Enrollment (India)   31/03/2025 
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="0"
Months="6"
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  

Different biomaterials, ranging from synthetic products to autologous or heterologous grafts, have been suggested for bone preservation and regeneration during immediate implantology [1]. A jumping gap greater than 2 mm requires grafting with a bone substitute to regenerate hard tissue, which, in turn, helps maintain the soft tissue configuration [2]. This process enhances the thickness of the labial bone plate, showing superior outcomes compared to spontaneous healing through blood clot formation alone [3]. Use of autograft is found to be superior however, due to the additional invasive procedures and morbidity associated with autograft donor sites, special attention has been given to demineralised dentine autograft as a biomaterial for bone regeneration [4].

Demineralized dentin stimulates bone regeneration and has mechanisms similar to autologous bone grafts. It shows high biocompatibility and promotes rapid bone regeneration by maintaining an ideal balance between bone resorption and formation. Additionally, demineralized dentin has several advantages, such as faster recovery times, high-quality newly formed bone, low costs, no risk of disease transmission, the ability to be used in outpatient procedures, and no donor-related postoperative complications [1]. Autogenous DDM granules act as an excellent, readily available alternative to other bone graft materials in cases of immediate implant cases [7].

Studies have shown that there’s high resorption rate of demineralized dentinal autograft in around 3 months which replaces the bone without inflammation. [5]. However, higher resorption rate may be related to loss of bone volume. Studies conducted with allograft and xenograft showed that the particle size of grafts can also play a pivotal role in bone regeneration.  Smaller particles have a larger surface area relative to their volume, which makes them more accessible to osteoclasts, the cells responsible for bone resorption. This leads to faster degradation and remodelling of the graft material into new bone. In contrast, larger particles may resorb more slowly, providing prolonged structural support.[6]

 By identifying the most effective particle size for specific graft materials, clinicians can improve the efficiency of bone regeneration procedures, minimizing complications and maximizing patient outcomes. Hence, the influence of particle size of DDM Autograft during immediate implant placement in promoting osseointegration is yet to be ascertained.

 
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