| 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
|
|
|
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
|
|
|
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
|
|
|
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. |