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CTRI Number  CTRI/2021/12/038608 [Registered on: 14/12/2021] Trial Registered Prospectively
Last Modified On: 13/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of T-PRF and DFDBA in socket preservation for implant placement. 
Scientific Title of Study   Evaluation of the effectiveness of titanium-prepared platelet rich fibrin (T-PRF) and demineralized freeze-dried bone allograft (DFDBA) in socket preservation followed by implant placement using two stage approach.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranu Oza 
Designation  Post graduate student 
Affiliation  Post graduate student, Sharad Pawar Dental College 
Address  Department of Periodontics, Sharad Pawar Dental College, Wardha, Sawangi, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  08669021556  
Fax    
Email  ranuoza@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasad Dhadse 
Designation  Professor and Head 
Affiliation  Professor and Head, Sharad Pawar Dental College 
Address  Department of Periodontics, Sharad Pawar Dental College, Wardha, Sawangi, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  09822689401  
Fax    
Email  drprasaddhadse@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ranu Oza 
Designation  Post graduate student 
Affiliation  Post graduate student, Sharad Pawar Dental College 
Address  Department of Periodontics, Sharad Pawar Dental College, Wardha, Sawangi, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  08669021556  
Fax    
Email  ranuoza@gmail.com  
 
Source of Monetary or Material Support  
Sharad Pawar Dental College and Hospital, Sawangi, Meghe, Wardha, 442001 
 
Primary Sponsor  
Name  Sharad Pawar Dental College and Hospital 
Address  Sharad Pawar Dental College and Hospital, Wardha:442001 
Type of Sponsor  Research institution and hospital 
 
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 Ranu Oza  Sharad Pawar Dental College and Hospital  Department of Periodontics, Room number 03, Wardha, Sawangi, 442001
Wardha
MAHARASHTRA 
07588415693

ranuoza@gmail.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  Root piece  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Atraumatic extraction followed by ridge preservation. Implant placement after 3 months  Ridge preservation using DFDBA+T-PRF Intraoral placement of T-PRF and DFDBA into extraction socket. After 3 months dental implant to be placed 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion criterias:
1. Tooth indicated for extraction. Reasons might be any one like, fracture of root, failure of endodontic treatment, resorption (internal and external), over-retained primary teeth, non-restorable carious lesions, residual roots.
2. Oral hygiene indicated with plaque score ≤ 25%.
3. Presence of opposing natural tooth.
4. Presence of adjacent teeth.
5. Thick gingival biotype.
6. Radiographic and clinical appearance of intact alveolar bony walls.
7. 4 mm of bone radiographically at root apex
8. D-1, D-2 or D-3 bone quality.
 
 
ExclusionCriteria 
Details  Exclusion criterias:
1. Patients with impaired systemic health that would interfere with the process involved with repair and healing of bones e.g. (Diabetes mellitus, Osteoporosis, Blood disorders, and Titanium allergy).
2. Significant differences in maxilla-mandibular space.
3. Presence of para functional habits such as bruxism or clenching.
4. Presence of proclined teeth, teeth with interdental spacing, rotated or mal-aligned anterior teeth.
5. History of alcoholism, excessive smoking or drug abuse.
6. D-4 bone quality.
7. Width of keratinized gingiva less than 2mm at implant site.
8. Debilitating tempro-mandibular joint pathosis.
9. Untreated dental diseases.
10. Pregnant and lactating mothers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate bucco-lingual changes of sockets before and after ridge preservation.
2. To evaluate vertical and horizontal crestal bone changes around post extraction implant placement.
3. To evaluate success rate of delayed implant placement in ridge preservation / socket preservation.


 
To be evaluated after 3 months of ridge preservation and then after 3 months of implant placement 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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   N/A 
Date of First Enrollment (India)   15/12/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

ABSTRACT

Background: Implant dentistry has evolved over time with various novel protocols. The focus of the implant therapy is now shifting to a stable restoration rather than mere osseointegration. Placement of dental implants has become an indispensable part of mainstream dentistry, offering an improved quality of life to patients. The primary indicator for the repair or preservation of osseous structures following disease or trauma is the rehabilitation of edentulous ridges to allow the installation of endosseous implants. One of the physiological changes that occurs after tooth extraction is alveolar ridge resorption.  The first year after tooth extraction sees major dimensional shifts in the extraction socket, with two-thirds of the bone loss occurring during the first three months. A variety of bone graft materials and platelet concentrates which are abundant in growth factors have been incorporated that provides the added effect of combination for early and better healing.

Objectives: Evaluation of effectiveness of “Titanium Prepared Platelet Rich Fibrin”(T-PRF) and “Demineralized Freeze-Dried Bone Graft”(DFDBA) in socket preservation and simultaneous evaluation of implant stability  three months after implant placement using two stage protocol.

Methodology: Present study will be performed over one year period. Twelve patients, each having one tooth indicated for extraction in either of the arches will be selected. Atraumatic extraction will be done followed by socket preservation using combination of T-PRF and DFDBA to promote early healing followed by placement of implant.

Expected results: We expect early and better results of bone formation in healing sockets after preservation using T-PRF and DFDBA, which will be advantageous for implant placement. Better results in terms of bone volume, bone height, bone density and histomorphometry are expected.

Conclusion: Combination of T-PRF and DFDBA is expected of creating novel outcomes.

Keywords: T-PRF, Socket Preservation, Dental Implant, DFDBA.

 
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