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CTRI Number  CTRI/2024/03/064426 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinically and Radiologically comparing the efficiency of two different blood derivatives of patient, when used along with Implants that are placed on the same day of extraction and measuring stability of Implant and Bone loss around the Implant. 
Scientific Title of Study   A COMPARATIVE EVALUATION OF IMPLANT STABILITY AND BONELOSS IN IMMEDIATELY PLACED IMPLANT IN FRESH EXTRACTION SOCKET WITH PLATELET RICH FIBRIN AND WITH ADVANCED-PLATELET RICH FIBRIN-A CLINICAL AND RADIOGRAPHIC STUDY 
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 Mukesh kistamolla 
Designation  PG student 
Affiliation  Sharavathi Dental College and Hospital 
Address  The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no:3, Sharavathi Dental College and Hospital, Shimoga.
T.H road, Alkola, Gadikoppa, Opposite Nanjappa Life Care Hospital, Shimoga.
Shimoga
KARNATAKA
577205
India 
Phone  9603469696  
Fax    
Email  kistamollamukesh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhilash a 
Designation  Professor 
Affiliation  Sharavathi Dental College and Hospital 
Address  The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no: 3, Sharavathi Dental College and Hospital, Shimoga.
T.H road, Alkola, Gadikoppa, opposite Nanjappa Life Care Hospital, Shimoga.
Shimoga
KARNATAKA
577205
India 
Phone  9480327026  
Fax    
Email  drabhilashmysore@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhilash a 
Designation  Professor 
Affiliation  Sharavathi Dental College and Hospital 
Address  The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no:3, Sharavathi Dental College and Hospital, Shimoga.
T.H road, Alkola, Gadikoppa, opposite Nanjappa Life Care Hospital, Shimoga.
Shimoga
KARNATAKA
577205
India 
Phone  9480327026  
Fax    
Email  drabhilashmysore@gmail.com  
 
Source of Monetary or Material Support  
The Department of prosthodontics and Crown and Bridge and Implantology, Room no:3, Sharavathi Dental College and Hospital, T.H road, Alkola, Shimoga. 
 
Primary Sponsor  
Name  Dr Mukesh kistamolla 
Address  The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no:3, Sharavathi Dental College and Hospital, Shimoga. 
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 Mukesh kistamolla  Sharavathi Dental College and Hospital  The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no:3.
Shimoga
KARNATAKA 
9603469696

kistamollamukesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sharavathi Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endosseous Implant with Advanced platelet rich fibrin  Using 1500 RPM for 14 minutes in a centrifugal machine and using the Advanced platelet rich fibrin achieved from it. 
Intervention  Endosseous Implant with Platelet rich fibrin  Using 2700 RPM for 12 minutes in a centrifugal machine and using the Platelet rich fibrin achieved from it. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Generalised good periodontal health.
2.Presence of tooth/ root stump indicated for extraction in posterior region of maxilla and mandible without any acute infections.
3.Favourable root anatomy.
 
 
ExclusionCriteria 
Details  1.Inadequate oral hygiene.
2.Dilacerated and Ankylosed tooth.
3.Acute Peri-apical and periodontal infection in teeth indicated for extraction.
4.Chronic tobacco users.
5.Severe bruxism or clenching habits.
6.Presence of conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids. E.g.; history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements etc.
7.History of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, alcohol or drug abuse, etc
8.History of leucocyte dysfunction and deficiencies and history of neoplastic disease requiring the use of radiation or chemotherapy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To achieve implant stability quotient above 60   at baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To achieve implant stability quotient around 90 & to achieve minimal or no bone loss.  at baseline, 3 months, 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   N/A 
Date of First Enrollment (India)   05/04/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The goal of modern dentistry is to prevent tooth loss and provide a healthy dentition with optimal functional efficiency, structural balance, and esthetic harmony. Implants have been used to support dental prostheses for a few decades. They are the nearest equivalent replacement of natural teeth and are therefore used in the management of patients who are missing teeth due to caries, trauma, or developmental anomalies.

          Traditionally, before placing dental implants, the compromised teeth are removed and the extraction socket is left to heal for a period of few months to 1 year. This waiting period is associated with unavoidable bone loss that occurs after tooth extraction, which may lead to difficulties such as insufficient bone at the time of implantation and prolonged waiting period for the patient. To overcome this, Lazzara (1989) first reported placement of immediate implant in an extraction socket in humans.

           Immediate Implant Placement (IIP) has several advantages such as fewer surgical procedures, preservation of bone volume and the overall treatment time has been reduced, a second surgical intervention is avoided by combining extraction, and implant placement into one appointment. Atraumatic or minimally traumatic extraction is crucial for the success of IIP as the need for alveolar preservation is necessary to have a good functional and aesthetic outcome with implant therapy. To ensure the same; luxators and periotomes were used, thus inflicting the least mechanical trauma to the buccal and lingual cortical bone. With Immediate post-extraction implants it is possible to obtain a very high long-term success percentage (90%), and better and faster functional results. Therefore, it can be a viable treatment alternative in implant dentistry, to improve clinical outcomes and provide better patient compliance and satisfaction.

        The implants are placed based on the extraction socket classification given by Smith R B et al (2013), which comprises Type A, Type B, and Type C based on the bone available within the socket for stabilization of an immediately placed implants.

          The use of platelet concentrates such as Platelet-Rich Plasma (PRP), Platelet-Rich Fibrin (PRF) has gained increasing awareness in recent years for regenerative procedures in modern dentistry. PRF was first developed in France by Choukron et al. It is nothing more than centrifuge blood without any anticoagulant, or bovine thrombin. The various platelet concentrates have quite different release kinetics; the advantage of PRP is the release of significantly higher proteins at an earlier period whereas PRF displayed a continual steady release of growth factors like transforming growth factor β (TGFβ-1), platelet-derived growth factors (PDGFs), and insulin-like growth factors (IGFs) over a 10-day period. Furthermore, new formulations of PRF i.e., Advanced-PRF released significantly higher total quantities of growth factors when compared to traditional PRF, hence recommended for long-term release. The presence of immune cells in A-PRF influences the differentiation and maturation of macrophages. This may lead to soft and hard tissue regeneration, mainly through macrophages by growth factor release. 

        The criteria for success of an implant include no mobility of implant, no peri-implant radiolucency, less marginal bone loss, and no persistent symptoms such as pain, infections, paresthesia, etc., Literature has shown that A-PRF has higher benefits when compared with traditional PRF.

Thus, this study aims to focus on the comparative evaluation of implant stability and bone loss in immediately placed implant in fresh extraction socket with PRF and with A-PRF.

 
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