| 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
|
|
|
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
|
|
|
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. |