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CTRI Number  CTRI/2021/04/032917 [Registered on: 19/04/2021] Trial Registered Prospectively
Last Modified On: 15/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A STUDY TO SEE THE EFFECTS OF PLACING A MATERIAL MADE OF PATIENTS OWN BLOOD IN IMPLANT PLACED IMMEDIATELY AFTER REMOVAL OF TOOTH  
Scientific Title of Study   EVALUATION OF THE CLINICAL AND RADIOGRAPHIC EFFECTS OF L-PRF MEMBRANE IN IMMEDIATE POST EXTRACTION IMPLANT PLACEMENT A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr MONAL SONI 
Designation  PG STUDENT 
Affiliation  DAV DENTAL COLLEGE 
Address  ROOM NO 8 Department of periodontology & Oral implantology DAV DENTAL COLLEGE
soni dental centre Tehsil Dehra Distt Kangra
Kangra
HIMACHAL PRADESH
177101
India 
Phone  9816141532  
Fax    
Email  monalsoni.ms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHALINI GUGNANI 
Designation  PROFESSOR 
Affiliation  DAV DENTAL COLLEGE 
Address  PROFESSOR DEPT OF PERIODONTICS Room no 8 DAV DENTAL COLLEGE

Yamunanagar
HARYANA
135001
India 
Phone  9466949150  
Fax    
Email  drshalinigugnani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr MONAL SONI 
Designation  PG STUDENT 
Affiliation  DAV DENTAL COLLEGE 
Address  ROOM NO. 8 DEPT. OF PERIODONTICS DAV DENTAL COLLEGE
soni dental centre Tehsil Dehra Distt Kangra
Kangra
HIMACHAL PRADESH
177101
India 
Phone  9816141532  
Fax    
Email  monalsoni.ms@gmail.com  
 
Source of Monetary or Material Support  
J.N. Kapoor Dav dental college,yamunanagar,Haryana, India 
 
Primary Sponsor  
Name  MONAL SONI 
Address  PG DEPT. OF PERIODONTICS DAV DENTAL COLLEGE YAMUNANAGAR 
Type of Sponsor  Other [PRIVATE DENTAL COLLEGE] 
 
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 Monal Soni   J.N. Kapoor D.A.V Dental College  D.A.V Dental College, Room no. 8,Department of periodontology and oral im[plantology Model town, Yamunanagar
Yamunanagar
HARYANA 		 8219503382

monalsoni.ms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  non- restorable tooth or root stumps 
Patients  (1) ICD-10 Condition: K083||Retained dental root,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  immediate implant without PRF  Stage 1 surgery: The teeth were carefully extracted by using forceps or piezotome in order to protect and preserve the alveolar bone. The socket was curetted and irrigated with sterile saline to ensure no debris or bone chip is left. The depth of the socket was measured to determine the amount of drilling required beyond the root apex tip. Drilling was performed at 600-800 rpm at the predetermined direction guided by the surgical drill guide of an implant. Copious saline irrigation was done to prepare the osteotomy site. Sequential drilling was carried out until the desired dimensions were achieved depending on the selected implant size. Manual key and rachet were used for implant insertion. Implants were placed 2-3mm beyond the apex to achieve primary stability. Each implant was placed manually and rotated clockwise until resistance for seating was achieved. Complete seating of the implant was carried so that the coronal part of the collar of an implant was at or below the crestal bone level of the alveolar ridge. The cover screw was then screwed on the implant body. The buccal & lingual/palatal gingival tissue was approximated and single interrupted sutures were placed. Sutures were removed after 10 days. 
Intervention  L-PRF  PRF membrane will be transferred with PRF forceps to sterile PRF tray to use it at the immediate implant placement site. The membrane will be then taken to surgical site at time of application with the help of PRF spoon. The flap margins will be repositioned and sutured tension free applying simple interrupted sutures with 3-0/4-0 braided silk suture. Sutures will be removed after 10 days. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient with age group between 18-65 years.
2.Patient, who are cooperative, motivated and with good oral hygiene.
3.Patients with no acute infection.
4.Patients with sufficient bone volume at the site of immediate implant placement.
5.Patients who are willing and available for recall follow ups.
6.Teeth indicated for extraction with terminal periodontal disease.
7.Teeth indicated for extraction due to causes like root fracture, grossly decayed, root resorption etc.
 
 
ExclusionCriteria 
Details  1.Patient unable to maintain adequate oral hygiene.
2.Patients with any known systemic disease/conditions and/or on medication known to interfere with wound healing.
3.Patients who are current smokers or consume any other form of tobacco.
4.Patients with para-functional habits & traumatic occlusion.
5.Patients with severe malocclusion or crowding.
6.Teeth with periapical pathologies.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome: evaluation will be done clinically and radiographically.
1.Tissue biotype assessment
2. Radiographic evaluation (standardized Periapical radiograph with grid) for peri-implant bone loss and radiolucency.
 		 AFTER 10 DAYS, 1 MONTH, 3 MONTHS AND 6 MONTHS
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Modified Plaque index
2. Modified sulcus bleeding index
3.Peri-implant pocket depth
4.Implant stability
 		 AFTER 10 DAYS, 1 MONTH, 3 MONTHS AND 6 MONTHS 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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 3/ Phase 4 
Date of First Enrollment (India)   28/04/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

OBJECTIVE- To evaluate the hard and soft tissue outcome of immediate implant placement with or without L-PRF.

METHODOLOGY- A total of 18 immediate implants were placed. Patients were divided into two groups i.e. immediate implants with L-PRF (n=9) and immediate implants without L-PRF (n=9). The patients received a definitive restoration after 3 months of immediate implant placement and were followed up for a period of 6-months.

RESULT- There was significant improvement seen in tissue biotype, probing depth & marginal bone loss in test group as compared to control group.

CONCLUSION- Immediate placement of implants with L-PRF membrane could be considered a valuable option to replace missing tooth with hard and soft tissue regeneration. But, this study looked at very few cases over a limited period. Thus, long-term clinical studies are needed to validate the findings.   
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