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CTRI Number  CTRI/2023/08/056786 [Registered on: 23/08/2023] Trial Registered Prospectively
Last Modified On: 16/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A research comparing the height of the bone after implant placement in sinus augmented Maxilla on both sides with comparisons of blood clot and Platelet Rich Fibrin 
Scientific Title of Study   Comparative evaluation of clinical and radiographic outcomes of simultaneously placed implant in sinus augmented ridges with blood clot alone versus Platelet Rich Fibrin (PRF): A split mouth randomized clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bathri Elangovan 
Designation  PG student in Department of OMFS 
Affiliation  Government Dental College, Raipur 
Address  Room No.10, 2nd floor, Department of Oral and Maxillofacial Surgery, Government Dental College, Raipur Chhattisgarh, near Marhi Mata Mandir, Rajbandha Maidan, Raipur, Chhattisgarh, 492001

Raipur
CHHATTISGARH
492001
India 
Phone  8870908165  
Fax    
Email  ebathri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Biswajit Mishra 
Designation  Professor and HOD of Department of Oral and Maxillofacial Surgery 
Affiliation  Government Dental College, Raipur 
Address  Room no.10, 2nd floor, Department of Oral and Maxillofacial Surgery, Government Dental College, Raipur, Chhattisgarh, near Marhi Mata Mandir, Rajbandha Maidan, Raipur, Chhattisgarh, 492001

Raipur
CHHATTISGARH
492001
India 
Phone  9893095190  
Fax    
Email  mishra.biswajit08@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Biswajit Mishra 
Designation  Professor and HOD of Department of Oral and Maxillofacial Surgery 
Affiliation  Government Dental College, Raipur 
Address  Room no.10, 2nd floor, Department of Oral and Maxillofacial Surgery, Government Dental College, Raipur, Chhattisgarh, near Marhi Mata Mandir, Rajbandha Maidan, Raipur, Chhattisgarh, 492001

Raipur
CHHATTISGARH
492001
India 
Phone  9893095190  
Fax    
Email  mishra.biswajit08@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College, Raipur, Chhattisgarh 
 
Primary Sponsor  
Name  Bathri Elangovan 
Address  Room no.10, 2nd floor, Department of Oral and Maxillofacial Surgery, Government Dental College, Raipur, Chhattisgarh, near Marhi Mata Mandir, Rajbandha Maidan, Raipur, Chhattisgarh, 492001 
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 Bathri Elangovan  Government Dental College, Raipur  Room no 10, 2nd floor, Department of Oral and Maxillofacial Surgery, near Marhi Mata Mandir, Rajbandha Maidan, Raipur, Chhattisgarh, 492001
Raipur
CHHATTISGARH 		 8870908165

ebathri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies) Government Dental College Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  People with bilateral missing Maxillary posterior teeth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Maxillary sinus augmentation with blood clot alone with immediate implant placement  Probing depth, Vertical bone gain, Bone density is measured at 0, 6, 9 month 
Comparator Agent  Maxillary sinus augmentation with Platelet Rich Fibrin with immediate implant placement  Probing depth, Vertical bone gain, Bone density is measured at 0, 6, 9 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient aged more than 18 years.
Patient with severe atrophy of the posterior maxilla with 4-6 mm of residual bone height.
Patient with a need for implant therapy in the bilateral posterior maxillary region.
Patient coming under the category of ASA I.
Patient with pathology-free sinus.
Patient being without active periodontal diseases. 
 
ExclusionCriteria 
Details  Patient with systemic disease/condition that might interfere with implant placement.
Patient with active periodontal infection.
Patient with history of parafunctional habits.
Patient with habit of chronic smoking
Patient with habit of chronic alcoholics.
Patient undergoing corticosteroid therapy, chemotherapy, radiotherapy.
Pregnant females.
Patient with lack of stable posterior occlusion.
Patient with a history of maxillary sinus pathologic features and/or surgery.
Patient coming under the category of ASA II, III, IV 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Researcher will come to know whether blood clot alone provides better bone gain when
compared with Platelet Rich Fibrin (PRF) after maxillary sinus augmentation with
simultaneous implant placement. 		 6, 9 month 
 
Secondary Outcome  
Outcome  TimePoints 
Researcher will come to know whether blood clot alone provides better bone density when compared with Platelet Rich Fibrin (PRF) after maxillary sinus augmentation with
simultaneous implant placement. 		 6, 9 month 
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
Final Enrollment numbers achieved (Total)= "6"
Final Enrollment numbers achieved (India)="6" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2023 
Date of Study Completion (India) 15/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 07-08-2024 and end date provided 07-08-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 A dental implant is a biocompatible material placed into or onto the jawbone for prosthetic rehabilitation of a lost tooth. The vertical and horizontal bone volume in the posterior maxilla is important for implant placement.  Ridge resorption and pneumatization of the maxillary sinus, as well as the poor quality of bone, may also make the implant rehabilitation of the posterior maxilla more challenging.  Maxillary Sinus floor augmentation is the process in which the bone height and width is increased in order to stabilize the implant.  Sinus floor can be augmented with or without the use of any grafts. PRF is considered a second-generation platelet concentrate because the natural concentrate is a product without any anticoagulants.  If grafts are not used, the blood clot formed under the lifted maxillary sinus Schneiderian membrane appears to be critical importance in bone neoformation potential.  The purpose of the study is to compare the vertical bone gain, bone density and probing depth of simultaneously placed implants in sinus augmented ridges with blood clot alone versus platelet rich fibrin (PRF).  
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