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CTRI Number  CTRI/2024/06/069606 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
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 compare how well amniotic membrane and platelet rich fibrin membranes help bone healing around dental implants after sinus lift surgery. 
Scientific Title of Study   Comparative evaluation of amniotic membrane and platelet rich fibrin membrane on osseous healing post direct maxillary sinus lift augmented with graft around dental implants A randomised controlled 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  Sonali Kaundal 
Designation  Junior Resident 
Affiliation  King George Medical University, Lucknow, Uttar Pradesh 
Address  Resident room, sixth floor, Department of Prosthodontics and Crown and Bridge, King George Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  6230006455  
Fax    
Email  sonalikaundal1964@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kaushal Kishor Agrawal 
Designation  Professor Junior Grade 
Affiliation  King George Medical University 
Address  sixth floor, Department of Prosthodontics and Crown and Bridge, King George Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  8299612318  
Fax    
Email  drkaushalp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sonali Kaundal 
Designation  Junior Resident 
Affiliation  King George Medical University, Lucknow, Uttar Pradesh 
Address  Resident room, sixth floor, Department of Prosthodontics and Crown and Bridge, King George Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  6230006455  
Fax    
Email  sonalikaundal1964@gmail.com  
 
Source of Monetary or Material Support  
New Dental building Sixth floor King George Medical University Lucknow Uttar Pradesh 
 
Primary Sponsor  
Name  King George Medical University 
Address  Seminar room, sixth floor, Department of Prosthodontics, Crown and Bridge, New Dental Building, Lucknow 
Type of Sponsor  Government medical 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 Sonali Kaundal  King George Medical University  Department of Prosthodontics, Crown and Bridge, New dental building, Sixth floor, Postgraduate Clinic
Lucknow
UTTAR PRADESH 
6230006455

sonalikaundal1964@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, King George Medical University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amniotic membrane  After local anaesthesia and incision, mucoperiosteal buccal flap will be elevated to expose a portion of lateral bony wall of maxillary sinus and direct sinus lift procedure will be performed. Sinus membrane will be kept elevated and osteotomy for implant will be prepared. Implant will be placed and xenograft is placed followed by direct placement of amniotic membrane covering the window(defect area) over xenograft. Flap is closed and follow up of bone healing is done at one week, one month and at six months. 
Comparator Agent  Platelet rich fibrin membrane  placement of Platelet rich fibrin membrane obtained from patients blood will be placed over xenograft. Rest all the procedure is same. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Healthy adult patients free from any compromising systemic diseases.
2. Patients need implant insertion in maxillary premolar/molar area.
3. Severely resorbed maxillae having less than 5mm in height and more than 7mm in width of residual alveolar bone.
4. Adequate inter occlusal space that could accommodate the implant abutment and the future restoration.
 
 
ExclusionCriteria 
Details  1. Uncontrolled systemic diseases which retard bone healing.
2. Patients who are under bisphosphonates.
3. Presence of any pathology in site of operation.
4. History of maxillary sinusitis or sinus surgery.
5. Heavy smokers
6. Pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare osseous healing around dental implants in both the groups  1 week, 1 month, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Absolute and percentage change in area
Change in Peak Systolic Velocity 
1 week, 1 month, 6 months 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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 
Date of First Enrollment (India)   10/07/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

It is difficult to restore an edentulous posterior maxilla with dental implants due to poor bone equality & limited available bone length, and sinus floor augmentation may be a crucial surgical operation for bone augmentation in this area prior to implant placement. Implant insertion in an atrophic maxilla may be hampered by inadequate alveolar ridge breadth and bone height. The posterior maxilla implant rehabilitation may be more difficult due to ridge resorption, maxillary sinus pneumatization, and low bone quality.

A reliable and efficient medical procedure is sinus floor augmentation.There have been a number of procedures proposed for the vertical augmentation of the maxillary sinus, with the conventional lateral osteotomy—introduced by Tatum in 1976—remaining the most popular. It is possible to complete the lateral augmentation surgery in one or two phases. The two-stage method refers to placing dental implants after bone healing, whereas the one-stage procedure refers to placing dental implants concurrently with sinus floor augmentation.

In the lateral sinus floor augmentation surgery, there are some variations in the graft materials used for bone augmentation and the timing of implant insertion (simultaneous or delayed).

Autogenous bone from the iliac crest or maxillary tuberosity, frozen bone, freeze-dried bone, xenogeneic bone, demineralized freeze-dried bone, and hydroxyapatite have all been studied for use in maxillary sinus grafts to speed up the bone healing process and prevent repneumonization of the maxillary sinus after grafting. Recent research on sinus transplants has revealed that the type of bone-graft material utilised can have a different impact on long-term outcomes.

Human amniotic membrane (hAM), one of these biologically/naturally generated tissues, has been used in medicine since Dr. Nicholas Sabella first described a clinical case of burns treated by hAM in 1900.It has been documented to have an anti‐ inflammatory, antimicrobial, anti‐tumorigenic nature and analgesic action on local application. The components of hAM, collagen, laminin, fibronectin, and elastin, make them ideal for creating a strong framework for tissue engineering. hAM is biologically active compared to other membranes because it releases growth factors that promote cell migration and promote repair. It can be used with different scaffolds and grafts, such as PRF and hydroxyapatite bone graft, or utilised as an occluding membrane in guided tissue regeneration (GTR). To the best of our knowledge, there have been no studies examining hAM’s impact on the maxillary sinus lift surgery with bovine bone graft in comparison to platelet-rich fibrin. Therefore, the purpose of the current study is to evaluate and compare the impact of hAM and Platelet-rich fibrin membrane on Osseous healing and Angiogenesis when combined with a xenograft around dental implants.

Aim of the study is to compare the effect of amniotic membrane versus platelet rich fibrin membrane on osseous healing post direct sinus lift augmented with graft around dental implants.

 
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