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CTRI Number  CTRI/2024/08/072281 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study clinical and radiographic difference between two techniques of maxillary sinus lifting and simultaneous implant placement  
Scientific Title of Study   Comparative Evaluation of Clinical and Radiological Outcomes using Crestal Approach Sinus Kit and Osseodensification by Densah Burs for Sinus Membrane Elevation – 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 Ayushi Arvind Nagdeve 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department No. 202 Second Floor Government Dental College And Hospital Medical Square Hanuman Nagar Nagpur 440003 Maharashtra India

Nagpur
MAHARASHTRA
440003
India 
Phone  917276900857  
Fax    
Email  drojayu.nagdeve@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek Thombre  
Designation  Associate Professor  
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department No.202 Second Floor Government Dental College And Hospital ,Medical Square Hanuman Nagar Nagpur 440003

Nagpur
MAHARASHTRA
440003
India 
Phone  9860478817  
Fax    
Email  drvivekthombre@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivek Thombre  
Designation  Associate Professor  
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department No.202 Second Floor Government Dental College And Hospital Medical Square Hanuman Nagar Nagpur 440003

Nagpur
MAHARASHTRA
440003
India 
Phone  9860478817  
Fax    
Email  drvivekthombre@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College And Hospital, Hanuman Nagar, Nagpur 440003 State-Maharashtra  
 
Primary Sponsor  
Name  Dr Ayushi Arvind Nagdeve 
Address  Department No 202, Department Of Periodontology Second Floor Government Dental College And Hospital Nagpur 440003 
Type of Sponsor  Other [Self sponsor ] 
 
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 Ayushi Nagdeve  Government dental college and hospital   Department no 202 Government Dental College And Hospital Nagpur 440003
Nagpur
MAHARASHTRA 
7276900857

drojayu.nagdeve@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Crestal Approach Sinus Kit for Sinus Membrane Elevation  Patients receiving Implants using Crestal Approach Sinus Kit for Indirect Sinus lift procedure 
Comparator Agent  Osseodensification by Densah Burs for Sinus Membrane Elevation  Patients receiving Implants using Osseodensification by Densah Bur Protocol for Indirect Sinus lift procedure  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Systemically healthy patients requiring and opting Dental
Implants for replacement of missing teeth in maxillary
posterior region
2. Patient with Sub-antral Height between
5-8mm (SA-2 / SA-3)
3. Adequate Bucco-palatal width in the
edentulous area
4. Patients Having D3 or D4 bone density
5. Patient with age between 25-55 years
 
 
ExclusionCriteria 
Details  1. Patients with systemic diseases that contraindicates the
surgery, immune compromised patients
2. Past or present treatment with intravenous aminobisphosphonates.
3. Infection , inflammation , Smokers, undergoing radiation
therapy, sinusitis
4. Pathological growth in the sinus
5. Pregnant or lactating females
6. Poor oral hygiene maintenance
7. Severe bruxism
8. Clenching habit
9. Patients not willing to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluation of Stability of Implants , crestal bone loss, apical bone gain after Implant Placement  Evaluation of Stability of Implants at baseline, 6 months ,9months,crestal bone loss and apical bone gain after 6 months and 9 months after Implant Placement 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of Implant Stability ,Crestal Bone Loss & Apical
Bone Gain after Implants placement  
comparison of Implant Stability at baseline, 6 months & 9 months ,Crestal Bone Loss
& Apical
Bone Gain after 6 months & 9 months after Implants placement  
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   21/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Partially, edentulous patients have a problem managing with a conventional prosthesis as they may hinder comfort, aesthetics, and speech.Placing dental implants in the posterior maxillary spaces is a challenging procedure due to maxillary sinus pneumatization which may be physiologic or caused by extraction of teeth  Also vertical bone loss after extraction is a major complicating factor which results in decreased vertical bone height.The bone in the posterior maxilla is soft and poorly organized so, to increase stability of dental implant in the posterior maxilla, adequate length should be used., for which maxillary sinus floor elevation is needed in these situations..Primary Stability of dental implant is an important factor in the success rate and healing of bone around dental implant (osseointegration).Surgical sinus floor augmentation can increase the ridge height by approximately 3-5 mm, facilitating simultaneous implant placement . The conventional sinus lift techniques made use of standard drilling protocol with burs for preparing the site for implant placement.Osseodensification is a recent innovation that has the added benefits of preserving bone during osteotomy preparation, increasing the primary stability of the implant, which in turn helps in better osseointegration and success of the implant.The procedure is characterized by low plastic deformation of bone that is created by rolling and sliding contact using a densifying bur that is fluted such that it densifies the bone with minimal heat elevation and allow for bone preservation and condensation through compaction autografting during osteotomy preparation, thereby increasing the bone density in the peri-implant areas and improving the implant mechanical stability.Despite the fact that there have been numerous studies on sinus membrane elevation ,the application of minimally invasive techniques /approaches has not been thoroughly documented. Not many human studies are available in literature where a comparison has been made between CAS KIT and the new technique of Osseodensification by Densah bur.Thus, this study aims to establish a comparison and highlight the merit (if any) of any one technique.
Primary Hypothesis::Is there any difference in the Implant stability, Crestal Bone Loss and Apical Bone Gain around Implants placed by two techniques: viz Crestal Approach Sinus kit and Osseodensification by Densah Bur for Indirect Sinus Lift
Null hypothesis:There is no significant difference in the Implant Stability ,Crestal Bone Loss and Apical Bone Gain around Implants Placed using Crestal approach sinus kit and Osseodensification technique by Densah Burs for Indirect Sinus lift procedure .

 
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