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CTRI Number  CTRI/2024/02/062321 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 01/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Effect of artificial bone Substitute on firmness of Dental Implants 
Scientific Title of Study   NIL 
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 sattyam Wankhade 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur
Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  9423421428  
Fax    
Email  drsvw6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr sattyam Wankhade 
Designation  Associate Professor 
Affiliation  Government Dental College, Nagpur 
Address  Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur
Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  9423421428  
Fax    
Email  drsvw6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr sattyam Wankhade 
Designation  Associate Professor 
Affiliation  Government Dental College, Nagpur 
Address  Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur
Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  9423421428  
Fax    
Email  drsvw6@gmail.com  
 
Source of Monetary or Material Support  
Self Funded, Department of Prosthodontics, Government Dental College and Hospital, Nagpur 
 
Primary Sponsor  
Name  Dr Sattyam Wankhade 
Address  Department of Prosthodontics, Government Dental College and Hospital, Nagpur 
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 Sattyam Wankhade  Government Dental College and Hospital, Nagpur  Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur 440003
Nagpur
MAHARASHTRA 
9423421428

drsvw6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VYWS Dental College and Hospital, Amravati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteers with missing maxillary molars requiring indirect sinus lift procedure. 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autograft, Xenograft and bone putty materials.  Lifting of sinus membrane with indirect sinus lift procedure and placing of Autograft, Xenograft and bone putty material mixture to maintain the lift of the membrane. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Age more than 18 years
2.Maxillary posterior edentulous area
3.Good oral hygiene
4.Healed edentulous area for atleast 6 month- 6mm height and 5mm width
5.Patients providing due informed consent
 
 
ExclusionCriteria 
Details  •Medically compromised (Diabetetic, Hyperthyrodisim, Epilectic etc)
•Carcinoma
•Pregnant
•Smokers
•Chronic alcoholic
•Poor oral hygiene
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Increase in bone level support and stability of implant  baseline, six months and nine months 
 
Secondary Outcome  
Outcome  TimePoints 
Amount of bone graft resorption  Six 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 4 
Date of First Enrollment (India)   26/02/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The application of Dental implants for the prosthetic rehabilitation of missing teeth has provided a multitude of treatment options for patients. Loss of teeth in posterior maxillary area can lead to adverse consequences. Maxillary sinus pneumatisation is one of these that precludes placement of implants due to anatomical constraints. In this anatomical situation, it can be very difficult to obtain effective primary stability. Maxillary sinus augmentation has been shown to be a predictable method to increase posterior maxillary bone height, and allow placing dental implants when the residual alveolar ridge is deficient in bone volume. Following post extraction resorption amounting to deficient bone volume in posterior maxilla, many approaches have been described to augment the residual bone ridge by ensuring sinus membrane elevation up to 5mm without tearing it. Boyne and James first described the sinus lift technique based on a modification of the Caldwell-Luc sinus revision, involving a lateral approach to the sinus that allows a remarkable bone augumentation upto >10mm even in atrophic ridges.

This STUDY Evaluates the effect of grafting materials on implant stability and bone regeneration in patients with transcrestal approach for sinus augmentation at three different time intervals- An Experimental study

 
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