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CTRI Number  CTRI/2024/07/070681 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the primary and delayed stability of dental implants using lateral window approach & crestal approach by hydraulic lift. 
Scientific Title of Study   Comparative evaluation of stability of dental implants placed in inadequate height maxillary posterior region using two different sinus lift techniques- An in vivo 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  Dr Sushree Bishnupriya 
Designation  MDS (Postgraduate) 
Affiliation  ITS Dental College Hospital And Research Centre 
Address  Department of Prosthodontics and Crown and Bridge, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9556006567  
Fax    
Email  sushreebishnupriya2023@its.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditya Chaudhary 
Designation  Professor 
Affiliation  ITS Dental College Hospital And Research Centre 
Address  Department of Prosthodontics and Crown and Bridge, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9868911499  
Fax    
Email  adityachaudharyy@its.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Aditya Chaudhary 
Designation  Professor 
Affiliation  ITS Dental College Hospital And Research Centre 
Address  Department of Prosthodontics and Crown and Bridge, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9868911499  
Fax    
Email  adityachaudharyy@its.edu.in  
 
Source of Monetary or Material Support  
Department of Prosthodontics and Crown and Bridge, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India 
 
Primary Sponsor  
Name  ITS Dental College Hospital And Research Centre 
Address  Department of Prosthodontics and Crown and Bridge, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India 
Type of Sponsor  Research institution and hospital 
 
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 Sushree Bishnupriya  ITS Dental College Hospital and Research Centre, Greater Noida  Department of Prosthodontics and Crown and Bridge, ITS Dental College Hospital And Research Centre, 47, Knowledge Park III, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India
Gautam Buddha Nagar
UTTAR PRADESH 		 9556006567

sushreebishnupriya2023@its.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ITS Dental College Hospital and Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K063||Horizontal alveolar bone loss,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Implant placement by crestal approach  10 dental implants would be placed by this technique using bone graft. Primary and Delayed stability will be evaluated. 
Intervention  Implant placement by lateral window approach  10 dental implants would be placed by this technique using bone graft. Primary and Delayed stability will be evaluated. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Partially edentulous maxilla patients with residual alveolar crest of ≤5mm in height.
Age-more than 20 years.
Presence of at least one intact adjacent tooth.
Good oral hygiene and satisfactory periodontal status of remaining dentition.
 
 
ExclusionCriteria 
Details 
Subjected to irradiation in the head and neck area less than 1 one year before implantation.
Any systemic disease contraindicating implant placement.
Uncontrolled diabetes, osteoporosis, hypertension etc.
Bleeding disorders.
Psychosis or Psychiatric disorders.
Pregnant or lactating women.
Acute or Chronic recurrent sinusitis.
Lack of opposite occluding dentition or prosthesis in the area intended for implant placement.
Severe bruxism or clenching.
Smokers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Evaluation of primary stability in dental implants placed in inadequate height maxillary posterior region using lateral window approach.

2) Evaluation of primary stability in dental implants placed in inadequate height maxillary posterior region using crestal approach by hydraulic lift.

3) Evaluation of delayed stability after 1 year, in dental implants placed in inadequate height maxillary posterior region using lateral window approach.

4) Evaluation of delayed stability after 1 year, in dental implants placed in inadequate height maxillary posterior region using crestal approach by hydraulic lift.
 		 At 6 months and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Comparative evaluation of primary stability in dental implants placed in inadequate height maxillary posterior region using lateral window approach and crestal approach.

2) Comparative evaluation of delayed stability after 1 year, in dental implants placed in inadequate height maxillary posterior region by lateral window approach & crestal approach.
 		 At 6 months & 12 months. 
 
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   N/A 
Date of First Enrollment (India)   26/07/2024 
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="1"
Months="6"
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   This study will be conducted to compare the primary and delayed stability of dental implants placed in inadequate height maxillary posterior region using later window approach and crestal approach by hydraulic lift. Total number of 20 dental implants will be placed randomly by two different methods in accordance with inclusion and exclusion criteria. Patients with residual alveolar bone of less than or equal to 5mm height in maxillary posterior region will be included in the study. The implants will be placed by two different techniques- lateral window approach and crestal approach by hydraulic lift. Primary stability will be recorded with the help of Resonance Frequency Analysis and Insertion torque values. All patients will be prescribed with standard antibiotic and anti-inflammatory protocol. 
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