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CTRI Number  CTRI/2024/07/069719 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Two-Year Study on Clinical and CBCT Outcomes of Indirect Sinus Lift Procedure Without Bone Graft Material in Patients Missing Upper Back Teet 
Scientific Title of Study   Clinical and cbct evaluation of indirect sinus lift procedure without using bone graft material in maxillary posterior edentulous patients- a 2-year prospective 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 Purushottam Rakhewar 
Designation  Professor and hod 
Affiliation  SMBT dental college and hospital 
Address  G-02 Department of Periodontics SMBT Dental college and hospital amrutnagar Sangamner Ahmadnagar MAHARASHTRA 422608 India

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9370017343  
Fax    
Email  drpsrakhewar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Purushottam Rakhewar 
Designation  Professor and hod 
Affiliation  SMBT dental college and hospital 
Address  G-02 Department of Periodontics SMBT Dental college and hospital amrutnagar Sangamner Ahmadnagar MAHARASHTRA 422608 India

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9370017343  
Fax    
Email  drpsrakhewar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Purushottam Rakhewar 
Designation  Professor and hod 
Affiliation  SMBT dental college and hospital 
Address  G-02 Department of Periodontics SMBT Dental college and hospital amrutnagar Sangamner Ahmadnagar MAHARASHTRA 422608 India

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9370017343  
Fax    
Email  drpsrakhewar@gmail.com  
 
Source of Monetary or Material Support  
SMBT Dental college and Hospital,amrutnagar,sangamner-422608 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [none] 
 
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 Purushottam Rakhewar  SMBT Dental college and hospital  G-02 Department of Periodontics Sangamner
Ahmadnagar
MAHARASHTRA 
9370017343

drpsrakhewar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Commitee on Ethics, SMBT Dental College,Sangamner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  to perform the indirect sinus lift procedure without bone graft material in partially edentulous patients requiring implant treatment in the posterior maxilla   indirect sinus lift procedure will be performed in partially edentulous patients without using bone graft and simultaneously osstem implants will be placed in the posterior maxilla. All patients will have an initial baseline examination of clinical and radiographic parameters and then measurements will be taken immediately at stage 1 surgery, stage 2 surgery, 6 months and 1 year and 2 year follow up. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1] patients that require implant treatment in the posterior maxilla.
2] Patients requiring indirect sinus lift procedure without bone grafting.
3] residual bone height (RBH) should be ≤8 mm on mesial or distal implant side.
4] Patients with age group 18 years or older, and able to understand and sign a written informed
consent form
5] Both male and female
6] Absence of any local anatomical limitations
7] Patient willing for surgery 
 
ExclusionCriteria 
Details  1] Medical history indicating acute or chronic sinusitis
2] Presence of active periodontal disease, diabetes, or metabolic bone disease
3] Insufficient primary implant stability
4] General contraindications to implant surgery
5] Local and systemic conditions affecting bone
6] Poor oral hygiene and motivation
7] Unable to commit to 2-year follow-up
8] Treated or under treatment with intravenous amino-bisphosphonates
9] Lacking antagonistic occlusal surfaces for the study implants at implant loading. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
the long-term outcomes of implants placed in the edentulous posterior maxilla using sinus floor
elevation without grafting. 
at baseline, at stage
2, 6 months, 1 year and 2 year interval 
 
Secondary Outcome  
Outcome  TimePoints 
to measure and analyze bone levels around these implants after sinus floor elevation without grafting  at baseline, 1 year and 2 year interval 
 
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 4 
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="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 aim of this study is to evaluate the clinical and radiographic outcomes of the indirect sinus lift procedure without bone graft material in edentulous patients requiring implant treatment in the posterior maxilla over a 2-year period.  All the participants will be explained the need and design of the study. Informed and written consent will be obtained from the patients. Thorough clinical case history will be recorded. A full mouth supragingival and subgingival scaling and root planing procedure will be performed. 2 weeks after phase I therapy, clinical evaluation and radiographic evaluation will be performed to confirm the suitability of the sites for this study. Clinical parameters like pain intensity from implant region, implant stability, modified plaque index (PI), modified sulcus bleeding index (mBI), probing pocket depth and width of masticatory mucosa (Wma) will be measured and radiographic parameters like RBH (residual bone height) at implant placement, peri-implant sinus bone levels, implant protrusion into the sinus and peri-implant crestal bone levels will be evaluated. Intraoral antisepsis will be performed with 0.2% chlorhexidine digluconate rinse and an iodine solution will be used to carry out extra oral antisepsis. After administration of local anaesthesia, horizontal crestal incision following, mucoperiosteal flaps will be reflected. To perform indirect sinus lift using CAS kit, first twist drill with appropriate size stopper will be used to reach 2mm short of the sinus floor. After this, CAS drills will be used sequentially till the implant size is reached using the same stopper. The goal will be to widen the osteotomy till the desired implant size. After performing the osteotomy, we will start going deeper by changing the stopper sequentially in 1mm increments till the drop into the sinus floor is felt. Depth gauge will be used to check if the sinus floor has been reached. The membrane will now be lifted using the hydraulic lift system provided. Saline will be used to aid in the lifting procedure. A suitable size OSSTEM implant body will be placed with the help of a rachet. The implant body will be covered by cover screw. The mucoperiosteal flaps will be repositioned and secured in place using non-absorbable black silk surgical suture. The interrupted suture will be placed. At Stage 2 – cover screw will be removed and healing abutment will be placed (4 months after stage 1 surgery). 1 month after stage 2 surgery impression will be taken for crown prosthesis and crown will be delivered soon after it is prepared. All implants placement will be done by single trained surgeon at stage 1 and stage 2 surgery. In postoperative care antibiotics like amoxcillin 500mg tid for 5 days and analgesic diclofenac sodium 50mg + paracetamol 500mg tid for 5 days will be prescribed, along with chlorhexidine digluconate rinse twice daily for 2 weeks. Sutures will be removed after 10 days postoperatively. Each patient will be reinstructed for proper oral hygiene measures at each appointment, and re-examined at 6 months, 1 year and 2 year. Soft and hard tissue evaluation will be performed at at stage 1 surgery, stage 2 surgery, 6 months,1 year and 2 year follow up. For hard tissue re-evaluation, CBCT of the same study site will be carried out.

 
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