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CTRI Number  CTRI/2026/02/104961 [Registered on: 26/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Bone Gain After Sinus Lift Surgery Done With And Without Using Low Crystalline Apatite Resorbable Bone Graft Material (LCR) For Dental Implant Placement 
Scientific Title of Study   Evaluation And Comparison Of Bone Volume Gain After Sinus Floor Augmentation With And Without Using Low Crystalline Apatite Resorbable (LCR) Graft For Placement Of Implant: A Randomized Controlled Trial. 
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 Maitreyi Limaye 
Designation  Post-graduate student 
Affiliation  KAHERs KLE VK Institute of Dental Sciences, Belagavi 
Address  Department of Periodontics KAHERs KLE VK Institute of Dental Sciences Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9307349636  
Fax    
Email  maitreyilimaye@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinayak R Kumbhojkar 
Designation  Professor 
Affiliation  KAHERs KLE VK Institute of Dental Sciences, Belagavi 
Address  Department of Periodontics KAHERs KLE VK Institute of Dental Sciences Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9307349636  
Fax    
Email  kumvin@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maitreyi Limaye 
Designation  Post-graduate student 
Affiliation  KAHERs KLE VK Institute of Dental Sciences, Belagavi 
Address  Department of Periodontics KAHERs KLE VK Institute of Dental Sciences Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9307349636  
Fax    
Email  maitreyilimaye@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Maitreyi Limaye 
Address  KAHERs KLE VK Institute of Dental Sciences Belagavi 
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 Maitreyi Limaye  KAHERs KLE VK Institute of Dental Sciences Belagavi  Department of Implantology
Belgaum
KARNATAKA 
09307349636

maitreyilimaye@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethical Committee KLE VKIDS NECRBHR, DHR  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  Transcrestal hydraulic lift with Low Crystalline Apatite Resorbable (LCR) Graft  Patients will undergo transcrestal hydraulic sinus floor elevation using the CAS kit (Osstem India Pvt. Ltd.) under local anesthesia. Following elevation of the Schneiderian membrane using hydraulic pressure with sterile saline, a minimum of 0.25 cc of Low Crystalline Apatite Resorbable (LCR) bone graft material (Osstem India Pvt. Ltd.) will be placed into the elevated sinus cavity. Platelet-Rich Fibrin (PRF) will be inserted prior to graft placement. Simultaneous dental implant placement will be performed as per standard protocol. Flap closure will be done using 4-0 polyamide sutures. Post-operative care will be provided as per institutional guidelines. 
Comparator Agent  Transcrestal hydraulic sinus lift without graft material  Patients will undergo transcrestal hydraulic sinus floor elevation using the CAS kit (Osstem India Pvt. Ltd.) under local anesthesia. The Schneiderian membrane will be elevated using hydraulic pressure with sterile saline only. No graft material will be placed into the sinus cavity. Simultaneous dental implant placement will be performed as per standard protocol. Flap closure and post-operative management will be identical to the intervention group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with minimal residual bone height of greater than or equal to 5mm in maxillary posterior region
and patients with adequate alveolar bone width in maxillary posterior region. 
 
ExclusionCriteria 
Details  • Patients having systemic conditions and bone disorders affecting implant surgical treatment outcomes.
• Patient with sinus pathology such as polyps and mucosal cyst and anatomical constraint like complex septa, aberrant location of PSA neurovascular bundle.
• Patients with acute and chronic sinusitis, allergic rhinitis and sinusitis or any inflammatory disorders of maxillary sinus.
• Patients having history of previous sinus surgery.
• History of radiation to head and neck area.
• Patients using immunosuppressive agents.
• Patients who have received antibiotics or anti-inflammatory drugs in the past 3 months.
• Current and past smokers.
• Poor oral hygiene.
• Severe bruxism or clenching.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Bone volume gain (vertical bone height) in the augmented sinus region  Baseline (Pre-operative)

6 months post-surgery (RVG assessment)

9 months post-surgery (CBCT assessment) 
 
Secondary Outcome  
Outcome  TimePoints 
Implant stability and survival rate  Immediately post-operative (Primary stability – intraoperative torque value)

6 months post-surgery

9 months post-surgery 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/05/2026 
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 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  

Rehabilitation of the posterior maxilla with dental implants is often limited by reduced residual bone height due to maxillary sinus pneumatization. Transcrestal hydraulic sinus lift is a minimally invasive technique used to elevate the Schneiderian membrane and promote bone formation. While graftless approaches have shown predictable results, the additional regenerative benefit of synthetic bone graft materials remains unclear. Low Crystalline Apatite Resorbable (LCR) graft is a novel synthetic bone substitute designed to mimic the crystallinity of natural bone and promote controlled resorption and new bone formation. This clinical trial aims to evaluate and compare bone volume gain following sinus floor augmentation performed with transcrestal hydraulic lift alone and with LCR graft placement during simultaneous implant insertion. A total of 30 patients will be randomly allocated into two groups (n=15 each). Radiographic assessment of vertical bone height will be performed at baseline, 6 months, and 9 months using RVG and CBCT. The study seeks to determine whether the addition of LCR graft provides superior bone volume gain compared to graftless hydraulic sinus elevation, thereby optimizing minimally invasive sinus augmentation protocols for implant placement.

 
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