| 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
|
|
|
Primary Sponsor
|
| Name |
Dr Maitreyi Limaye |
| Address |
KAHERs KLE VK Institute of Dental Sciences Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |