| CTRI Number |
CTRI/2025/10/096168 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“A study to compare how much new bone forms inside the sinus area when using or not using bone grafts during a special drilling technique (osseodensification) to raise the sinus floor for dental implants.” |
|
Scientific Title of Study
|
Clinico-radiological evaluation of endosinus bone gain with and without grafting in indirect sinus floor augmentation using osseodensification concept: 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 |
Ankita |
| Designation |
Post graduate |
| Affiliation |
Faculty of dental sciences, IMS, BHU |
| Address |
Room no-4 2nd floor Unit of Prosthodontic Faculty of Dental Sciences IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9120390058 |
| Fax |
|
| Email |
singhankita30822@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavan Dubey |
| Designation |
Professor and Guide |
| Affiliation |
Faculty of dental sciences, IMS, BHU |
| Address |
Room no- 4 2nd floor Unit of Prosthodontic Faculty of Dental Sciences IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838626666 |
| Fax |
|
| Email |
drpavan26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavan Dubey |
| Designation |
Professor and Guide |
| Affiliation |
Faculty of dental sciences, IMS, BHU |
| Address |
Room no- 4 2nd floor Unit of Prosthodontic Faculty of Dental Sciences IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838626666 |
| Fax |
|
| Email |
drpavan26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences Institute of Medical Sciences BHU Uttar Pradesh Varanasi 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Ankita |
| Address |
Room no-4 unit of ProdthodonticS and Crown and Bridge Banaras Hindu University
Uttar Pradesh
221005
Varanasi India
|
| 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 Ankita |
BHU |
Room no -4 Unit of Prosthodontics and Crown and Bridge Faculty of Dental Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
Varanasi
UTTAR PRADESH |
9120390058
singhankita30822@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute Of Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
maxillary posterior edentulous space with sinus height more than 4mm and less than 8mm |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
indirect sinus lift with xenograft in gel form |
indirect sinus lift with xenograft |
| Comparator Agent |
indirect sinus lift without use of any graft |
indirect sinus lift without use of any graft |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with missing tooth from maxillary posterior region with residual bone height
lesser than 8mm and more than 4mm
2. Patients with good oral hygiene and healthy periodontal status.
3.No acute infection is present.
4.Informed and signed consent. |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled diabetes (HBA1c greater than 7.5%)
2.Treated or under treatment with bisphosphonate for any medical illness
3.Irradiated in the head and neck area in the last 5 years
4. Pregnant or breast feeding
5.Substance abusers
6. Psychiatric problems or unrealistic expectations
7. Patient not fully able to comply with the study protocol
Local exclusion criteria consisted of the following
1.Residual bone height greater than 8mm
2. Maxillary sinus conditions contraindicating sinus floor elevation
3.Poor oral hygiene and motivation (Full Mouth Plaque Score greater than 20% and or Full Mouth
Bleeding Score greater than 10%) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Endosinus bone gain: - To measure the extent of endosinus bone gain achieved in the
grafted and non-grafted groups through CBCT |
4 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Bone density assessment: - To assess changes in bone density at the implant site
following osseodensification in both grafted and non-grafted groups using CBCT
2. Primary stability evaluation: - to evaluate and compare the primary stability of implants
placed in the sinus lift site using torque rachet |
0 DAYS |
|
|
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)
|
10/11/2025 |
| 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 in vivo study titled “Clinico-radiological evaluation of endosinus bone gain with and without grafting in indirect sinus floor augmentation using osseodensification concept” aims to compare the outcomes of sinus lift procedures performed with and without xenograft materials using the osseodensification technique. It evaluates bone density, primary implant stability, and endosinus bone gain through CBCT analysis. Twenty patients with residual bone height between 4–8 mm in the posterior maxilla will be included. The study seeks to determine whether osseodensification alone can achieve comparable bone augmentation and implant stability to that achieved with additional grafting. |