| CTRI Number |
CTRI/2026/01/100966 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Long implants with sinus lift versus short implants: which is better for missing upper back teeth? |
|
Scientific Title of Study
|
Comparative evaluation of implant stability, clinical and CBCT outcomes of long implants with indirect
sinus lift versus short implants in maxillary posterior edentulous patients – a randomized clinical 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 Janhavi Kulkarni |
| Designation |
Post graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02 Department of Periodontology, SMBT Dental College and Hospital
Ahmadnagar MAHARASHTRA 422608 India |
| Phone |
9405271999 |
| Fax |
|
| Email |
janhaviajitkulkarni@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Purushottam Rakhewar |
| Designation |
Head of Department and PG Guide |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02 Department of Periodontology, SMBT Dental College and Hospital
Ahmadnagar MAHARASHTRA 422608 India |
| Phone |
9370017343 |
| Fax |
|
| Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Janhavi Kulkarni |
| Designation |
Post graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02 Department of Periodontology, SMBT Dental College and Hospital
Ahmadnagar MAHARASHTRA 422608 India |
| Phone |
9405271999 |
| Fax |
|
| Email |
janhaviajitkulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital, Sangamner, Ahmednagar, Maharashtra, India, 422608 |
|
|
Primary Sponsor
|
| Name |
Indian Society of Periodontology |
| Address |
ISP, #721, Phase 3B-1, Mohali, India - 160059 |
| Type of Sponsor |
Other [National Professional Organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Janhavi Kulkarni |
G-02, Department of Periodontology, SMBT Dental College and Hospital, Ghulewadi, Sangamner, Ahmednagar, Maharashtra, India, 422608 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janhavi Kulkarni |
SMBT Dental College and Hospital |
G-02 Department of Periodontology, SMBT Dental College and Hospital Ahmadnagar MAHARASHTRA |
9405271999
janhaviajitkulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics, SMBT Dental College, Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Indirect sinus lift with long implants |
Following the administration of local anaesthesia, a horizontal crestal incision will be made, and mucoperiosteal flaps will be elevated. To carry out indirect sinus lift using osteotomes, pilot drill will be used to prepare the implant site to a distance approximately 2 mm below the sinus floor. The osteotomy site will be expanded with sequential drilling. After reaching the sinus floor, with light tapping osteotome will be pushed to create a greenstick fracture on the compact bone of the sinus floor. Subsequently, larger diameter osteotomes will be used at same length until desired implant size is achieved. A suitable size implant body will be placed with the help of a ratchet. The implant body will be covered by cover screw. The mucoperiosteal flaps will be repositioned and stabilized using non-absorbable black silk surgical sutures. Interrupted suture will be placed. The implant stability, clinical and CBCT changes and the resultant outcome after placement of long implants with indirect sinus lift at stage 1 surgery, stage 2 surgery, during loading and 1 year follow up and at baseline and 1 year follow up radiographically will be assessed. |
| Intervention |
Short implants |
Following the administration of local anaesthesia, a horizontal crestal incision will be made, and mucoperiosteal flaps will be elevated. Sequential osteotomy will be done and
suitable size short implant body will be placed with the help of a ratchet. The implant body will be covered by cover screw. The mucoperiosteal flaps will be repositioned and stabilized using non-absorbable black silk surgical sutures. Interrupted suture will be placed. The implant stability, clinical and CBCT changes and the resultant outcome after placement of short implants at stage 1 surgery, stage 2 surgery, during loading and 1 year follow up and at baseline and 1 year follow up radiographically will be assessed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Partially edentulous posterior maxilla,
Residual bone height of 5-7 mm with ridge width more than 6 mm,
Patients requiring indirect sinus lift,
Patients willing for surgery |
|
| ExclusionCriteria |
| Details |
General contraindications to implant surgery
o Local and systemic conditions affecting bone
o Poor oral hygiene and motivation
o Presence of local anatomical limitations
o Untreated periodontitis or acute/purulent infection in the area intended for
implant placement
o Unable to commit to 1-year follow-up
o Treated or under treatment with intravenous amino-bisphosphonates
o Lacking antagonistic occlusal surfaces for the study implants at implant loading |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Successful osseointegration
Stable, functional and long term replacement of missing tooth |
Baseline
At stage 2 surgery
During loading
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
02/02/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [janhaviajitkulkarni@gmail.com].
- For how long will this data be available start date provided 15-05-2026 and end date provided 15-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study aims to evaluate and compare implant stability, clinical and CBCT outcomes of long implants with
indirect sinus lift and short implant placement in maxillary posterior edentulous arches. The
expected outcomes include evaluating implant stability, implant survival rates, and clinical
effectiveness over a 1-year follow-up period. This information will help determine the relative
success rates in rehabilitating posterior maxillary edentulous areas thus offering evidence based
guidance in clinical decision-making. The clinical parameters will be assessed at baseline, stage 1 surgery, stage 2 surgery and 1 year follow up whereas CBCT parameters will be assessed at baseline and 1 year follow up. |