| CTRI Number |
CTRI/2025/03/082567 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two implant surgery techniques, in patients with missing teeth with low bone height. |
|
Scientific Title of Study
|
Assessment of implant stability and bone volume around apex of implants using three different Osteotome techniques for Indirect Sinus lift procedures. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHILPA DANDEKERI |
| Designation |
Additional Professor |
| Affiliation |
NITTE Deemed to be University |
| Address |
Department of Prosthodontics,A B Shetty Memorial Institute of Dental Sciences NitteDU,Derlakatte, Mangaluru.Karnataka,India.575018
Department of Prosthodontics,A B Shetty Memorial Institute of Dental Sciences NitteDU,Derlakatte, Mangaluru.Karnataka,India.575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9008150986 |
| Fax |
|
| Email |
drshilpadandekeri@nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
MANOJ SHETTY |
| Designation |
Professor and Head of department |
| Affiliation |
NITTE DU |
| Address |
Department of Prosthodontics,A B Shetty Memorial Institute of Dental Sciences NitteDU,Derlakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
5750018
India |
| Phone |
9845267087 |
| Fax |
|
| Email |
drmanojshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANOJ SHETTY |
| Designation |
Professor and Head of department |
| Affiliation |
NITTE DU |
| Address |
Department of Prosthodontics,A B Shetty Memorial Institute of Dental Sciences NitteDU,Derlakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
5750018
India |
| Phone |
9845267087 |
| Fax |
|
| Email |
drmanojshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| A B Shetty Memorial Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Shilpa Dandekeri |
| Address |
Room Number 12,Department of Oral implantologyA B Shetty Memorial Institute of Dental Sciences NitteDU,Derlakatte, Mangaluru, Karnataka 575018 |
| 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 |
| DrShilpa Dandekeri |
NITTE Deemed to be University |
Department of Prosthodontics,ABShetty Memorial Institute of Dental Sciences,Mangaluru
Dakshina Kannada
KARNATAKA |
9008150986
drshilpadandekeri@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NITTE CENTRAL ETHICS COMMITTEE |
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 |
| Intervention |
Oral implants in posterior maxillary arch |
1.Ten patients in Osseodensification (intervention group)
2.Ten patients in Summers Osteotomy with PRF group
(intervention group)
For a duration of 12 months
|
| Comparator Agent |
oral implants in posterior maxillary arch. |
Ten patients in Summers osteotome (control group
For a duration of 12 months
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient requiring implant treatment in the maxillary arch(D3 ,D4 BONE)
2.Patient with medial and lateral sinus floor angle of more than 30 degree.
3.Patients at least 25years old, providing consent for documentation and public presentation of their clinical data.
4.Patients with fair Oral health Index.
|
|
| ExclusionCriteria |
| Details |
1.Patients with uncontrolled diabetes, recent 2.Cardiac surgery,patients on bisphophanates
3.Patients with bleeding disorders
4.Serum glycated haemoglobin more than7.0
5.Patient with poor oral hygiene index scoresless4
6.Patients with vertigo
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rehabilitation of patients with good function and esthetics |
4years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better quality of life |
20years |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/04/2025 |
| 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="5"
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
|
This is a randomized control trail where in patients will be
assigned to one of three groups : Fifteen patients
in Summers osteotome
(control group) Fifteen
patients in Osseodensification (intervention group) Fifteen patients in Summers Osteotomy with PRF group (intervention group)
For
all groups, pre-operative extra-oral photograph with panoramic radiograph for
initial screening will be taken.
Impressions for upper and lower arches will be recorded and then face bow transfer will be accomplished. Prosthetic wax-up
fabrication and pre-surgical stent will be performed for evaluation of implant placement. Moreover, for each
patient, CBCT(FOV) will be performed after sinus lifting procedure (T0) and 4 months postoperatively (T1) and
4 months postoperatively (T2). Data will be acquired by standardizing CBCT(FOV) parameters (10 mA, 12 kVp, 0.4 voxel
size). For analysis, Planmeca Romexis software version 4.6.2.R. will be used. |