| CTRI Number |
CTRI/2025/03/081640 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check whether the dental implant placed in the upper back teeth region is strong after placing with different material |
|
Scientific Title of Study
|
Comparative evaluation of the effects of injectable-platelet rich fibrin (I-PRF) and synthetic graft on the implant stability following indirect sinus augmentation |
| 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 Sunaina M |
| Designation |
Post-Graduate student |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Prosthodontics, room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9901179680 |
| Fax |
|
| Email |
sunainam048@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mallikarjuna R |
| Designation |
Reader, Guide |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Prosthodontics, room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7676708707 |
| Fax |
|
| Email |
ragher@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunaina M |
| Designation |
Post-Graduate student |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Prosthodontics, room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9901179680 |
| Fax |
|
| Email |
sunainam048@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics, room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangalore, 575018 |
|
|
Primary Sponsor
|
| Name |
Dr Sunaina M |
| Address |
#1-118(7), Sanna Madaka House, Amblamogaru Post, Mangalore, Dakshina Kannada, Karnataka, India -575017 |
| Type of Sponsor |
Other [self funding] |
|
|
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 Sunaina M |
YENEPOYA DENTAL COLLEGE |
Department of Prosthodontics, room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA |
9901179680
sunainam048@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| yenepoya ethics committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indirect Sinus Augmentation |
Indirect Sinus Augmentation using Injectable Platelet Rich Fibrin (I-PRF), Synthetic Graft and without Graft
Total duration 6 months |
| Comparator Agent |
Indirect Sinus Augmentation. |
Comparative evaluation of the effects of Injectable-Platelet Rich Fibrin (I-PRF) and Synthetic Graft on the Implant Stability following Indirect Sinus Augmentation.
Total duration 6 months |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be selected using the following criteria:
1. Healed edentulous ridge in the maxillary pre-molar or molar region.
2. Residual bone height ranging from 4 to 6 mm.
3. Crestal bone width ranging from 6 to 8 mm.
4. Maintaining Good oral hygiene
|
|
| ExclusionCriteria |
| Details |
1. Systemic conditions such as uncontrolled diabetes mellitus, hypertension and bleeding disorder
2. Presence of active sinusitis
3. Sinus membrane thickening of more than 2mm
4. Patients on long term steroid therapy or bisphosphonate medication
5. Any previous history of sinus surgery
6. Untreated active periodontitis in neighbouring teeth
7. Participants who are current smokers
8. Pregnant women and nursing mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the implant stability following indirect sinus augmentation using Injectable-Platelet Rich Fibrin (I-PRF), synthetic graft and without graft |
at baseleine, at 6 months after implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the stability of the implant following indirect sinus augmentation using Injectable-Platelet Rich Fibrin (I-PRF), synthetic graft & without bone graft. |
At baseline & after 6 months after implant placement |
|
|
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 4 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="2"
Months="1"
Days="15" |
|
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 study aims to assess and compare the effects of Injectable-Platelet-Rich Fibrin
(I-PRF) and synthetic graft on the implant stability following indirect
sinus augmentation. The study will include 30 participants with missing maxillary posterior teeth and a minimum of 4mm residual
bone height and 6mm crestal bone width. Participants will be divided into 3 groups of 10 each. In
Group 1, participants will undergo sinus membrane elevation without graft. For
Group 2, participants will undergo sinus membrane elevation and Injectable-Platelet
Rich Fibrin (I-PRF) will be used for augmentation. In Group 3, participants
will undergo sinus membrane elevation and synthetic graft material will be used
for augmentation. Appropriate implant will be selected and placed depending on
the parameters of the participant’s native bone. Implant stability will be
measured using resonance frequency analysis (RFA) device at the time of implant
placement and at 6 months. The
values will be noted in the data collection sheet. Statistical analysis will be
done accordingly and obtained data will be used to find the association between 3
groups. |