| CTRI Number |
CTRI/2025/03/081638 [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
|
Comparing Bone Growth in Upper Back Tooth Region Using Different Material that will Increase Bone Height |
|
Scientific Title of Study
|
Comparative Evaluation of Three-Dimensional Volumetric Bone Formation and Bone Density Following an Indirect Sinus Floor Augmentation with Injectable Platelet Rich Fibrin (I-PRF) and Alloplastic Graft Material |
| 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 Nafiya Abdul Aziz |
| Designation |
Post Graduate Student |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Prosthodontics and Crown and Bridge, Room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7795373075 |
| Fax |
|
| Email |
nafiyaabdulaziz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanath Kumar Shetty |
| Designation |
Professor, Guide |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Prosthodontics and Crown and Bridge, Room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845208322 |
| Fax |
|
| Email |
drshetty@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nafiya Abdul Aziz |
| Designation |
Post Graduate Student |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Prosthodontics and Crown and Bridge, Room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7795373075 |
| Fax |
|
| Email |
nafiyaabdulaziz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics and Crown and Bridge, Room no 2, Yenepoya Dental College, Yenepoya Deemed To Be University, University Road, Derlakatte, Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
Dr Nafiya Abdul Aziz |
| Address |
Manar House, adjacent to Canada bank ATM, near Rani Abbaka Circle, Ullal |
| Type of Sponsor |
Other [Dr Nafiya Abdul Aziz] |
|
|
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 Nafiya Abdul Aziz |
Yenepoya Dental College |
Department of Prosthodontics and Crown and Bridge, Yenepoya Dental College, Yenepoya Deemed To Be University, Derlakatte, Mangaluru
575018
Dakshina Kannada
KARNATAKA |
7795373075
nafiyaabdulaziz@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 |
| Comparator Agent |
Comparator |
Comparative Evaluation of Three-Dimensional Volumetric Bone Formation and Bone Density Following an Indirect Sinus Floor Augmentation with Injectable Platelet Rich Fibrin (I-PRF) and Alloplastic Graft Material
Total duration is 6 months |
| Intervention |
Intervention |
Evaluation of Bone Formation and Bone Density Following an Indirect Sinus Floor Augmentation with Injectable Platelet Rich Fibrin (I-PRF) and Alloplastic Graft Material
Total duration is 6 months |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with a healed alveolar ridge with missing premolar or molar in the maxilla
2. Residual bone height of 4 to 6 mm
3. Crestal bone width of 6 to 8 mm
4. 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 evaluate volumetric bone formation and bone density following indirect sinus floor augmentation using Injectable Platelet Rich Fibrin (I-PRF), alloplastic graft and with no graft material. |
Before treatment and after six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the endo-sinus bone volume and density following indirect sinus augmentation using Injectable Platelet Rich Fibrin (I-PRF), alloplastic graft and with no graft material |
Before treatment and after six months |
|
|
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
|
The aim of this study is to analyse the volume and density of the endo-sinus bone after maxillary sinus augmentation with I-PRF and alloplastic graft material using cone beam computed tomography (CBCT) scan after 6 months. The study will include 30 participants within the age range of 19-60 years, who are willing to undergo implant placement for the rehabilitation of missing teeth in the deficient posterior maxilla and have a residual bone height and width of 4-6 mm and 6-8 mm, respectively. Participants will be informed about the details of the study, and a participant information sheet and informed consent form will be signed by them prior to the study. All the surgical procedure will be carried out by a single trained clinician. Appropriate implant will be selected and placed depending on the participant’s native bone, including width and height. Once the data is obtained, it will be used to compare the endo-sinus bone volume and density following indirect sinus augmentation using I-PRF, alloplastic graft and with no graft material. |