| CTRI Number |
CTRI/2024/05/066679 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To check for bone level around implant placed after sinus lift procedure. |
|
Scientific Title of Study
|
Evaluation of new bone formation in sinus floor augmentation using collagen plug impregnated with injectable platelet rich fibrin- A single blinded randomized controlled 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 |
Debotri Basu |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no:6,1st floor, Department of Oral and Maxillofacial Surgery, Sri Ramachandra Faculties of Dental Sciences, SRIHER, No. 1, Ramachandra Nagar,Porur, Chennai,Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
7980405922 |
| Fax |
|
| Email |
debotri.basu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. J Nanveen Kumar |
| Designation |
Head of the department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no:6,1st floor, Department of Oral and Maxillofacial Surgery, Sri Ramachandra Faculties of Dental Sciences, SRIHER, No. 1, Ramachandra Nagar,Porur, Chennai,Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840069012 |
| Fax |
|
| Email |
naveenkumarj@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Debotri Basu |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no:6,1st floor, Department of Oral and Maxillofacial Surgery, Sri Ramachandra Faculties of Dental Sciences, SRIHER, No. 1, Ramachandra Nagar,Porur, Chennai,Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
7980405922 |
| Fax |
|
| Email |
debotri.basu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and maxillofacial surgery, Sri ramachandra dental college and hospital, SRIHER |
|
|
Primary Sponsor
|
| Name |
Debotri Basu |
| Address |
Room no:6,1st floor, Department of Oral and Maxillofacial Surgery, Sri Ramachandra Faculties of Dental Sciences, SRIHER, No. 1, Ramachandra Nagar ,Porur,Chennai,Tamil Nadu 600116 |
| Type of Sponsor |
Other [Not applicable ] |
|
|
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 Debotri |
Sri Ramachandra Institute of Higher Education and Research |
Room no:6,1st floor, Department of Oral and Maxillofacial Surgery, Sri Ramachandra Faculties of Dental Sciences, SRIHER, No. 1, Ramachandra Nagar ,Porur,Chennai,Tamil Nadu 600116
Chennai
TAMIL NADU |
7980405922
debotri.basu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No medical history |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Elevated sinus cavity filled with Blood coagulum |
Blood coagulum is natural blood clot which plays a role in healing
|
| Intervention |
Elevated sinus cavity filled with Injectable PRF (i-PRF) impregnated in collagen plug |
Injectable PRF (i-PRF) is a novel PRF matrix derivative that is obtained from venous blood in low centrifugation forces and short centrifugation durations. i-PRF comprises a wide range of growth factors and inflammatory cells that play pivotal role in tissue regeneration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with missing maxillary posterior teeth and consenting to receive implant restoration.
2.Patients with good oral hygiene and no dental or periodontal diseases that might affect postoperative healing.
3.Patients above the age of 18 years.
|
|
| ExclusionCriteria |
| Details |
1.Patients with prominent sinus pathology.
2.Severe (non-correctable) deformities of the maxillary sinus.
3.Scarred and hypofunctional sinus mucosa following trauma of previous operation.
4.Radiotherapy of head and neck region.
5.Pregnant women
6.Medically compromised individuals.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| peri-implant bone formed |
Baseline,
3 months post-operative
6 months post-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Role of i-PRF in bone regeneration in sinus augmenation.
The role of natural blood clot in bone regeneration post sinus floor augmentation procedure. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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 - NO
|
|
Brief Summary
|
Patients will be selected as per the mentioned inclusion and exclusion criteria. Pre-operative CBCT will be taken to evaluate available bone for implant placement. Pre-operative planning of implant size is done. Informed consent will be obtained and patients will be randomly allocated in either study and control group. Necessary intervention will be performed as per group pre-requisites. In the study group sinus augmentation is done with placement of i-PRF soaked collagen plug and simultaneous immediate implant placement. In the control group sinus augmentation and immediate implant placement is done without placement of any graft material. Hemostasis will be achieved. Post-operative instructions shall be given to the patient with necessary medications. Patients will be recalled at 3 months and 6 months Post-operatively for clinical follow-up and postoperative CBCT
|