| CTRI Number |
CTRI/2024/03/063461 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the bone gain after placement of Hydroxyapetitite bone graft and Titanium induced platelet rich fibrin in extraction socket |
|
Scientific Title of Study
|
Evaluation of Effectiveness of Nano-crystalline Hydroxyapatite Bone Graft in combination with Titanium-Platelet Rich Fibrin (T-PRF) for Ridge Preservation: A Clinical and Radiographic study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchita Patil |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and research |
| Address |
Datta Meghe Institute of Higher Education and research Sharad Pawar Dental College Sawangi Meghe
Sharad Pawar Dental College
Wardha
MAHARASHTRA
442001
India |
| Phone |
09406309740 |
| Fax |
1 |
| Email |
struchita27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasad V Dhadse |
| Designation |
Head of the Department |
| Affiliation |
Datta Meghe Institute of Higher Education and research |
| Address |
Datta Meghe Institute of Higher Education and research Sharad Pawar Dental College
Sharad Pawar Dental College
Wardha
MAHARASHTRA
442001
India |
| Phone |
09406309740 |
| Fax |
1 |
| Email |
drprasaddhadse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchita Patil |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and research |
| Address |
Datta Meghe Institute of Higher Education and research Sharad Pawar Dental College
Sharad Pawar Dental College
Wardha
MAHARASHTRA
442001
India |
| Phone |
09406309740 |
| Fax |
1 |
| Email |
struchita27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College, Sawangi (Meghe), Wardha |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Datta Meghe Institute of Higher Education and research Sharad Pawar Dental College Sawangi Meghe |
| Type of Sponsor |
Research institution |
|
|
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 Ruchita Tejrao Patil |
SPDC, Department of Periodontics |
Department number 3, Department of Periodontics, Datta Meghe Institute of Higher Education and research Sharad Pawar Dental College Sawangi Meghe
Wardha
MAHARASHTRA |
9406309740
1
struchita27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
| Institutional Ethical Committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
3. Presence of grossly decayed tooth/teeth or root piece without the presence of purulent exudate or cellulitis. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
at baseline |
Nanocrystalline Hydroappetite Bone Grft & Titanium Platelet Rich Fibrin (T-PRF) at 3 months after surgery |
| Intervention |
Hydroxyapetitie bone graft with T-PRF |
Nanocrystalline Hydroappetite Bone Grft & Titanium Platelet Rich Fibrin (T-PRF) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically Healthy individual with grossly decayed tooth or root piece without cellulities. |
|
| ExclusionCriteria |
| Details |
1.Patients not adhering for continuance of periodontal maintenance programme.
2.A habit of smoking or consuming tobacco.
3.Any earlier or previous periodontal regeneration procedures performed into chosen location or site.
4.Females who are pregnant or nursing.
5.Patients having a history of systemic illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Height of ridge the ridge will be measured from the cement-enamel junction (CEJ) of adjacent teeth to occlusal surface of the adjacent teeth.
The width of the ridge will be bacco-lingually using an UNC-15 calibrated periodontal probe (University of North Carolina, Hu-Friedy).
|
At Baseline and after 3 months of Surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic bone fill will be assist using Cone Beam Computed Tomography (CBCT) at baseline and after 6 months. |
6 months. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Nanocrystalline Hydroappetite Bone Grft & Titanium Platelet Rich Fibrin (T-PRF) will be placed in extraction socket for ridge preservation after atraumatic extraction and will be evaluated at baseline and after 3 months |