| CTRI Number |
CTRI/2020/02/023443 [Registered on: 19/02/2020] Trial Registered Prospectively |
| Last Modified On: |
23/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
periapical healing evaluation after root end surgery with different retro filling materials with or without platelet rich fibrin |
|
Scientific Title of Study
|
Evaluation of Periapical Healing after Endodontic Microsurgery Using Different Retrograde Filling Materials With or Without Platelet Rich Fibrin - An In Vivo Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
SGT University |
| Address |
Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University, Budhera, Gurugram-Badli Road, Gurugram Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8867901392 |
| Fax |
|
| Email |
vipulgupta12d3268@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep S Grewal |
| Designation |
Head of the department |
| Affiliation |
SGT University |
| Address |
Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University, Budhera, Gurugram-Badli Road, Gurugram Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9810805880 |
| Fax |
|
| Email |
drmandeepsgrewal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipul Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
SGT University |
| Address |
Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University, Budhera, Gurugram-Badli Road, Gurugram Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8867901392 |
| Fax |
|
| Email |
vipulgupta12d3268@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vipul Gupta |
| Address |
Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University, Budhera Gurugram Badli Road Gurugram 122505 Haryana |
| 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 |
| Dr Vipul Gupta |
Faculty of Dental Sciences SGT University Gurugram Haryana |
Department of Conservative Dentistry and Endodontics Budhera Gurugram Badli Road Gurugram 122505 Haryana
Gurgaon
HARYANA |
8867901392
vipulgupta12d3268@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Ritu Duggal, Dr Mandeep S Grewal, Dr Anil Gupta, Dr. Poonam Salvan, Mr Dinesh, Mr Azad Singh, Mr Sachinder Chauhan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
endodontic lesions not responding to conventional root canal treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MTA
Biodentine
PRF |
retrograde filling will be done using MTA and Biodentine individually and in combination with PRF
pre operative and post operative CBCT will be evaluated |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Endodontic lesions not responding to conventional root canal treatments
2.Non-contributory medical history (ASA class I and class II)
3.Lesion involving 1-3 roots
4.Overfilled canals
5.Separated instrument in the apical half
6.Ledge formation or transportation in the canal
7.Anatomically complex root canal configurations |
|
| ExclusionCriteria |
| Details |
1.Medically compromised patient (ASA class III to class VI)
2.Fractured tooth
3.Periodontally compromised patients
4.Through and through defects
5.Close Proximity to critical anatomical structures |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The purpose of this study is the Evaluation of periapical healing of the lesion after an endodontic microsurgery with different retrograde filling materials, with or without Platelet Rich Fibrin (PRF) autologous material. |
1 week
3 months
6 months
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The purpose of this study is the Evaluation of periapical healing of the lesion after an endodontic microsurgery with different retrograde filling materials, with or without Platelet Rich Fibrin |
1 week
3 months
6 months
12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2020 |
| Date of Study Completion (India) |
21/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is the Evaluation of periapical healing of the lesion after an endodontic microsurgery with different retrograde filling materials, with or without Platelet Rich Fibrin (PRF) autologous material. Total of 60 subjects with lesion not responding to conventional root canal treatment will be selected and endodontic microsurgery will be done. Retrograde root preparation will be done and subjects will be randomly divided into 4 groups of 15 members each based on the root end filling materials. Different retrograde filling materials(MTA, Biodentine) will be used with or without platelet rich fibrin. wound healing will be evaluated radiographically by measuring the volume of the lesion using CBCT after 12 months post operation. |