| CTRI Number |
CTRI/2025/08/092971 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of use of PRF apical plug with conventional root canal treatment on periradicular tissue healing |
|
Scientific Title of Study
|
Comparative evaluation of the effect of conventional root canal treatment with PRF apical plug versus without on periradicular tissues healing: A randomized clinical 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 |
Dr Aakash Gupta |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
Room Number 3028, Ground Floor, C-Block, AIIMS; Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
09877939523 |
| Fax |
|
| Email |
guptaaakash95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aakash Gupta |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
Room Number 3028, Ground Floor, C-Block, AIIMS; Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
09877939523 |
| Fax |
|
| Email |
guptaaakash95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aakash Gupta |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
Room Number 3028, Ground Floor, C-Block, AIIMS; Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
09877939523 |
| Fax |
|
| Email |
guptaaakash95@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bathinda, Punjab, India- 151001 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bathinda |
| Address |
Jodhpur Romana, Mandi Dabwali Road, Bathinda, Punjab-151001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aakash Gupta |
AIIMS Bathinda |
Division of Conservative Dentistry and Endodontics, Department of Dentistry, Jodhpur Romana, Mandi Dabwali Road, Bathinda, Punjab-151001
Bathinda
PUNJAB |
09877939523
guptaaakash95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K042||Pulp degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet Rich Fibrin with root canal treatment |
Platelet Rich Fibrin will be placed as apical plug in cases with periradicular pathology undergoing root canal treatment |
| Comparator Agent |
Root canal treatment |
Conventional root canal treatment without PRF apical plug will be compared with 6 months follow up |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients with periradicular pathology and indicated for root canal treatment.
Permanent mandibular molars
patients willing for written informed consent and follow up visits |
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic diseases like diabetes mellitus, osteoporosis
Patients with poor periodontal health and tooth mobility
Patients with mandibular molars used as an abutment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Platelet rich fibrin apical plug on healing of periradicular tissues in cases of periradicular pathology |
To evaluate the effect of Platelet rich fibrin apical plug on healing of periradicular tissues in cases of periradicular pathology at 1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
25/08/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Root Canal Treatment is a complex procedure aimed at preserving the tooth in oral cavity in terms of form, function and aesthetics. However, in cases of periradicular pathologies and big periapical lesions, healing of periradicular tissues is affected. This study was planned to evaluate the effect of Platelet rich fibrin (PRF) apical plug placed inside root canal with conventional root canal treatment on healing of periradicular tissues versus patients undergoing conventional root canal treatment without any PRF apical plug |