| CTRI Number |
CTRI/2025/02/079952 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of hemostasis achieved by different hemostatic agents for vital pulp therapy- Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparative evaluation of the effect of new hemostatic agents in vital pulp therapy- 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 |
Dr Aakash Gupta |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
Room Number 3027, Ground floor, c-block, Department of Dentistry
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 3027, Ground floor, c-block, Department of Dentistry
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 3027, Ground floor, c-block, Department of Dentistry
Bathinda
PUNJAB
151001
India |
| Phone |
09877939523 |
| Fax |
|
| Email |
guptaaakash95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aakash Gupta |
| Address |
Room Number 3027, Ground Floor, C-Block, AIIMS; Bathinda (Punjab), India- 151001 |
| 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 Aakash Gupta |
All India Institute of Medical Sciences Bathinda |
Room Number 3027, Ground floor, c-block, Department of Dentistry
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: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lignocaine with 1:80,000 adrenaline |
2% lignocaine with 1:80,000 adrenaline will be compared as a haemostatic agent in vital pulp therapy |
| Intervention |
2.5% Sodium Hypochlorite |
2.5% Sodium Hypochlorite will be used as a haemostatic agent in vital pulp therapy procedure and time required for hemostasis will be noted |
| Comparator Agent |
diode laser |
diode laser will be compared as a haemostatic agent |
| Comparator Agent |
microfibrillar collagen |
Microfibrillar collagen will be compared as a haemostatic agent |
| Comparator Agent |
Tranexamic Acid 100mg/ml |
Tranexamic acid 100mg/ml will be compared as a hemostatic agent in vital pulp therapy |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from symptomatic irreversible pulpitis
2. patient undergoing vital pulp therapy |
|
| ExclusionCriteria |
| Details |
1. Patients with acute and chronic apical abscess
2. Patients with dental trauma
3. Patients with bone or root resorption |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of efficacy of different haemostatic agents on vital pulp therapy procedure capped with biodentine |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of different haemostatic agent in achieving haemostasis in terms of duration |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="3"
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
|
This randomized controlled trial will be done to check the efficacy of different haemostatic agents after vital pulp therapy |