| CTRI Number |
CTRI/2026/02/104901 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two materials used to stop bleeding during treatment of deep tooth decay in children and their success |
|
Scientific Title of Study
|
Comparative evaluation of clinical success of pulpotomy using adrenaline 1 to 1000 with 2 percent sodium hypochlorite as hemostatic agents in permanent teeth of children aged 8 to 14 years 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 |
Reny Philip |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education And Research |
| Address |
Room No 202
Oral Health Science Centre
Postgraduate Institute of Medical Education and Research Sector12
Chandigarh
PIN 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9400827566 |
| Fax |
|
| Email |
renyphilip27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Kapur |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education And Research |
| Address |
Room No 215
Oral Health Science Centre
Postgraduate Institute of Medical Education and Research Sector12
Chandigarh
PIN 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815966348 |
| Fax |
|
| Email |
draditikmalhotra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reny Philip |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education And Research |
| Address |
Room No 202
Oral Health Science Centre
Postgraduate Institute of Medical Education and Research Sector12
Chandigarh
PIN 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9400827566 |
| Fax |
|
| Email |
renyphilip27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Reny Philip |
| Address |
Room no 202
Unit of pedodontics and preventive dentistry
Oral health science center
PGIMER
Chandigarh
PIN 160012
Phone no 9400827566 |
| 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 |
| Reny Philip |
Post graduate institute of medical science and research center |
Room No 202
Unit of pedodontics and preventive dentistry
Oral Health Science Centre
Postgraduate Institute of Medical Education and Research Sector12
Chandigarh
PIN 160012
Chandigarh
CHANDIGARH |
9400827566
renyphilip27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 to 1000 Adernaline as a hemostastic agent |
Use of adrenaline (1:1000) as the hemostatic agent following coronal pulp removal during pulpotomy |
| Comparator Agent |
2 percentage Sodium hypochlorite as a hemostastic agent |
Use of 2 % sodium hypochlorite (NaOCl) as the hemostatic agent following coronal pulp removal during pulpotomy |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1 Children aged 8 to 14 years
2 Permanent anterior or posterior teeth due to trauma deep carious exposure or molar incisor hypomineralization
3 Deep caries affecting at least two-thirds of the dentine
4 Normal periapical tissues (Periapical index score less than 2)
5 A positive response to cold test
6 Ability to achieve pulpal hemostasis within 5 minutes using one of the test agents
7 Children with Frankel behaviour rating 3 or 4
|
|
| ExclusionCriteria |
| Details |
1 Tooth with draining sinus or swelling
2 Periapical radiolucency or widening of periodontal space or resorption of roots
3 Non-restorable crown
4 Patients with insufficient bleeding after pulp exposure suggestive of partial necrosis of pulp
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical success of pulpotomy using adrenaline and sodium hypochlorite as hemostatic agents in permanent teeth of children aged 8 to 14 years |
1 week,1 month,3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate radiographic changes after treatment
|
Baseline , six months |
| To evaluate & compare the time taken to achieve hemostasis using adrenaline versus sodium hypochlorite |
Baseline |
| To determine the relationship between the inflammatory marker MMP-9 in pulpal fluid & pulpotomy outcome |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="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
|
The current randomized controlled trial is planned in pulpally exposed teeth to compare clinical success of pulpotomy using 1 to 1000 adernaline and 2 percent sodium hypochlorite as hemostastic agent in permanent teeth of children aged between 8 to 14 year. The primary objective is to evaluate short term clinical success using these agents. The secondary objective is to evaluate short term radographic success, time to achieve haemostasis using both agents and to assess level of inflammatory markers in blood samples collected intraoperatively and to correlate with treatment outcomes |