| CTRI Number |
CTRI/2025/09/095248 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post-extraction hemostasis feracrylum pressure pack Vs absorbable gelatin sponge pressure pack |
|
Scientific Title of Study
|
Comparison of post-extraction hemostasis in 4-12-year-old children using pressure pack with absorbable gelatin sponge or feracrylum- A 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 Nikita Khachane |
| Designation |
Post graduate student (Department of Pediatric and Preventive Dentistry) |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College & Hospital Navi Mumbai |
| Address |
Department of Pediatric and Preventive Dentistry Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7
CBD Belapur Navi Mumbai
Raigarh
MAHARASHTRA
400614
India |
| Phone |
9820462231 |
| Fax |
|
| Email |
khachanenikita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Jawdekar |
| Designation |
Guide and Head of Department of Pediatric and Preventive Dentistry |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College & Hospital Navi Mumbai |
| Address |
Department of Pediatric and Preventive Dentistry Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7
CBD Belapur Navi Mumbai
Raigarh
MAHARASHTRA
400614
India |
| Phone |
9821009615 |
| Fax |
|
| Email |
ashwin.jawdekar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Khachane |
| Designation |
Post graduate student (Department of Pediatric and Preventive Dentistry) |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College & Hospital Navi Mumbai |
| Address |
Department of Pediatric and Preventive Dentistry Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7
CBD Belapur Navi Mumbai
Raigarh
MAHARASHTRA
400614
India |
| Phone |
9820462231 |
| Fax |
|
| Email |
khachanenikita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sector 7 CBD Belapur
Navi Mumbai 400614 |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Khachane |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital
Sector 7 CBD Belapur Navi Mumbai 400614 |
| 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 Nikita Khachane |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital |
Bharati Vidyapeeth (Deemed
to be University) Dental
College & Hospital Sector 7
CBD Belapur Navi Mumbai
Department of Pediatric and
Preventive Dentistry
Raigarh
MAHARASHTRA |
9820462231
khachanenikita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Otherwise healthy children visiting the department of paediatric and
preventive dentistry OPD requiring routine dental treatment. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Absorbable gelatin sponge pressure pack (AGS) |
In one group, absorbable gelatin sponge will be placed under pressure pack and held by the operator for first ten minutes after extraction |
| Comparator Agent |
Feracrylum
pressure pack (FPP) |
In other group, the feracrylum impregnated pressure pack will be held at extraction site by the operator for first ten minutes after extraction |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. 4 to 12 year old otherwise healthy children.
2. Children requiring routine dental extractions such as due to caries or trauma or for orthodontic purpose of primary teeth.
|
|
| ExclusionCriteria |
| Details |
1. Children with systemic illness having any impact on blood profile
2. Children under medication that can alter coagulation profile
3. Children requiring surgical extraction, extraction with the use of elevators
4. Children requiring extraction of permanent teeth
5. Children with Grade 3 mobile teeth
6. Rootless teeth
7. Children whose parents do not provide consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-extraction haemostasis |
Post-extraction haemostasis will be assessed at the following time points. At
T0 (Immediately post-extraction) At T1 (10 minutes post-extraction) At T2 (30
minutes post-extraction) At T3 (45 minutes post-extraction) At T4 (24 hours post-extraction) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Harms (if any). |
In a 24 hour post-extraction follow-up, harms assessed include bleeding, pain,
swelling, & infection to ensure proper healing. Overall healing progress are also
monitored. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 3 |
|
Date of First Enrollment (India)
|
21/11/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 trial is underway, to be completed by May 31, 2026. |