| CTRI Number |
CTRI/2025/02/080136 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of different pulpotomy agents used in Primary molars |
|
Scientific Title of Study
|
A Comparative clinico-radiographic evaluation of efficacy of different pulpotomy agents used in Primary molars - A Randomised 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 Akanksha Sirohi |
| Designation |
Post graduate student |
| Affiliation |
Subharti dental college and hospital |
| Address |
Room no.3, First floor, Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital, Swami Vivekanand Subharti University
Meerut UTTAR PRADESH 250005 India |
| Phone |
9717961084 |
| Fax |
|
| Email |
dr.akanksha2201@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Noopur Kaushik |
| Designation |
Professor, Department of Pediatric and Preventive Dentistry |
| Affiliation |
Subharti dental college and hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital,Swami Vivekanand Subharti University
Meerut UTTAR PRADESH 250005 India |
| Phone |
7830008899 |
| Fax |
|
| Email |
drnoopurkaushik@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Noopur Kaushik |
| Designation |
Professor, Department of Pediatric and Preventive Dentistry |
| Affiliation |
Subharti dental college and hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital,Swami Vivekanand Subharti University
Meerut UTTAR PRADESH 250005 India |
| Phone |
7830008899 |
| Fax |
|
| Email |
drnoopurkaushik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry,Subharti dental college and hospital, Swami Vivekanand Subharti University,NH58, Delhi-Haridwar Bypass road, Meerut, Uttarpradesh, India PIN code- 250005 |
|
|
Primary Sponsor
|
| Name |
Dr Akanksha Sirohi |
| Address |
Room no. 3, First floor, Department of Pediatric and Preventive dentistry, Subharti dental college and hospital,Swami Vivekanand Subharti University, NH58, Delhi Haridwar bypass road, Meerut, Uttarpradesh, India PIN code-250005 |
| 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 Akanksha Sirohi |
Subharti dental college and hospital |
Room no. 3, First floor, Department of Pediatric and Preventive dentistry Meerut UTTAR PRADESH |
9717961084
dr.akanksha2201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient requiring vital pulpal therapy (pulpotomy) with stainless steel crown |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biodentine as pulpotomy agent on primary teeth (Group III) |
After anaesthetising the tooth, Access opening will be done. The coronal pulp will be removed, sterile moist cotton pellets applied to pulp stumps for 5 min to achieve hemostasis.
1.5-2 mm thick layer of Biodentine cement is placed in the pulp chamber.
After placing zinc oxide eugenol base, pulpotomised teeth will be restored with GIC cement followed by stainless steel crown. |
| Intervention |
Emdogain as pulpotomy agent on primary teeth (Group IV) |
After anaesthetising the tooth, Access opening will be done. The coronal pulp will be removed, sterile moist cotton pellets applied to pulp stumps for 5 min to achieve hemostasis.
A single drop of Emdogain is placed in the pulp chamber.
After placing zinc oxide eugenol base pulpotomised teeth will be restored with GIC cement followed by stainless steel crown. |
| Comparator Agent |
Laser as pulpotomy agent on primary teeth (Group I) |
After anaesthetising the tooth, Access opening will be done. The coronal pulp will be removed, sterile moist cotton pellets applied to pulp stumps for 5 min to achieve hemostasis.
Then Diode laser beam of 980 nm wavelength, 3W power is projected in continuous pulse mode for 2-3 minutes at one spot.
After placing zinc oxide eugenol base pulpotomised teeth will be restored with GIC cement followed by stainless steel crown. |
| Intervention |
MTA putty as pulpotomy agent on primary teeth (Group II) |
After anaesthetising the tooth, Access opening will be done. The coronal pulp will be removed, sterile moist cotton pellets applied to pulp stumps for 5 min to achieve hemostasis.
2mm thick layer of premixed MTA is dispensed into the pulp chamber via MTA syringe.
After placing zinc oxide eugenol base pulpotomised teeth will be restored with GIC cement followed by stainless steel crown. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Cooperative healthy pediatric patient aged 4-10 years
2. Presence of carious primary molar/ traumatic exposure / mechanical exposure during caries excavation
3. Restorable crown structure present
4. Presence of atleast 2/3rd root length
5. Bright red hemorrhage from exposure sites that can be controlled during pulpotomy procedure
6. No interradicular bone loss and radiolucency |
|
| ExclusionCriteria |
| Details |
1. Uncooperative patient
2. Medically compromised children
3. Teeth with clinical sign and symptoms of pulpal exposure with persistent pain
4. Primary teeth with root resorption more than 2/3rd of the root length
5. A non restorable teeth
6. Teeth with radiographic sign and symptoms of pulp degeneration,
pathologic mobility, swelling or/and fistula, external or internal
resorption and calcification of pulp |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate Occasional pain, Sensitivity (TOP), Fistula, Pathological mobility; Radiolucency at furcation, Internal/ external resorption, and Calcification in pulpotomised tooth. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate Occasional pain, Sensitivity (TOP), Fistula, Pathological mobility; Radiolucency at furcation, Internal/ external resorption, and Calcification in pulpotomised tooth. |
3, 6, 9 months |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
15/02/2025 |
| 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="1" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Preserving primary teeth is a key goal in pediatric dentistry, especially in the context of Early Childhood Caries (ECC) and Traumatic Dental Injuries (TDI), both of which are prevalent globally, including in India. ECC affects 49.6% of children in India, while TDI occurs in 13% of children, with higher rates in those under 6 years old. If untreated, both conditions can lead to early pulp exposure, necessitating costly and complex treatments like endodontic therapy.
To manage pulp exposure, techniques like pulpotomy are commonly used. Pulpotomy involves removing the coronal pulp to preserve the vitality of the root portion, typically in cases of extensive caries or trauma without radicular pathology. Over the years, various materials have been used for pulpotomy, including formocresol, zinc oxide eugenol (ZOE), mineral trioxide aggregate (MTA), biodentine (BD), enamel matrix derivative (Emdogain), and laser therapy.
Formocresol was historically used but is no longer recommended due to its toxicity. Alternatives like MTA and BD are popular due to their biocompatibility, sealing ability, and favorable clinical outcomes. BD, in particular, offers advantages like quick setting time and ease of handling over MTA. Emdogain, a newer material, shows promise in regenerating tooth tissues and enhancing periodontal attachment, though research is limited.
Lasers, specifically diode lasers, are also being explored for pulpotomy, as they allow precise tissue removal with minimal impact on surrounding dental structures. Despite the variety of materials and techniques, few studies have directly compared their clinical and radiographic success, making this area an important focus for future research. |