| CTRI Number |
CTRI/2026/02/103340 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
28/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study Comparing Two Dental Treatments for Infected Primary Teeth in Children |
|
Scientific Title of Study
|
Comparative evaluation of non-instrumentation pulp therapy using calcium silicate-based cements versus conventional method for irreversible pulpitis in deciduous molars: a randomized clinical study |
| 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 swasti joshi |
| Designation |
post graduate student |
| Affiliation |
Karnavati School of Dentistry |
| Address |
A 907, Karnavati University,Block B, Department of Pediatric and Preventive Dentistry, Adalaj Uvarsad Road 382422
Gandhinagar
GUJARAT
382422
India |
| Phone |
7567260866 |
| Fax |
|
| Email |
199swastijoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya Patel |
| Designation |
Professor |
| Affiliation |
Karnavati School of Dentistry |
| Address |
A 907, Karnavati University,Block B, Department of Pediatric and Preventive Dentistry, Adalaj Uvarsad Road 382422
Gandhinagar
GUJARAT
382422
India |
| Phone |
9638215549 |
| Fax |
|
| Email |
dr.chhayachildcare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaya Patel |
| Designation |
Professor |
| Affiliation |
Karnavati School of Dentistry |
| Address |
A 907, Karnavati University,Block B, Department of Pediatric and Preventive Dentistry, Adalaj Uvarsad Road 382422
Gandhinagar
GUJARAT
382422
India |
| Phone |
9638215549 |
| Fax |
|
| Email |
dr.chhayachildcare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnavati School of Dentistry
A-907 Uvarsad-Adalaj Road Gandhinagar 382422 |
|
|
Primary Sponsor
|
| Name |
Dr Swasti Joshi |
| Address |
B/22 Sanskruti Complex behind Tejas School Bopal Ahmedabad Gujarat 380058 |
| 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 Swasti Joshi |
Karnavati School of Dentistry |
A 907, Karnavati University,Block B, Department of Pediatric and Preventive Dentistry, Adalaj Uvarsad Road 382422
Gandhinagar
GUJARAT |
7567260866
199swastijoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnavati School of Dentistry Ethics Committe |
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 |
| Comparator Agent |
pulpectomy (instrumentation) in primary molars with irreversible pulpitis |
pulpectomy (instrumentation) followed by stainless steel crown placement in primary molars with irreversible pulpitis: duration 6 months |
| Intervention |
pulpotomy (non-instrumentation) in primary molars with irreversible pulpitis |
pulpotomy (non-instrumentation) followed by stainless steel crown placement in primary molars with irreversible pulpitis: duration 6 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children belonging to age group 5-9 years.
2. Frankl’s scale positive and definitely positive
3. Symptoms typical of irreversible pulpitis i.e., spontaneous unprovoked pain lasting few seconds to several hours in the days before the dental visit or pain that is exacerbated by hot and/or cold stimuli with the pain lingering even after removal of stimuli
4. No clinical symptom or evidence of periapical or furcal radiolucency
5. Restorable teeth
6. Children who agreed to participate and also obtained written consent from their parents/guardians.
|
|
| ExclusionCriteria |
| Details |
1. Children suffering from any mental or systemic illness
2. Children with frankl’s scale negative and definitely negative
3. Children with dental emergencies, such as trauma.
4. Clinical examination reveals signs of pulpal infection i.e., pathologic tooth mobility, parulis/fistula, or soft tissue swelling
5. Preoperative periapical radiograph suggests presence of furcal radiolucency more than half the furcation to periapical area
6. Patients/ parents/ legal guardians who refuse to give consent
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the clinical success of the treatment at the follow up visit on 1, 3, 6 months
2. To assess radiographical success of the treatment at the follow up visit on 1, 3, 6 months
3. To assess the efficacy of calcium silicate based cement and standard pulpectomy obturating material in deciduous molars diagnosed with irreversible pulpitis
|
0-pre treatment
1-immediate post treatment
2-after 1 month of treatment
3-after 3 months of treatment
4-after 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To evaluate pain post operatively after 3 days and 7 days of intervention by Wong Baker Faces pain scale |
0-pre treatment wong baker scale
1-post treatment
2- after 03 days of treatment
3- after 07 days of treatment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/02/2026 |
| Date of Study Completion (India) |
30/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
American Association of Endodontists (AAE) Consensus Conference Recommended Diagnostic Terminology defines irreversible pulpitis as a clinical diagnosis based on subjective and objective findings indicating that the vital inflamed pulp is incapable of healing. Pulpitis can be managed with different treatment options such as direct pulp capping, pulpotomy, or root canal treatment.
The primary goal of pulp therapy is to maintain the integrity and health of the teeth and their supporting tissues while maintaining the vitality of the pulp of a tooth affected by caries, traumatic injury, or other causes. A pulpectomy is indicated in a primary tooth with irreversible pulpitis or necrosis or a tooth treatment planned for pulpotomy in which the radicular pulp exhibits clinical signs of irreversible pulpitis (eg, excessive hemorrhage that is not controlled with a damp cotton pellet applied for several minutes) or pulp necrosis (eg, suppration, purulence). The roots should exhibit minimal or no resorption.Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis.
A pulpotomy is performed in a primary tooth with extensive caries but without evidence of radicular pathology when caries removal results in a carious or mechanical pulp exposure.The coronal pulp is amputed whereas the remaining vital radicular pulp tissue surface is treated with a long-term clinically successful medicament such as Buckley’s Solution of formocresol or ferric sulfate.
The recent decade has seen a paradigm shift in the treatment concepts of how vital mature permanent molars diagnosed with irreversible pulpitis can be more conservatively managed using vital pulp therapy techniques like pulpotomy. The ribbon-like torturous root canal anatomy in primary molars makes pulpectomy a difficult procedure for general dentists to perform, often requires a child in pain to be referred to a specialist paediatric dentist for definitive treatment. Pulpotomy has gained popularity as an alternative treatment option to pulpectomy due to its advantages, such as reduced chair time, lower cost, and better preservation of tooth structure.
Due to the limited number of studies and clinical trials evaluating pulpotomy for irreversible pulpitis in primary molars, this study will be undertaken to explore its potential as a viable treatment option.
The null hypothesis is that there will be no significant difference in treatment outcomes of the non-instrumentation intervention pulp therapy and conventional pulpectomy treatment for deciduous molar diagnosed with irreversible pulpitis |