| CTRI Number |
CTRI/2025/08/093102 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In children, when there is pain due to pulp involvement, the success rate between pulpotomy treatment and pulpectomy treatment will be compared. |
|
Scientific Title of Study
|
Treatment effectiveness of pulpotomy as compared to pulpectomy for management of symptomatic irreversible pulpitis in primary teeth: 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 |
Hitesh Chander |
| Designation |
Associate professor |
| Affiliation |
ESIC dental college and hospital Kalaburagi |
| Address |
Department of Pediatric Dentistry, ESIC Dental College & Hospital, Sedam road, Kalaburagi, Karnataka
Gulbarga
KARNATAKA
585101
India |
| Phone |
8607707755 |
| Fax |
|
| Email |
dr.hiteshmittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hitesh Chander |
| Designation |
Associate professor |
| Affiliation |
ESIC dental college and hospital Kalaburagi |
| Address |
Department of Pediatric Dentistry, ESIC Dental College & Hospital, Sedam road, Kalaburagi, Karnataka
KARNATAKA
585101
India |
| Phone |
8607707755 |
| Fax |
|
| Email |
dr.hiteshmittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hitesh Chander |
| Designation |
Associate professor |
| Affiliation |
ESIC dental college and hospital Kalaburagi |
| Address |
Department of Pediatric Dentistry, ESIC Dental College & Hospital, Sedam road, Kalaburagi, Karnataka
KARNATAKA
585101
India |
| Phone |
8607707755 |
| Fax |
|
| Email |
dr.hiteshmittal@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC dental College & Hospital,Sedam road, Kalaburagi, Karanataka, India. Pincode 585106 |
|
|
Primary Sponsor
|
| Name |
ESIC dental College and Hospital |
| Address |
Sedam Road, kalaburagi |
| Type of Sponsor |
Other [Government Dental College and Hospital] |
|
|
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 Hitesh Chander |
ESIC Dental college |
Department of Pediatric Dentistry, ESIC Dental College & Hospital, Sedam road, Kalaburagi, Karnataka
Gulbarga
KARNATAKA |
08607707755
dr.hiteshmittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-ESIC DENTAL COLLEGE, KALABURAGI |
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 |
The pulpectomy procedure will adhere to standard clinical procedural guidelines.
The pulpectomy procedure will be performed using Metapex (Iodoform and calcium hydroxide paste) as obturating material for pulpectomy procedure will be used.
All the treatment teeth will be restored with a layer of GIC followed by composite restoration. All the teeth will receive SSC over the treated teeth after a period of one week. Standard post-operative instructions for pulpectomy treatment groups will be advised to patients.
|
| Intervention |
Pulpotomy |
The pulpotomy will adhere to standard clinical procedural guidelines.
The bio-dentine material will be used as pulp medicament for pulpotomy.
All the treatment teeth will be restored with a layer of GIC followed by composite restoration. All the teeth will receive SSC over the treated teeth after a period of one week. Standard post-operative instructions for pulpotomy treatment groups will be advised to patients.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children with carious teeth between the ages of 4 to 10 years will be invited to participate in the study
inclusion criteria:
(i) symptoms typical of irreversible pulpitis
(ii) the primary molar is restorable with stainless steel crown; and
(iii) iv) any physiologic root resorption, if present, is less than 1/3 the normal root length.
|
|
| ExclusionCriteria |
| Details |
exclusion criteria:
(i) clinical sign/symptoms of pathologic tooth mobility, parulis/fistula, or soft tissue swelling;
(ii) preoperative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area;
(iii) pre-operative periapical radiograph suggests presence of periapical radiolucency/pathological root resorption
(iv) Intra-operatively, visual examination of pulp tissue reveals signs of necrosis i.e., avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical and radiographic outcomes will be assessed independently by two trained, calibrated examiners and shall be blinded to the treatment or follow up time interval.
Clinical success of the treated tooth will be determined based on no clinical symptoms of pain/tenderness on percussion/ parulis/fistula/soft tissue swelling/pathological mobility etc.
Radiographic success will be determined by no signs of pathological changes. |
3 months 6 months 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Survival analysis will be calculated for the two procedures for the follow up period. |
one year |
| Pre-operative and post-operative pain intensity will be assessed using the Visual Analogue Scale. |
at 24 h and 7 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
23/08/2025 |
| 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="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
|
This parallel, two-armed, non-inferiority
randomized controlled trial will be conducted as per CONSORT guidelines.
A total of 100 primary teeth diagnosed with
irreversible pulpitis will be recruited for the study in 100 children aged 4 to
10 years. The interventions (pulpotomy and pulpectomy) will be randomly allocated to children meeting inclusion criteria in ratio of 1:1 using sequentially numbered opaque sealed envelopes of varied length
blocks. The researcher performing the procedure will be blinded to the block
sizes and the randomization sequence. The bio-dentine material will be used as
pulp medicament for pulpotomy and Metapex (Iodoform and calcium hydroxide
paste) as obturating material for pulpectomy procedure and standard clinical
procedural guidelines will be used. All
the treatment teeth will be restored finally restored with composite
restoration and SSC.
Pre-operative and
post-operative pain intensity will be assessed using the Visual Analogue Scale.
All the teeth receiving the two interventions will be evaluated for clinical
and radiographic outcomes by two independently, trained, calibrated and blinded
(for time duration) examiners at 24 hrs, 7 days, 3 months, 6 months and one
year follow up duration. Survival analysis will be calculated for the two
procedures for the follow up period. |