| CTRI Number |
CTRI/2026/01/102638 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Root canal cleaning solutions used in milk teeth of children. |
|
Scientific Title of Study
|
Comparative antimicrobial efficacy and clinical success of saline, chlorhexidine, one percent sodium hypochlorite and MTAD as intracanal irrigants in primary molar pulpectomy A randomised controlled 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 |
Khushi Parmar |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College and Hospitals , Chennai |
| Address |
Clinic 28 , Department of Pediatric and Preventive Dentistry , Saveetha Dental College and Hospital 162, Poonamallee High Road, Velappanchavadi, Chennai , Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
8805978579 |
| Fax |
|
| Email |
parmarkhushi2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ramesh R |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals , Chennai |
| Address |
Clinic 28 , Department of Pediatric and Preventive Dentistry , Saveetha Dental College and Hospital 162, Poonamallee High Road, Velappanchavadi, Chennai , Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Parmar |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College and Hospitals , Chennai |
| Address |
Clinic 28 , Department of Pediatric and Preventive Dentistry , Saveetha Dental College and Hospital 162, Poonamallee High Road, Velappanchavadi, Chennai , Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
8805978579 |
| Fax |
|
| Email |
parmarkhushi2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital 162, Poonamallee High Road, Velappanchavadi, Chennai Tamil Nadu 600077 |
|
|
Primary Sponsor
|
| Name |
Khushi Parmar |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry,Saveetha Dental College and Hospitals 162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| 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 Khushi Parmar |
Saveetha Dental College and Hospital |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital, 162, Poonamallee High Road, Velappanchavadi, Chennai Tamil Nadu 600077
Chennai
TAMIL NADU |
8805978579
parmarkhushi2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children requiring primary molar pulpectomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine irrigation |
Pulpectomy will be performed in primary molars under rubber dam isolation. Biomechanical preparation will be carried out using hand and rotary files. Irrigation will be done using two percent chlorhexidine solution delivered through a side vented irrigation needle. A standardised volume will be used in all cases. |
| Comparator Agent |
MTAD Irrigation |
Pulpectomy will be performed in primary molars under rubber dam isolation. Biomechanical preparation will be carried out using hand and rotary files. Irrigation will be done using MTAD solution delivered through a side vented irrigation needle as final irrigant. A standardised volume will be used in all cases. |
| Intervention |
Normal Saline irrigation |
Pulpectomy will be performed in primary molars under rubber dam isolation. Biomechanical preparation will be carried out using hand and rotary files. Irrigation will be done using normal saline solution delivered through a side vented irrigation needle. A standardised volume will be used in all cases. |
| Comparator Agent |
One percent sodium hypochlorite irrigation |
Pulpectomy will be performed in primary molars under rubber dam isolation. Biomechanical preparation will be done using hand and rotary files.
Irrigation will be done using one percent sodium hypochlorite solution delivered through a side vented irrigation needle. A standardised volume will be used in all cases. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children aged four to nine years of age
Primary molars indicated for pulpectomy
Teeth with minimum two thirds root length remaining
Physiological root resorption not exceeding one third of root length
Restorable primary molars with adequate coronal structure
Written informed consent from parent or guardian |
|
| ExclusionCriteria |
| Details |
Children with systemic illness affecting healing or immunity.
History of allergy to saline, chlorhexidine, sodium hypochlorite or MTAD
Teeth with pathological root resorption, root perforation non restorable crown structure, excessive mobility, extensive furcal bone loss
Previously endodontically treated teeth
Children on antibiotics within past two or four weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in intracanal bacterial load, assessed by microbiological analysis of root canal samples collected before irrigation and immediately after final irrigation using sterlie papaer points. |
Before and after irrigation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical success of pulpectomy at three and six months defined by the absence of spontaneous pain, swelling,sinus tract, tenderness to percussion or pathological mobility |
clinical success at three months and six months |
| Radiographic success at three and six months determined by absence or reduction of furcal or periapical radiolucency, no evidence of pathological root resorption and normal development of the permanent successor . |
Radiographic success at three months and six months. |
| Post operative pain within the first seventy two hours following treatment, evaluated using age appropriate pain assessment scale. |
Seventy two hours after treatment |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
12/02/2026 |
| 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="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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 randomized controlled clinical trial compares the antimicrobial efficacy and clinical success of normal saline, chlorhexidine, one percent sodium hypochlorite, and MTAD as intracanal irrigants in primary molar pulpectomy. Children aged four to nine years will be included. The primary outcome is reduction in intracanal bacterial load. Secondary outcomes include clinical and radiographic success at three and six months, and post operative pain within seventy two hours. The planned sample size is one hundred sixty participants. |