| CTRI Number |
CTRI/2026/04/108076 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Randomized Control Trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Three Root Canal Filling Materials in Children’s Lower Back Milk Teeth Based on X-ray Quality |
|
Scientific Title of Study
|
Radiographic Evaluation of Obturation Quality in Mandibular Second Primary Molar Using Kedo Z-Plus, Metapex and Endoflas- An In-Vivo 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 |
Somya Seth |
| Designation |
Postgraduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7597698819 |
| Fax |
|
| Email |
sdc.ssomya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh J |
| Designation |
Professor, Head of Dept |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Somya Seth |
| Designation |
Postgraduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7597698819 |
| Fax |
|
| Email |
sdc.ssomya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Somya Seth |
| Address |
Saveetha Dental College And Hospitals 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, India Pin code-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 Somya Seth |
Saveetha Dental College And Hospitals |
Clinic-28,Department of Pediatric and Preventive Dentistry 162, Poonamallee High Rd, Velappanchavadi
Thiruvallur
TAMIL NADU
Thiruvallur
TAMIL NADU |
7597698819
sdc.ssomya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endoflas |
Root canal obturation performed using endoflas obturating paste placed according to manufacturer’s instructions following standardized canal preparation. |
| Intervention |
Kedo Z-Plus. |
Root canal obturation performed using Kedo Z-Plus paste delivered through a syringe system following standardized canal preparation. |
| Comparator Agent |
Metapex |
Root canal obturation performed using metapex paste delivered through a syringe system following standardized canal preparation. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 4 to 7 years.
2.Children requiring pulpectomy in at least one mandibular second primary molar.
3.Teeth diagnosed with irreversible pulpitis or necrotic pulp, indicated for pulpectomy.
4.Mandibular second primary molars with at least two-thirds of root length remaining and without advanced physiologic root resorption.
5.Teeth with restorable crowns and adequate remaining tooth structure.
6.Children with no known systemic diseases affecting healing or dental treatment.
7.Children whose parents/guardians provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Children younger than 4 years or older than 7 years.
2.Mandibular second primary molars with advanced physiologic or pathologic root resorption (more than one-third of root length).
3.Teeth with internal or external pathological resorption.
4.Teeth with non-restorable crowns, vertical root fractures, or extensive structural damage.
5.Teeth with periapical pathology involving the permanent successor tooth germ.
6.Teeth with severe root canal calcification, obliteration, or abnormal morphology preventing proper instrumentation.
7.Children with systemic illnesses, immunocompromised status, or conditions affecting wound healing.
8.Children with known allergy or hypersensitivity to any components of the obturating materials.
9.Children who are uncooperative or unable to tolerate treatment under routine clinical conditions.
10.Children who have received antibiotic therapy within the previous two weeks. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiographic assessment of the quality of root canal obturation in treated mandibular second primary molars. |
Immediately after obturation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Presence or absence of voids in the obturated root canals on immediate postoperative radiograph.
2.Extent of obturating material beyond the apex, if present, on immediate postoperative radiograph. |
Immediately after obturation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/04/2026 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized controlled clinical trial aims to compare the radiographic quality of root canal obturation in mandibular second primary molars using three different obturating materials in children aged 4 to 7years. Eligible children requiring pulpectomy will be randomly allocated into three groups. Each group will receive root canal obturation with one of the study materials following standardized clinical procedures. The primary outcome will be the radiographic assessment of obturation quality immediately after treatment. The findings of this study are expected to provide evidence on the relative effectiveness of different obturating materials in pediatric endodontic treatment. |