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Comparison of Three Root Canal Filling Materials in Children s Lower Back Milk Teeth Based on X-ray Quality

Radiographic Evaluation of Obturation Quality in Mandibular Second Primary Molar Using Kedo Z-Plus, Metapex and Endoflas- An In-Vivo Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108076
Enrollment
60
Registered
2026-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K049- Other and unspecified diseases ofpulp and periapical tissues

Interventions

Intervention1: Kedo Z-Plus.: Root canal obturation performed using Kedo Z-Plus paste delivered through a syringe system following standardized canal preparation. Control Intervention1: Metapex: Root c

Sponsors

Somya Seth
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Radiographic assessment of the quality of root canal obturation in treated mandibular second primary molars.Timepoint: Immediately after obturation

Secondary

MeasureTime frame
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.Timepoint: Immediately after obturation

Countries

India

Contacts

Public ContactSomya Seth

Saveetha Dental College and Hospitals

helloganz@gmail.com9884293869

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026