CTRI/2026/04/108076Not yet recruitingPhase 4
Radiographic Evaluation of Obturation Quality in Mandibular Second Primary Molar Using Kedo Z-Plus, Metapex and Endoflas- An In-Vivo Randomized Controlled Trial
Somya Seth1 site in 1 country60 target enrollmentStarted: April 20, 2026Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 7.00 Year(s) (—)
- Sex
- All
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
- •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.
Investigators
Somya Seth
Saveetha Dental College and Hospitals
Study Sites (1)
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