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Comparison of obturation quality and root canal treatment time between Neolix and M3 Immatural rotary systems and hand instrument in primary mandibular molars

Comparison of obturation quality and root canal treatment time between Neolix and M3 Immatural rotary systems and hand instrument in primary mandibular molars: a single blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221120056551N1
Enrollment
30
Registered
2023-02-13
Start date
2023-01-21
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Necrosis of pulp. Necrosis of pulp

Interventions

Intervention 1: Intervention group: Root canal instrumentation will be done using M3 Immatural (#20) rotary files. Intervention 2: Control group: Root canal preparation will be done using Hand K-files

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 9 Years

Inclusion criteria

Inclusion criteria: Age 4 to 9 years. Vital or necrotic mandibular primary molars without sinus tract. Absence of internal or external pathological root resorption. At least two-thirds of remaining root length. Children exhibiting Frankl's behavior rating scale score of 3 and 4. Presence of adequate coronal tooth structure to receive Stainless Steel (SS) crown or amalgam restoration. Signature of consent form.

Exclusion criteria

Exclusion criteria: Children with underlying systemic diseases and those with special healthcare needs. Children lacking cooperative ability. Teeth with more than one-third of pathological root resorption. Radiolucent area(s) in the radiography. Teeth that cannot be restored.

Design outcomes

Primary

MeasureTime frame
Obturation quality. Timepoint: Immediately after root canal obturation. Method of measurement: The obturation quality will be graded as optimal fill, overfill, and underfill (by Coll JA and Sadrian R 1996).;Treatment time. Timepoint: Time to prepare and obturate the root canal. Method of measurement: by stopwatch.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Abasirostami

Babol University of Medical Sciences

mo.abbasi@mubabol.ac.ir0098 11 2291408

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026