A study comparing the time taken and pain after using different file techniques (hand, rotary, and special rotary) for cleaning primary molar teeth in children aged 6 to 8 years

Comparative evaluation of the instrumentation time and post-operative pain of hand file, rotary file and controlled memory rotary file techniques in biomechanical preparation of primary molars: A randomized controlled clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092913

Enrollment

Registered

2025-08-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: A409- Streptococcal sepsis, unspecified

Interventions

Intervention1: Rotary files: Cleaning and shaping of primary molars will be done using rotary files (conventional NiTi rotary system). Utilization of pediatric rotary files, for biomechanical preparat

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 to 8 years with at least one mandibular primary molar requiring pulpectomy Primary mandibular molars with asymptomatic irreversible pulpitis with a minimum of two third of root length remaining. Preoperative radiograph revealing absence of periapical lesion or interradicular radiolucency. Children who are cooperative and able to sit through treatment procedures. Parental or guardian consent and child assent obtained for participation in the study.

Exclusion criteria

Exclusion criteria: Patient with any systemic diseases or disabilities or incompetent to understand instructions Patient with history of taking analgesics 12 hour before and after the pulpectomy procedure. Teeth with internal or external root resorption extending beyond one-third of the root. Teeth with pathological mobility or advanced periodontal involvement. Presence of periapical or furcal radiolucency exceeding 5 mm. History of acute dental pain or abscess within the past 48 hours. Teeth previously treated endodontically or with open apex. Children with a known allergy to local anesthetics or endodontic materials. Uncooperative behavior making it difficult to complete the procedure under routine clinical settings.

Design outcomes

Primary

Measure	Time frame
time of instrumentation and postopertaive pain with rotary and control memory rotaryTimepoint: instrumrntation time and postoperative pain at an interval of 6 24 48 72 hour	—

Secondary

Measure	Time frame
Behavioral response of the child Postoperative analgesic consumption incidence of intraoperative complicationsTimepoint: instrumentation time postoperative pain analgesic consumption at an interval of 6 24 48 72 hour	—

Countries

India

Contacts

Public ContactNikita Kishor Jakhotiya

Pacific Dental College And Hospital

pedodinesh2003@yahoo.co.in9414158235

Outcome results

None listed

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