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Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars

NCT07319741 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-01-06

No results posted yet for this study

Summary

This study will evaluate the clinical and radiographic outcomes of rotary versus manual pulpectomy in children with irreversible pulpitis.A single-visit pulpectomy will be performed for all patients. Participants will be allocated to rotary instrumentation using Fanta AF Baby files or manual step-back instrumentation with K-files. Canals will be irrigated with 17% EDTA and 1% sodium hypochlorite, obturated with Metapex, and restored with glass ionomer cement and stainless-steel crowns. Primary outcomes will assess clinical success at 3, 6, 9, and 12 months, while secondary outcomes will evaluate postoperative pain and radiographic success at 6 and 12 months.

Conditions

  • Pulpectomy
  • Irreversible Pulpitis

Interventions

PROCEDURE

Rotary Instrumentation

Single visit pulpectomy using rotary instrumentation

PROCEDURE

Manual Instrumentation

Single visit pulpectomy using manual instrumentation

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Anfal mohamed elmotaz almogtaba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319741 on ClinicalTrials.gov