Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars

Clinical and Radiographic Evaluation of Single Visit Pulpectomy in Primary Molars for (5-7) Years Old Children Using Rotary and Manual Instrumentation: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis; Pulpectomy
• Intervention / Treatment: Procedure: Rotary Instrumentation; Procedure: Manual Instrumentation

Detailed Description

In this study, the principal investigator will screen participants to ensure eligibility and obtain comprehensive medical and dental histories from their parents or legal guardians, along with informed consent. All participants will undergo thorough clinical and radiographic examinations to confirm a diagnosis of irreversible pulpitis and suitability for pulpectomy. Local anesthesia will be administered, followed by caries removal, access cavity preparation, and pulpal extirpation. Working length will be determined radiographically, and participants will be allocated into two groups based on instrumentation technique: Group 1 will receive rotary instrumentation using Fanta AF Baby files with a crown-down approach, while Group 2 will undergo manual instrumentation using K-files with a step-back technique. Irrigation will involve 17% EDTA gel and 1% sodium hypochlorite, and canals will be obturated with Metapex, followed by restoration with glass ionomer cement and stainless-steel crowns in the same visit. The primary outcome will assess clinical success at 3, 6, 9, and 12 months post-treatment, defined by the absence of soft tissue swelling, tenderness, sinus tract, fistula, or pathological mobility. Secondary outcomes will include evaluation of postoperative pain intensity using a modified Wong-Baker Pain Rating Scale and radiographic success at 6 and 12 months, defined by the absence of root resorption, periodontal ligament widening, or periapical/furcal radiolucency.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anfal Mohammed Almogtaba, Bechlor's degree in dentistry; Phone Number: +201125202599; Email: anfal.mohamed@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11835
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged 5-7 years with irreversible pulpitis of primary molars.
• History of spontaneous pain with a deep carious lesion.
• Parents who approve to write informed consent.

Exclusion Criteria:

• Medically compromised children.
• Children with a history of allergic reaction to the materials used in the study.
• Children with non-restorable teeth.
• Teeth with resorbed roots (more than two-thirds of root length).
• Extensive internal or external root resorption visible in periapical Radiographs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Single-Visit Pulpectomy using Rotary instrumentation; This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using rotary instrumentation	Procedure: Rotary Instrumentation; Single visit pulpectomy using rotary instrumentation
Active Comparator: Group2: Single-visit pulpectomy using manual instrumentation; This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using manual instrumentation	Procedure: Manual Instrumentation; Single visit pulpectomy using manual instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success of Pulpectomy procedure	The primary outcome of this study will be the assessment of clinical success of the both instrumentation techniques (Manual and Rotary instrumentation), evaluated at 3, 6, 9, and 12 months post-treatment. Clinical success will be defined based on binary assessment by the absence of soft tissue swelling, tenderness to percussion (Performed by the back of the mirror), sinus tract, fistula, and pathologic mobility	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Radiographic Success of Pulpectomy	Another secondary outcome of this study will be the radiographic evaluation of treatment after manual and rotary instrumentation based on binary assessment at 6 and 12 months postoperatively. Radiographic success will be defined as the absence of internal or external root resorption, loss of lamina dura integrity, periodontal ligament widening, or alveolar bone resorption in the periapical region. The presence of any of these findings or periapical/furcal radiolucency will be considered radiographic failure. 13. Participant Timeline	12 months

Collaborators and Investigators

• Sponsor: Anfal mohamed elmotaz almogtaba
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; radiographic outcomes; swelling; Single visit pulpectomy; Rotary Instrumentation; Manual Instrumentation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: Rotary Files in Children

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No