Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars

NCT07319741 | Not Yet Recruiting DMC

• 1 other identifier: Rotary Files in Children
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Single visit pulpectomy; Rotary Instrumentation; Manual Instrumentation; Pain; swelling; radiographic outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of Radiographic Success of Pulpectomy

  12 months

Study Arms (2)

Group 1: Single-Visit Pulpectomy using Rotary instrumentation

ACTIVE COMPARATOR

This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using rotary instrumentation

Procedure: Rotary Instrumentation

Group2: Single-visit pulpectomy using manual instrumentation

ACTIVE COMPARATOR

This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using manual instrumentation

Procedure: Manual Instrumentation

Interventions

Rotary Instrumentation PROCEDURE

Single visit pulpectomy using rotary instrumentation

Group 1: Single-Visit Pulpectomy using Rotary instrumentation

Manual Instrumentation PROCEDURE

Single visit pulpectomy using manual instrumentation

Group2: Single-visit pulpectomy using manual instrumentation

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anfal mohamed elmotaz almogtaba: lead
• Cairo University: collaborator

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 11835, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anfal Mohammed Almogtaba, Bechlor's degree in dentistry

CONTACT

+201125202599; anfal.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The co-supervisor and main supervisor will also be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's student

Model Details: The study will include two groups with an allocation ratio of 1:1.

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

EG (1)