Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars

NCT ID: NCT07319741

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-02-28

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.

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.

Conditions

Pulpectomy; Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Rotary Instrumentation

Intervention Type: PROCEDURE

Single visit pulpectomy using rotary instrumentation

Group2: Single-visit pulpectomy using manual instrumentation

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

Group Type: ACTIVE_COMPARATOR

Manual Instrumentation

Intervention Type: PROCEDURE

Single visit pulpectomy using manual instrumentation

Interventions

Rotary Instrumentation

Single visit pulpectomy using rotary instrumentation

Intervention Type: PROCEDURE

Manual Instrumentation

Single visit pulpectomy using manual instrumentation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Anfal mohamed elmotaz almogtaba

OTHER

Sponsor Role: lead

Responsible Party

Anfal mohamed elmotaz almogtaba

Master's student

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Central Contacts

Anfal Mohammed Almogtaba, Bechlor's degree in dentistry

Role: CONTACT

anfal.mohamed@dentistry.cu.edu.eg

+201125202599

Other Identifiers

Rotary Files in Children

Identifier Type: -

Identifier Source: org_study_id