NCT07319741

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Anfal mohamed elmotaz almogtaba · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Rotary Instrumentation	Single visit pulpectomy using rotary instrumentation
PROCEDURE	Manual Instrumentation	Single visit pulpectomy using manual instrumentation

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: Egypt