NCT07415694

Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars

Evaluation of Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars - A Randomized Clinical Trial (RCT)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The primary aim is to compare the behavior of the children during using conventional manual instrumentation versus rotary instrumentation by single rotary system for pulpectomy in primary molars through a Randomized Clinical Trial. The main question it aims to answer is: Is there a difference in the behavior of the children when using single rotary file system versus manual instrumentation in pulpectomy in primary molars?

Detailed description

Pulpectomy has gained popularity in the pediatric dental practice for preserving the primary teeth in its position until exfoliation. There has been a paradigm shift from using manual instrumentation to rotary instrumentation for canal preparation in primary teeth. While studies show that there is a reduction in the instrumentation time with the use of rotary instruments which in turn influences the behavior of the child, its direct effect on the behavior of the children has not been evaluated . The behavior of children plays an integral component and is the primary requisite of the pediatric dental practice. Assessment of child's behavior during a dental procedure is one of the most important skills of a pediatric dentist for successful completion of the dental treatment . Interestingly, it has been noted that the treatment duration of patients with anxiety or behavior management problem is on average 40% more than that of normal patients going through the same procedure . Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure. These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications. With these options, dentists can perform the pulpectomy with less psychological trauma to the child thus decreasing the anxiety and instilling positive behavior. The acceptance rate of the proposed method of treatment by the child may also increase. Furthermore, the use of a rotary file system may maintain a balance between the treatment duration and efficient behavior management in children.

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
DEVICE	Fanta AF F one rotary files 20 taper 4	single rotary file system Fanta AF F one rotary files 20 taper 4
DEVICE	Manual files (k files ,Mani, Inc., Japan).	manual files (k files, Mani, Inc., Japan) size 15,20,25,30

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2026-02-17
• Last updated: 2026-02-18

Locations

1 site across 1 country: Egypt