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NCT Number: NCT07415694

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

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?

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients:
  • Aged 4-6years, Medically free and Cooperative.
  • Teeth:
  • Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.

Pre-operative Radiographic criteria:

  • Absence of internal or external root resorption.
  • Absence of periapical or inter-radicular radiolucencies.

Exclusion criteria

  • Patients:
  • Uncooperative children.
  • Children with systemic disease.
  • Physical or mental disabilities.
  • Refusal of participation.
  • Unable to attend follow- up visits.
  • Refusal to sign the informed consent.

Teeth:

  • Previously accessed teeth.
  • Mobile mandibular primary molars.
  • Pain on percussion.
  • Swelling in the vestibule or on palpation.

Treatment and study plan

Fanta AF F one rotary files 20 taper 4

Device

single rotary file system Fanta AF F one rotary files 20 taper 4

Manual files (k files ,Mani, Inc., Japan).

Device

manual files (k files, Mani, Inc., Japan) size 15,20,25,30

Primary outcomes

  1. • child's behavior level

    Time frame: Immediately after treatment

    child's behavior level using Frankl's behavior rating scale

    • rate 1 means definitely negative "refusal of treatment , fearfulness"
    • rate 2 means negative "reluctance to accept treatment , uncooperative"
    • rate 3 means positive "acceptance of treatment , patient follows the dentist's directions"
    • rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment"

Secondary outcomes

  1. Post-operative pain

    Time frame: at 6, 12, 24, 48 and 72 hours and 1 week after treatment.

    Asking the patient and/or Guardian using a 4-point pain scale, the parent of each participant will receive 6 flashcards that include four faces and a word describing each face.

    0 - None: No pain present.

    • - Mild: Pain is present but not distracting; easily ignored.
    • - Moderate: Pain is distracting; manageable but limits activities.
    • - Severe: Intense pain; unable to concentrate, requires immediate action or medication.
  2. Obturation quality

    Time frame: Immediately after treatment.

    Periapical radiograph (Using Coll and Sadrian criteria)

  3. Instrumentation time

    Time frame: During treatment

    using stopwatch

Study contacts

Contact information is provided by the study sponsor or research team.

Hanaa A Abd El Moniem, Phd

CONTACT

[email protected]

amira M ibrahim, master

CONTACT

[email protected]

+201002585750

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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