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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorCairo University

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.

Absence of internal or external root resorption.

Absence of periapical or inter-radicular radiolucencies.

Disqualifiers

Uncooperative children.

Children with systemic disease.

Physical or mental disabilities.

Refusal of participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Group I pulpectomy using single rotary file systemExperimental treatment 1 intervention
Group B: Group II pulpectomy using manual files systemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

• child's behavior level

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"

Time frame
Immediately after treatment

Secondary outcomes

1

Post-operative pain

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. 1. \- Mild: Pain is present but not distracting; easily ignored. 2. \- Moderate: Pain is distracting; manageable but limits activities. 3. \- Severe: Intense pain; unable to concentrate, requires immediate action or medication.

Time frame
at 6, 12, 24, 48 and 72 hours and 1 week after treatment.
2

Obturation quality

Periapical radiograph (Using Coll and Sadrian criteria)

Time frame
Immediately after treatment.
3

Instrumentation time

using stopwatch

Time frame
During treatment

Other outcomes

Sponsors and contacts

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