Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fanta AF F one rotary files 20 taper 4, Manual files (k files ,Mani, Inc., Japan)..
- Who it may be relevant to
- Registry conditions: Irreversible Pulpitis. Basic parameters: 4 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars - A Randomized Clinical Trial (RCT)
Overview
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.
Interventions
- 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
Primary outcome measures
- • child's behavior level [Time frame: Immediately after treatment]
Secondary outcome measures (3)
- Post-operative pain [Time frame: at 6, 12, 24, 48 and 72 hours and 1 week after treatment.]
- Obturation quality [Time frame: Immediately after treatment.]
- Instrumentation time [Time frame: During treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Cairo University — Cairo
Identifiers
NCT: NCT07415694 · Pedo departmenCairo University