Postoperative Pain After Pulpectomy in 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 Post Operative Pain Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
Overview
To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial. The main question it aims to answer is: Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?
Detailed description
Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems
* Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer * In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain * Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth * Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain * Postoperative pain is one way to measure the success of endodontic treatment
Interventions
- Device Fanta AF F one rotary files 20 taper 4
Fanta AF F one rotary files 20 taper 4 single rotary file system - Device Manual files (k files ,Mani, Inc., Japan).
manual files (k files, Mani, Inc., Japan) size 15,20,25,30
Primary outcome measures
- Post-operative pain [Time frame: At 6, 12, 24, 48 and 72 hours and 1 week after Treatment]
Secondary outcome measures (4)
- child's behavior level [Time frame: (Immediately after treatment)]
- Clinical Success [Time frame: ( At 3, 6, 12 months)]
- Instrumentation time [Time frame: (During procedure start from anathesia till end of procedure)]
- The obturation quality [Time frame: (Immediately after 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: NCT07427420 · MSc-pedo-pulpectomy-01