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Single Rotary File System Versus Conventional Manual K-file in Pulpectomy of Primary Molars.

A Comparative Study Between Single Rotary File System and Conventional Manual K-File in Pulpectomy of Primary Molars.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06151665
Enrollment
30
Registered
2023-11-30
Start date
2023-12-01
Completion date
2024-12-01
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontically Treated Teeth

Keywords

primary-molars, pulpectomy, Rotary

Brief summary

The sample size will be divided between two groups, Group A pulpectomy will be done using single rotary file in primary molars and group B pulpectomy will be done using manual K file system. follow up of the patients and clinical and radiographical success rates of cases will be seen.

Detailed description

Each patient will have access in the primary molar and pulpectomy procedure will be done according to inclusion and exclusion criteria , the patients will be divided according to two groups Group A using single File rotary and group B manual K file system. Time will be recorded in each procedure and each patient will receive stainless steel crown. Follow up for the patients will be done clinical and radiographical success will be seen, postoperative pain will be measured and all data will be collected and statistically analyzed.

Interventions

PROCEDUREsingle file rotary

Kedo-S plus file is the fifth generation of pediatric files will be used in pulpectomy of primary molars

PROCEDUREConventional Manual K files

Stainless-steel K files is the golden standard files used in pulpectomy of primary molars

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

an external pediatric Dentist will assess the radiographic and clinical follow-up of the enrolled patients

Intervention model description

Primary molars with irreversible pulpitis

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes

Inclusion criteria

1. Absence of external or internal root resorption 2. presence of two thirds of the root 3. Primary molars with deep caries and irreversible pulpitis that require pulpectomy in a single visit. Molars can be vital with a history of spontaneous pain or non-vital as indicated by absence of bleeding from the pulp.

Exclusion criteria

* Children with physical, intellectual disability or medical conditions that may complicate treatment. * Teeth with poor prognosis due to the presence of a sinus, excessive mobility or advanced bone resorption. * Teeth with radiolucent areas in furcation regions.

Design outcomes

Primary

MeasureTime frameDescription
Clinical and Radiographical Success1 yearClinical evaluation to swelling, fistula and pain on percussion by clinical examination followed by a radiographic evaluation to absence of periapical and inter-radicular radiolucency, external or internal root resorption according to radiographic images

Secondary

MeasureTime frameDescription
postoperative pain3 daysPostoperative pain will be recorded at six, 12, 24, 48, and72 hours following the pulpectomy. To ensure standardization, the same parent will be asked to record the pain intensity at all intervals as told by the child. Wong Bakers FACES Pain Rating Scale (WB-FPRS) will be employed to assess post-operative pain. The scale is a pictorial representation of the discomfort level experienced by children which comprise six faces, each depicting an expression of pain. Also visual Analogue Scale (VAS) for pain assessment will be used.

Countries

Egypt

Contacts

Primary Contactsarah m. azer, master's
Sarah.azer88@gmail.com00201224553994

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026