A Comparative Study Between Single Rotary File System and Conventional Manual K-File in Pulpectomy of Primary Molars.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Clinical and Radiographical Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Absence of external or internal root resorption
- •presence of two thirds of the root
- •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.
Outcomes
Primary Outcomes
Clinical and Radiographical Success
Time Frame: 1 year
Clinical 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 Outcomes
- postoperative pain(3 days)
Investigators
Sarah magdy
assistant lecturer of pediatric dentistry
Ain Shams University