Clinical trial NCT06151665: Single Rotary File System Versus Conventional Manual K-file in Pulpectomy of Primary Molars.
Official title: A Comparative Study Between Single Rotary File System and Conventional Manual K-File in Pulpectomy of Primary Molars.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: primary-molars
pulpectomy
Rotary
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary molars with irreversible pulpitis
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical and Radiographical Success
timeFrame: 1 year
Secondary outcomes:
measure: postoperative pain
timeFrame: 3 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Ain shams University
Study officials:
References:
citation: Jeevanandan G, Govindaraju L. Clinical comparison of Kedo-S paediatric rotary files vs manual instrumentation for root canal preparation in primary molars: a double blinded randomised clinical trial. Eur Arch Paediatr Dent. 2018 Aug;19(4):273-278. doi: 10.1007/s40368-018-0356-6. Epub 2018 Jul 12.
citation: Panchal V, Jeevanandan G, Subramanian E. Comparison of instrumentation time and obturation quality between hand K-file, H-files, and rotary Kedo-S in root canal treatment of primary teeth: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2019 Jan-Mar;37(1):75-79. doi: 10.4103/JISPPD.JISPPD_72_18.
citation: Priyadarshini P, Jeevanandan G, Govindaraju L, Subramanian EMG. Clinical evaluation of instrumentation time and quality of obturation using paediatric hand and rotary file systems with conventional hand K-files for pulpectomy in primary mandibular molars: a double-blinded randomized controlled trial. Eur Arch Paediatr Dent. 2020 Dec;21(6):693-701. doi: 10.1007/s40368-020-00518-w. Epub 2020 Mar 17.
citation: Coll JA, Sadrian R. Predicting pulpectomy success and its relationship to exfoliation and succedaneous dentition. Pediatr Dent. 1996 Jan-Feb;18(1):57-63.