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

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06151665
• Other study ID #: PED23-3D
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: sarah m. azer, master's
• Phone: 00201224553994
• Email: Sarah.azer88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

Procedure:
• single file rotary
Kedo-S plus file is the fifth generation of pediatric files will be used in pulpectomy of primary molars
• Conventional Manual K files
Stainless-steel K files is the golden standard files used in pulpectomy of primary molars

Locations

Country	Name	City	State
Egypt	Faculty of dentistry Ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Coll JA, Sadrian R. Predicting pulpectomy success and its relationship to exfoliation and succedaneous dentition. Pediatr Dent. 1996 Jan-Feb;18(1):57-63. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and Radiographical Success	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	1 year
Secondary	postoperative pain	Postoperative 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.	3 days