NCT06151665

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 16, 2023

Last Update Submit

November 21, 2023

Conditions

Endodontically Treated Teeth

Keywords

primary-molarspulpectomyRotary

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • postoperative pain

    3 days

Study Arms (2)

Single Rotary file

EXPERIMENTAL

single rotary file will be used in primary molars to preform pulpectomy then restored with zinc oxide eugenol and stainless steel crown.

Procedure: single file rotary

Conventional Manual Files

ACTIVE COMPARATOR

Conventional Manual Stainless steel K files will be used in primary molars to preform pulpectomy then restored with zinc oxide eugenol and stainless steel crown.

Procedure: Conventional Manual K files

Interventions

single file rotaryPROCEDURE

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

Single Rotary file
Conventional Manual K filesPROCEDURE

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

Conventional Manual Files

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Ain shams University

Cairo, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 30003514BACKGROUND

  • 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.

    PMID: 30804311BACKGROUND

  • 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.

    PMID: 32185634BACKGROUND

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

    PMID: 8668572BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Central Study Contacts

sarah m. azer, master's

CONTACT

00201224553994Sarah.azer88@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
an external pediatric Dentist will assess the radiographic and clinical follow-up of the enrolled patients
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Primary molars with irreversible pulpitis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of pediatric dentistry

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 30, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

EG(1)