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

NCT ID: NCT06151665

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Endodontically Treated Teeth

Keywords

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primary-molars pulpectomy Rotary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary molars with irreversible pulpitis
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Single Rotary file

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

Group Type EXPERIMENTAL

single file rotary

Intervention Type PROCEDURE

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

Conventional Manual Files

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.

Group Type ACTIVE_COMPARATOR

Conventional Manual K files

Intervention Type PROCEDURE

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

Interventions

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single file rotary

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

Intervention Type PROCEDURE

Conventional Manual K files

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Sarah magdy

assistant lecturer of pediatric dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of dentistry Ain shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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sarah m. azer, master's

Role: CONTACT

Phone: 00201224553994

Email: [email protected]

Facility Contacts

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sarah azer, masters

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30003514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30804311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32185634 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8668572 (View on PubMed)

Other Identifiers

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PED23-3D

Identifier Type: -

Identifier Source: org_study_id