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Single Rotary File Pulpectomy in Primary Molars

Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06146686
Enrollment
48
Registered
2023-11-27
Start date
2024-02-01
Completion date
2025-04-30
Last updated
2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

Keywords

single rotary file pulpectomy , primary molars

Brief summary

The aim of this study is to compare the clinical effectiveness of a single rotary file system versus a multiple rotary files system in pulpectomy of primary molars

Detailed description

In pediatric dentistry, premature loss of necrotic primary molars has been a matter of great concern over the years. In modern pedodontic practice, Pulpectomy is regarded as the choice modality of treatment for pulpally involved necrotic teeth. Hand files are used for mechanical preparation of primary tooth during pulpectomy but it has been found to be time consuming and may negatively influence the child's behavior . Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure. These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications. Up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of single rotary file systems versus multiple rotary files systems when used in pulpectomy of primary molars. Thus, the present study aims to investigate the clinical effectiveness of those two techniques

Interventions

DEVICEFanta AF blue rotary files 20 taper 4

single rotary file Fanta AF blue rotary files 20 taper 4

DEVICEFanta AF baby rotary files 20 , 25 , 30 taper 4

multiple rotary files system Fanta AF baby rotary files 20 , 25 , 30 taper 4

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded

Eligibility

Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

* Children Criteria: * Medically free . * Cooperative patient. Molar criteria : • Mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis Radiographic criteria: * No evidence of internal/external pathologic root resorption. * With or without periapical or furcal lesion .

Exclusion criteria

* • Uncooperative children. * Children with systemic disease. * Lack of informed consent by the child patient's parent. * Refusal of participation.

Design outcomes

Primary

MeasureTime frameDescription
instrumentation timeduring the operationinstrumentation time of pulpectomy using single rotary file by stopwatch

Secondary

MeasureTime frameDescription
child's cooperation levelbaseline and during the operationchild's cooperation level using Frenkel's behaviour rating scale using Grades ( 1- Definitely negative 2- negative 3- positive 4- definitely positive )
obturation qualityimmediately after the operationobturation quality measuring using periapical radiographs using Coll and Sadrian criteria ( scores) the quality of the root canal filling was defined as : 1. underfilling : all the canals were filled more than 2 mm short of the apex 2. optimal filling : one or more of the canals having the obturant ending at the radiographic apex or up to 2 mm short of the apex 3. overfilling : any canal showing obturant outside the root

Countries

Egypt

Contacts

Primary ContactMennat-Allah Eid Ahmed, MAster
mennaallah-eid@dentistry.cu.edu.eg0201119309905
Backup ContactReem mohamed fouad, PHD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026