Single Rotary File Pulpectomy in Primary Molars

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars

NCT07319741

Pulpectomy Irreversible Pulpitis

NOT_YET_RECRUITING NA

Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

NCT05059171

Postoperative Pain

COMPLETED NA

Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals

NCT03684915

Chronic Infection

UNKNOWN NA

Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation

NCT03964766

Chronic Infection

UNKNOWN NA

Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation

NCT05619796

Manual; Rotation Obturation Post Operative Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulpitis - Irreversible

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I ( pulpectomy using single rotary file )

After opening the access cavity, a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline

Group Type EXPERIMENTAL

Fanta AF blue rotary files 20 taper 4

Intervention Type DEVICE

single rotary file Fanta AF blue rotary files 20 taper 4

Group II ( pulpectomy using multiple rotary files system )

After opening the access cavity, multiple rotary files system (Fanta AF baby rotary files 20 taper 4, 25 taper 4, 30 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at rotational speed 300 rpm with torque set at the lowest level, irrigation with saline

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fanta AF blue rotary files 20 taper 4

single rotary file Fanta AF blue rotary files 20 taper 4

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .