Single Rotary File Pulpectomy in Primary Molars

Cairo University (CU)

Status: Enrolling

Conditions: Pulpitis - Irreversible

Treatments: Device: Fanta AF baby rotary files 20 , 25 , 30 taper 4; Device: Fanta AF blue rotary files 20 taper 4

Study type: Interventional

Funder types: Other

Identifiers

NCT06146686

single rotary file pulpectomy

Details and patient eligibility

About

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

Full 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

Enrollment: 48 estimated patients

Sex: All

Ages: 4 to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Group I ( pulpectomy using single rotary file )

Experimental group

Description:

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

Treatment:

Device: Fanta AF blue rotary files 20 taper 4

Group II ( pulpectomy using multiple rotary files system )

Active Comparator group

Description:

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

Treatment:

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