Postoperative Pain After Pulpectomy in Primary Molars

Cairo University (CU)

Status: Not yet enrolling

Conditions: Irreversible Pulpitis

Treatments: Device: Manual files (k files ,Mani, Inc., Japan).; Device: Fanta AF F one rotary files 20 taper 4

Study type: Interventional

Funder types: Other

Identifiers

NCT07427420

MSc-pedo-pulpectomy-01

Details and patient eligibility

About

To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial.

The main question it aims to answer is:

Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?

Full description

Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems

• Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer
• In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain
• Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth
• Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain
• Postoperative pain is one way to measure the success of endodontic treatment

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Patients:

  • Aged 4-6years, Medically free and Cooperative.
  • Teeth:
  • Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.

Pre-operative Radiographic criteria:

• Absence of internal or external root resorption.
• Absence of periapical or inter-radicular radiolucencies.

Exclusion criteria

• • Patients:

  • Uncooperative children.
  • Children with systemic disease.
  • Physical or mental disabilities.
  • Refusal of participation.
  • Unable to attend follow- up visits.
  • Refusal to sign the informed consent.

Teeth:

• Previously accessed teeth.
• Mobile mandibular primary molars.
• Pain on percussion.
• Swelling in the vestibule or on palpation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group I pulpectomy using single rotary file system

Experimental group

Description:

Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size #10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (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 F one rotary files 20 taper 4

Group II pulpectomy using manual files system

Active Comparator group

Description:

Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline

Treatment:

Device: Manual files (k files ,Mani, Inc., Japan).