Postoperative Pain After Pulpectomy in Primary Molars

Evaluation of Post Operative Pain Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Device: Manual files (k files ,Mani, Inc., Japan).; Device: Fanta AF F one rotary files 20 taper 4

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hanaa A Abd El Moniem, phd; Email: hanaa.ibraheem@dentistry.cu.edu.eg
• Study Contact Backup: Name: mona a amer, master; Phone Number: +201100877939; Email: mona.amen@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Egypt
    • Cairo, Egypt, Egypt, 11411
      • Faculty of Dentistry, Cairo University
      • Contact: hanaa A Abd El Moniem, phd; Email: hanaa.ibraheem@dentistry.cu.edu.eg
      • Contact: mona a amer, master; Phone Number: +201100877939; Email: mona.amen@dentistry.cu.edu.eg
      • Principal Investigator: mona a amer, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I pulpectomy using single rotary file system; 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	Device: Fanta AF F one rotary files 20 taper 4; Fanta AF F one rotary files 20 taper 4 single rotary file system
Active Comparator: Group II pulpectomy using manual files system; 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	Device: Manual files (k files ,Mani, Inc., Japan).; manual files (k files, Mani, Inc., Japan) size 15,20,25,30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	: will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. The parent of each participant will receive 6 flashcards that include four faces and a word describing each face. 0 - None: No pain present.; - Mild: Pain is present but not distracting; easily ignored.; - Moderate: Pain is distracting; manageable but limits activities.; - Severe: Intense pain; unable to concentrate, requires immediate action or medication	At 6, 12, 24, 48 and 72 hours and 1 week after Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
child's behavior level	child's behavior level: will be recorded by using FRANKEL behavior rating Scale: rate 1 means definitely negative "refusal of treatment , fearfulness" rate 2 means negative "reluctance to accept treatment , uncooperative" rate 3 means positive "acceptance of treatment , patient follows the dentist's directions" rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment	(Immediately after treatment)
Clinical Success	Absence of swelling will be recorded by visual examination; Absence of sinus or fistula: will be recorded by visual examination.; Pathologic mobility: will be recorded by mobility test (pressure using the end of two dental mirrors)	( At 3, 6, 12 months)
Instrumentation time	will be recorded using a stopwatch	(During procedure start from anathesia till end of procedure)
The obturation quality	will be assessed using a radiograph(Using Coll and Sadrian criteria)	(Immediately after treatment)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pulpectomy; primary molars; manual instrumentation; single rotary file
• Other Study ID Numbers: MSc-pedo-pulpectomy-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data is available with the corresponding author on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No