Postoperative Pain After Pulpectomy in Primary Molars

NCT07427420 | Not Yet Recruiting

• 1 other identifier: MSc-pedo-pulpectomy-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Irreversible Pulpitis

Keywords

single rotary file; pulpectomy; primary molars; manual instrumentation

Outcome Measures

Primary Outcomes (1)

• 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. 1. \- Mild: Pain is present but not distracting; easily ignored. 2. \- Moderate: Pain is distracting; manageable but limits activities. 3. \- 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 Outcomes (4)

• child's behavior level

  (Immediately after treatment)

• Clinical Success

  ( At 3, 6, 12 months)

• Instrumentation time

  (During procedure start from anathesia till end of procedure)

• The obturation quality

  (Immediately after treatment)

Study Arms (2)

Group I pulpectomy using single rotary file system

EXPERIMENTAL

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

Group II pulpectomy using manual files system

ACTIVE COMPARATOR

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).

Interventions

Fanta AF F one rotary files 20 taper 4 DEVICE

Fanta AF F one rotary files 20 taper 4 single rotary file system

Group I pulpectomy using single rotary file system

Manual files (k files ,Mani, Inc., Japan). DEVICE

manual files (k files, Mani, Inc., Japan) size 15,20,25,30

Group II pulpectomy using manual files system

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt, 11411, Egypt

Location

Central Study Contacts

Mona A amer, Master

CONTACT

+201100877939; mona.amen@dentistry.cu.edu.eg

Hanaa A Abd El Moniem, Phd

CONTACT

hanaa.ibraheem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The blinding of operator is not possible due to the nature of the technique used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Candidate in Department of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 23, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)