Assessment of Post-operative Pain After Different Instrumentation Techniques in Pulpectomy Treatment of Primary Molars

Not Applicable

Active, not recruiting

• Conditions: Pulp Necroses
• Interventions: Procedure: pulpectomy treatment will be done using the adaptive xp endo shaper.; Procedure: pulpectomy treatment will be done using FANTA AF baby files.; Procedure: pulpectomy treatment will be done using hand k files.

• Registration Number: NCT06256250
• Lead Sponsor: Mansoura University

Brief Summary

The goal of this clinical trial is to compare the post operative pain after using three different instrumentation techniques in pulpectomy treatment of pediatric participant. The main question it aims to answer:

If different instrumentation techniques will affect the post operative pain in pulpectomy treatment of primary molars ? Participants will evaluate the pain using Modified Wong baker pain rating scale.

Researchers will compare \[ the adaptive XP endo shaper, Fanta AF baby files, and hand K files\] to see if they will affect the post operative pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-10
• Study First Submitted: 2023-12-11
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-05-04
• Study Completion: 2024-05-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Cooperative children free from systemic diseases.
• Teeth with sufficient coronal tooth structure.
• Teeth with necrotic pulp.
• Teeth should have 2/3 of the remaining roots.

Exclusion Criteria

• Children taking medications up to six hours before the treatment.
• Children with multiple teeth that required pulpectomy will not be included to eliminate the possibility of pain referral.
• Excessive tooth mobility.
• Teeth with perforated pulpal floor.
• Teeth with external or internal root resorption.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (1): the adaptive xp endo shaper	pulpectomy treatment will be done using the adaptive xp endo shaper.	the root canals of primary molars will be cleaned and shaped in pulpectomy treatment using the adaptive xp endo shaper. it is single file technique saves time and help with patient cooperation.
group (2): Fanta AF baby file	pulpectomy treatment will be done using FANTA AF baby files.	the root canals of primary molars will be cleaned and shaped in pulpectomy treatment using FANTA AF baby files. it is pediatric rotary system consists of 4 files specialized for primary molars.
group (3): hand k files	pulpectomy treatment will be done using hand k files.	the root canals of primary molars will be cleaned and shaped in pulpectomy treatment using hand k files. they are manual files, they are standard for root canal treatment (control group)

Primary Outcome Measures

Name	Time	Method
Assessment of post-operative pain after pulpectomy treatment in primary teeth	one week	Assessment of post-operative pain using Modified Wong-baker pain rating scale. It is 4-point scale measures pain as: * Score zero - no pain.; * Score one - slight pain.; * Score two - moderate pain. Score three - severe pain. so ( score 0 is the best score \& score 3 is the worst) These data will be recorded at intervals of 6, 12, 24, 72 hours, and one week. A telephonic communication will be done with the parents by the second assessor who will be blinded to the treatment protocol at 6, 12, 72 hours to assess the pain, and the patients will be given two appointments, first after 24 hours and the second after one week from the operating day. During both visits, the second assessor will collect the results of the pain assessment from the child's parent and will cross-check all the results to ensure that the reported values are consistent.

Trial Locations

Locations (1)

Amal Taha Taha Elakkad; 🇪🇬 Mansoura, Egypt