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

The Effect of Different Instrumentation Techniques on the Post-Operative Pain in Pulpectomy Treatment of Primary Molars: A Blind Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulp Necroses
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Amal Taha Taha Elakkad

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group (1): 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.	Procedure: pulpectomy treatment will be done using the adaptive xp endo shaper.; the patient will be anesthetized by local anesthesia. the rubber dam will be used for isolation. caries will be removed using high speed handpiece. determination of working length using apex locator. the canal patency will be checked with a # 10 K file, and gliding path until #15 K- file. 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 . the endomotor will be activated at aspeed of 800 rpm and 1 Ncm torque. the canals will be irrigated using 2.5% Nacol ending with 0.9% normal saline canal irrigation. the canals will be dried with paper points and obturated with Metapex. teeth will be restored by glass ionomer restoration than stainless steel crown.
Experimental: group (2): Fanta AF baby file; 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.	Procedure: pulpectomy treatment will be done using FANTA AF baby files.; the patient will be anesthetized by local anesthesia. the rubber dam will be used for isolation. caries will be removed using high speed handpiece. determination of working length using apex locator. The canal patency will be checked with a #10 K-file, and a glide path until #15 K-file will be created .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.Open file: #17, taper 08.; BTF1: #20, taper 04, Yellow; BTF2: #25, taper 04, Red; BTF3: #30, taper 04, Blue The file will be activated at speed 350 rpm and torque 2 N until reaching the full working length. the canals will be irrigated using 2.5% Nacol ending with 0.9% normal saline canal irrigation. the canals will be dried with paper points and obturated with Metapex. teeth will be restored by glass ionomer restoration than stainless steel crown.
Active Comparator: group (3): 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)	Procedure: pulpectomy treatment will be done using hand k files.; the patient will be anesthetized by local anesthesia. the rubber dam will be used for isolation. caries will be removed using high speed handpiece. determination of working length using apex locator. the root canals of primary molars will be cleaned and shaped in pulpectomy treatment using hand k files starting with #15 stainless steel hand K file. they are manual files, they are standard for root canal treatment (control group). the canals will be irrigated using 2.5% Nacol ending with 0.9% normal saline canal irrigation. the canals will be dried with paper points and obturated with Metapex. teeth will be restored by glass ionomer restoration than stainless steel crown.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of post-operative pain after pulpectomy treatment in primary teeth	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.	one week

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): May 4, 2024
• Study Completion (Estimated): May 11, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pulpectomy, XP endo shaper, post operative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Necrosis; Dental Pulp Necrosis
• Other Study ID Numbers: A0106023PP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes