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

Pulp Necroses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06256250
• Other study ID #: A0106023PP
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: May 11, 2024

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: May 11, 2024
• Est. primary completion date: May 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pain, Postoperative
• Pulp Necroses

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Amal Taha Taha Elakkad	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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