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

NCT ID: NCT06256250

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2024-05-11

Brief Summary

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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

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Conditions

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Pulp Necroses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

pulpectomy treatment will be done using the adaptive xp endo shaper.

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

pulpectomy treatment will be done using FANTA AF baby files.

Intervention Type PROCEDURE

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.

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)

Group Type ACTIVE_COMPARATOR

pulpectomy treatment will be done using hand k files.

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Amal Taha

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amal Taha Taha Elakkad

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A0106023PP

Identifier Type: -

Identifier Source: org_study_id

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