Mechanical Vs Chemomechanical Method For Calcium Hydroxide Removal

Sponsor

Pakistan Institute of Medical Sciences (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05744661

Collaborator

(none)

Enrollment

Location

Arms

5.1

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Type of study: Randomised Clinical trial To compare the effectiveness of Mechanical and Chemomechanical methods in the removal of Water-based Calcium hydroxide medicament from Root canal system.

Participants allocated in group A and B should be appointed for Endodontic treatment of Single rooted teeth diagnosed with Necrotic Pulp and Chronic Apical Periodontitis.

In group A, Calcium hydroxide medicament will be removed by using Mechanical method while in group B, Calcium hydroxide will be removed by using Chemomechanical method.

Condition or Disease	Intervention/Treatment	Phase
Necrotic Pulp Chronic Apical Periodontitis	Other: Mechanical Method Other: Chemomechanical Method	N/A

Detailed Description

This study is aimed at comparing the effectiveness of Mechanical and Chemomechanical methods for removal of Intracanal medicament. Water-based Calcium hydroxide is used as Intracanal medicament in this study.Participants aged 18 years and above presenting to the Outpatient department of Operative dentistry and Endodontics, School of Dentistry diagnosed with Necrotic Pulp with Chronic Apical Periodontitis will be randomly allocated in two groups. Random allocation will be done by Computerized method in group A and B. On first visit, Root canal treatment will be initiated under rubber dam isolation. After locating canals, periapical radiograph for the working length will be taken. After working length has been confirmed, canal preparation will be done using Rotary file system.After canal has been prepared till working length, intracanal medicament is placed using Lentulospiral. Patient is recalled after 1 week. On next visit, Calcium hydroxide medicament will be removed by Mechanical method from group A. Mechanical method involves the use of Rotary file system for removal of medicament. In group B, Calcium hydroxide will br removed by using Chemomechanical method. Chemomechanical method involves the use of Sonic or Ultrasonic activation of irrigant for removal of medicament.After the removal of intracanal medicament, Periodical radiograph will be taken.Data will be taken pro forma and evaluation will be done for the effective removal of calcium hydroxide using a 4 graded scoring system.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a Parallel type, Non-random Consecutive Sampling Technique. Patients reporting to the Department of Operative Dentistry & Endodontics, School of Dentistry with Necrotic teeth will be filtered. All participants who fulfil the Inclusion and Exclusion criteria will be enrolled in this study.This is a Parallel type, Non-random Consecutive Sampling Technique. Patients reporting to the Department of Operative Dentistry & Endodontics, School of Dentistry with Necrotic teeth will be filtered. All participants who fulfil the Inclusion and Exclusion criteria will be enrolled in this study.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

This is a triple-blinded study. Participants will be unaware of the intervention they will recieve. All interventions will be performed by Single Care Provider (Clinician). Due to the nature of intervention, care provider cannot be masked. Data collector (Investigator) and Data Analyst(Outcome Assessor) both will be blinded.

Primary Purpose:

Other

Official Title:

Comparative Evaluation Of Mechanical And Chemomechanical Methods For The Effective Removal Of Water-Based Calcium Hydroxide Medicament From Root Canal System

Actual Study Start Date :

Sep 28, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (Mechanical Method) In Group A, Calcium Hydroxide Intracanal Medicament will be removed by using Mechanical Method in which Rotary Master Apical File will be used .	Other: Mechanical Method Use of Rotary Master Apical file for the removal of Calcium Hydroxide Medicament from Root Canal System
Experimental: Group B ( Chemomechanical Method) In Group B, Calcium Hydroxide Intracanal Medicament will be removed by using Chemomechanical Method which involves Sonic Agitation of Endodontic file.	Other: Chemomechanical Method Sonic Activation of Endodontic file for the removal of Calcium Hydroxide from Root Canal System

Arm

Intervention/Treatment

Experimental: Group A (Mechanical Method)

In Group A, Calcium Hydroxide Intracanal Medicament will be removed by using Mechanical Method in which Rotary Master Apical File will be used .

Other: Mechanical Method

Use of Rotary Master Apical file for the removal of Calcium Hydroxide Medicament from Root Canal System

Experimental: Group B ( Chemomechanical Method)

In Group B, Calcium Hydroxide Intracanal Medicament will be removed by using Chemomechanical Method which involves Sonic Agitation of Endodontic file.

Other: Chemomechanical Method

Sonic Activation of Endodontic file for the removal of Calcium Hydroxide from Root Canal System

Outcome Measures

Primary Outcome Measures

Effective removal of Water-based Calcium hydroxide Intracanal medicament [1 week]
The effectiveness of mechanical and chemomechanical methods for the removal of calcium hydroxide will be evaluated using a 4 graded scoring system used in endodontics.