Mechanical Vs Chemomechanical Method For Calcium Hydroxide Removal

NCT ID: NCT05744661

Last Updated: 2023-09-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2023-06-15

Brief Summary

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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 endodontic 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.

Detailed Description

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This study is aimed at comparing the effectiveness of Mechanical and Chemomechanical methods for removal of Intracanal medication. Water-based Calcium hydroxide is used as an Intracanal medicament in this study. Participants aged 18 years and above presenting to the Outpatient department of Operative dentistry and Endodontics, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad diagnosed with Necrotic Pulp with Chronic Apical Periodontitis will be randomly allocated in two groups 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 2 weeks. 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 be removed by using Chemomechanical method. Chemomechanical method involves the use of Sonic or Ultrasonic activation of irrigants for removal of medicament. After the removal of intracanal medicament, Periodical radiograph will be taken. Data will be taken on proforma and evaluation will be done for the effective removal of calcium hydroxide using a 4- point scoring system.

Conditions

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Necrotic Pulp Chronic Apical Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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 .

Group Type EXPERIMENTAL

Mechanical Method

Intervention Type OTHER

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

Group B ( Chemomechanical Method)

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

Group Type EXPERIMENTAL

Chemomechanical Method

Intervention Type OTHER

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

Interventions

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Mechanical Method

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

Intervention Type OTHER

Chemomechanical Method

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* SINGLE-ROOTED MAXILLARY AND MANDIBULAR TEETH
* NECROTIC TEETH WITH CHRONIC APICAL PERIODONTITIS
* STRAIGHT TO MODERATELY CURVED ROOT CANALS

Exclusion Criteria

* PATIENTS WITH SYSTEMIC DISEASE
* PREGNANT AND IMMUNOCOMPROMISED PATIENTS
* TEETH WITH COMPROMISED PERIODONTAL HEALTH
* TEETH UNABLE TO BE RESTORED OR ISOLATED BY RUBBERDAM
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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NEHAL AMIR

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nehal Amir, BDS

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institiute of Medical Sciences

Locations

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School of Dentistry, Pakistan Institute of Medical Sciences

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

References

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Anis Motiwala M, Badar SB, Ghafoor R. Comparison of Two Different Methods in the Removal of Oil-Based Calcium Hydroxide From Root Canal System: A Triple-Blinded Randomised Clinical Trial. Eur Endod J. 2021 Mar;6(1):38-43. doi: 10.14744/eej.2020.78941.

Reference Type BACKGROUND
PMID: 33907070 (View on PubMed)

Amir N, Noor N. Effectiveness of mechanical vs. chemomechanical methods in removing intracanal calcium hydroxide medication: a randomised trial. J Pak Med Assoc. 2024 Oct;74(10):1749-1754. doi: 10.47391/JPMA.10990.

Reference Type DERIVED
PMID: 39407365 (View on PubMed)

Other Identifiers

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PakistanIMS

Identifier Type: -

Identifier Source: org_study_id

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