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NCT05744661 Clinical Trial

Mechanical Vs Chemomechanical Method For Calcium Hydroxide Removal

Necrotic Pulp Clinical Trial

Official title:
Effectiveness of Mechanical vs. Chemomechanical Methods in Removing Intracanal Calcium Hydroxide Medication: a Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05744661
Other study ID # PakistanIMS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 16, 2022
Est. completion date June 15, 2023

Study information
Verified date September 2023
Source Pakistan Institute of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Mechanical Method
Use of Rotary Master Apical file for the removal of Calcium Hydroxide Medicament from Root Canal System
• Chemomechanical Method
Sonic Activation of Endodontic irrigants for the removal of Calcium Hydroxide from Root Canal System

Locations
Country Name City State
Pakistan School of Dentistry, Pakistan Institute of Medical Sciences Islamabad

Sponsors (1)
Lead Sponsor Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Effective removal of Water-based Calcium hydroxide Intracanal medicament 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. Two week
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