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Clinical Trials/NCT05744661
NCT05744661
Completed
Not Applicable

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

Pakistan Institute of Medical Sciences1 site in 1 country60 target enrollmentStarted: December 16, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Effective removal of Water-based Calcium hydroxide Intracanal medicament

Overview

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 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

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Effective removal of Water-based Calcium hydroxide Intracanal medicament

Time Frame: Two 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

NEHAL AMIR

Principal Investigator

Pakistan Institute of Medical Sciences

Study Sites (1)

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