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Mechanical Vs Chemomechanical Method For Calcium Hydroxide Removal

Primary Purpose

Necrotic Pulp, Chronic Apical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mechanical Method
Chemomechanical Method
Sponsored by
Pakistan Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Necrotic Pulp focused on measuring Mechanical Method, Chemomechanical Method, Calcium Hydroxide, Intracanal Medicament

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dentistry, Pakistan Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (Mechanical Method)

Group B ( Chemomechanical Method)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2023
Last Updated
September 18, 2023
Sponsor
Pakistan Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05744661
Brief Title
Mechanical Vs Chemomechanical Method For Calcium Hydroxide Removal
Official Title
Effectiveness of Mechanical vs. Chemomechanical Methods in Removing Intracanal Calcium Hydroxide Medication: a Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Institute of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp, Chronic Apical Periodontitis
Keywords
Mechanical Method, Chemomechanical Method, Calcium Hydroxide, Intracanal Medicament

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Mechanical Method)
Arm Type
Experimental
Arm Description
In Group A, Calcium Hydroxide Intracanal Medicament will be removed by using Mechanical Method in which Rotary Master Apical File will be used .
Arm Title
Group B ( Chemomechanical Method)
Arm Type
Experimental
Arm Description
In Group B, Calcium Hydroxide Intracanal Medicament will be removed by using Chemomechanical Method which involves Sonic Agitation of Endodontic irrigants.
Intervention Type
Other
Intervention Name(s)
Mechanical Method
Intervention Description
Use of Rotary Master Apical file for the removal of Calcium Hydroxide Medicament from Root Canal System
Intervention Type
Other
Intervention Name(s)
Chemomechanical Method
Intervention Description
Sonic Activation of Endodontic irrigants for the removal of Calcium Hydroxide from Root Canal System
Primary Outcome Measure Information:
Title
Effective removal of Water-based Calcium hydroxide Intracanal medicament
Description
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.
Time Frame
Two week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehal Amir, BDS
Organizational Affiliation
Pakistan Institiute of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, Pakistan Institute of Medical Sciences
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33907070
Citation
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.
Results Reference
background

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Mechanical Vs Chemomechanical Method For Calcium Hydroxide Removal

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