NCT05744661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

February 16, 2023

Last Update Submit

September 18, 2023

Conditions

Necrotic PulpChronic Apical Periodontitis

Keywords

Mechanical MethodChemomechanical MethodCalcium HydroxideIntracanal Medicament

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group A (Mechanical Method)

EXPERIMENTAL

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

Group B ( Chemomechanical Method)

EXPERIMENTAL

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

Other: Chemomechanical Method

Interventions

Mechanical MethodOTHER

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

Group A (Mechanical Method)
Chemomechanical MethodOTHER

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

Group B ( Chemomechanical Method)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • PATIENTS WITH SYSTEMIC DISEASE
  • PREGNANT AND IMMUNOCOMPROMISED PATIENTS
  • TEETH WITH COMPROMISED PERIODONTAL HEALTH
  • TEETH UNABLE TO BE RESTORED OR ISOLATED BY RUBBERDAM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Pakistan Institute of Medical Sciences

Islamabad, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 33907070BACKGROUND

  • 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.

    PMID: 39407365DERIVED

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nehal Amir, BDS

    Pakistan Institiute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

December 16, 2022

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)