Clinical trial NCT05744661: 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
Overall status: COMPLETED
Phase: NA
Conditions: Necrotic Pulp
Chronic Apical Periodontitis
Keywords: Mechanical Method
Chemomechanical Method
Calcium Hydroxide
Intracanal Medicament
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2023-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Effective removal of Water-based Calcium hydroxide Intracanal medicament
timeFrame: Two week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of Dentistry, Pakistan Institute of Medical Sciences
Study officials:
affiliation: Pakistan Institiute of Medical Sciences
name: Nehal Amir, BDS
role: PRINCIPAL_INVESTIGATOR
References:
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.