Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. .

Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. A Randomized Clinical Trial.

This study aims to assess the effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.

Study Overview

• Status: Not yet recruiting
• Conditions: Intervention
• Intervention / Treatment: Other: Calcium Hypochlorite as Root Canal Irrigant

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youmna Yassen Youmna Yassen, pds; Phone Number: 01146877037; Email: youmna_yassen@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Systematically healthy patient (ASA I, II).
2. Age between 20 and 55 years
3. Male or female.
4. Mandibular premolar teeth having single canals diagnosed with pulp necrosis with asymptomatic apical periodontitis.
5. Radiographic examination using Digora intraoral periapical sensor plate and software showing mandibular premolars with (0-2 mm) periapical radiolucency.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.

3. Teeth with:

   • Immature roots
   • Vital pulp tissues.
   • Association with swelling.
   • Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   • Mobility Grade II or III.
   • Previously accessed or endodontically treated
   • Deep periodontal pockets more than 4 mm
   • Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
4. Patients who could not interpret the NRS.
5. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction; Treatment with Calcium Hypochlorite as root canal Irrigant	Other: Calcium Hypochlorite as Root Canal Irrigant; Calcium Hypochlorite used as root canal irrigant during chemo-mechanical preparation
Active Comparator: Sodium Hypochlorite as a root Canal Irrigant; Treatment with Sodium Hypochlorite as root canal Irrigant	Other: Calcium Hypochlorite as Root Canal Irrigant; Calcium Hypochlorite used as root canal irrigant during chemo-mechanical preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain in Mandibular Premolars with Necrotic Pulps.	measuring tool: Numerical Rating Scale (NRS). Unite of measurement: Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10 Time of measurements: At 6, 12, 24, 48- hours post-treatment.	measured at 6, 12, 24, 48 hours after single visit treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.	Intracanal bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFUs/ml), The growth will be semi quantitatively determined as very heavy, heavy, moderate, sparse and very sparse depending on the CFU ranging from >100,000,˂100,000,˂10,000,˂1,000, ˂100 colony forming unit per 1 ml BHI respectively.	T0=Baseline immediate after access preparation . T1=Post-instrumentation. T1(within an hour)
Number of analgesic tablets taken by the patient after endodontic treatment	Number of analgesic tablets taken by the patient after endodontic treatment Up to 48 hours postoperative. Measuring tool: counting Measurment unite: numerical.	Up to 48 hours postoperative.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 29, 2024
• Primary Completion (Estimated): April 20, 2025
• Study Completion (Estimated): May 29, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 13, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Dental Pulp Necrosis; Physiological Effects of Drugs; Anti-Infective Agents; Calcium-Regulating Hormones and Agents; Disinfectants; Dental Disinfectants; Calcium; Root Canal Irrigants
• Other Study ID Numbers: ENDO 3-7-1(10/4/2024)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No