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

Not Applicable

Not yet recruiting

• Conditions: Intervention
• Interventions: Other: Calcium Hypochlorite as Root Canal Irrigant

• Registration Number: NCT06509295
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-06-24
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-13
• Last Update Submitted: 2024-07-13
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Study Start: 2024-08-29
• Primary Completion: 2025-04-20
• Study Completion: 2025-05-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Hypochlorite as a root Canal Irrigant	Calcium Hypochlorite as Root Canal Irrigant	Treatment with Sodium Hypochlorite as root canal Irrigant
Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction	Calcium Hypochlorite as Root Canal Irrigant	Treatment with Calcium Hypochlorite as root canal Irrigant

Primary Outcome Measures

Name	Time	Method
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain in Mandibular Premolars with Necrotic Pulps.	measured at 6, 12, 24, 48 hours after single visit treatment	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.

Secondary Outcome Measures

Name	Time	Method
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.	T0=Baseline immediate after access preparation . T1=Post-instrumentation. T1(within an hour)	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.
Number of analgesic tablets taken by the patient after endodontic treatment	Up to 48 hours postoperative.	Number of analgesic tablets taken by the patient after endodontic treatment Up to 48 hours postoperative.; Measuring tool: counting Measurment unite: numerical.