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

NCT06509295 | Not Yet Recruiting

• 1 other identifier: ENDO 3-7-1(10/4/2024)
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• Number of analgesic tablets taken by the patient after endodontic treatment

  Up to 48 hours postoperative.

Study Arms (2)

Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction

PLACEBO COMPARATOR

Treatment with Calcium Hypochlorite as root canal Irrigant

Other: Calcium Hypochlorite as Root Canal Irrigant

Sodium Hypochlorite as a root Canal Irrigant

ACTIVE COMPARATOR

Treatment with Sodium Hypochlorite as root canal Irrigant

Other: Calcium Hypochlorite as Root Canal Irrigant

Interventions

Calcium Hypochlorite as Root Canal Irrigant OTHER

Calcium Hypochlorite used as root canal irrigant during chemo-mechanical preparation

Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction; Sodium Hypochlorite as a root Canal Irrigant

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Medically compromised patients having significant systemic disorders. (ASA III or IV).
• History of intolerance to NSAIDS.
• 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.
• Patients who could not interpret the NRS.
• Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

calcium hypochlorite; Root Canal Irrigants

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Dental Disinfectants; Disinfectants; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Youmna Yassen Youmna Yassen, pds

CONTACT

01146877037; youmna_yassen@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, resident at faculty of dentistry

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 19, 2024
• Study Start: August 29, 2024
• Primary Completion: April 20, 2025
• Study Completion: May 29, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07