Effect of Vachellia Nilotica Versus Sodium Hypochlorite as Root Canal Irrigant on Postoperative Pain and Bacterial Load Reduction in Mandibular Premolar Teeth With Necrotic Pulp

NCT06116214 | Unknown Phase 4

• 1 other identifier: GFSMohamed
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess the effect of V. nilotica extract solution versus 2.5% NaOCl on the intensity of postoperative pain and the amount of bacterial load reduction.

Conditions

Necrotic Pulp; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• post operative pain.

  non=0, mild=1-3, moderate4-6, sever=7-10. Measured and reported by Numerical Rating Scale (NRS). Minimum value=0, maximum value=10, the higher score or value mean a worse outcome.

  At 6, 12, 24, and 48 hours postoperatively (post instrumentation and post obturation)

Secondary Outcomes (1)

• Bacterial load reduction

  1 hour. First sample (S1) will be taken pre-intervention (before chemo-mechanical preparation) and the second sample (S2) will be taken immediately after the intervention (after completion of chemo-mechanical preparation) on the same visit.

Study Arms (2)

Control group

ACTIVE COMPARATOR

in this group the teeth will be irrigated with 2.5% Sodium Hypochlorite (gold standard)

Other: sodium hypochlorite

Experimental group

EXPERIMENTAL

in this group the teeth will be irrigated with 10% V. Nelotica (Herbal irrigant)

Other: Vachellia Nelotica

Interventions

Vachellia Nelotica OTHER

As a root canal irrigant (herbal)

Also known as: Babul

Experimental group

sodium hypochlorite OTHER

As a root canal irrigant

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patient (ASA I, II).
• Age between 20 and 40 years.
• Male or female.
• Patient who is able to sign and comprehend the pain scale (committed patient).
• Mandibular single rooted premolars having the following criteria:
• With single root canal.
• Diagnosed clinically with pulp necrosis.
• Absence of spontaneous pulpal pain.
• Positive pain on percussion denoting apical periodontitis.
• Slight widening of periodontal space or peri-apical radiolucency smaller than 3 mm (0-2mm).

You may not qualify if:

• Medically compromised patients (ASA III or IV).
• 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 will be also excluded.
• History of intolerance to NSAIDs.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Gozlan FS Mohamed

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gozlan FS Mohamed

CONTACT

+201033766933; gozlan.fouad@dentistry.cu.edu.eg

Gozlan Fouad

CONTACT

gozlan.fouad@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, master's degree student, Endodontic Department, Cairo University

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 3, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share