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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Operative Pain; Necrotic Pulp
• Intervention / Treatment: Other: sodium hypochlorite; Other: Vachellia Nelotica

Detailed Description

Clinical compare the effect of V. nilotica extract solution versus 2.5% NaOCl on the intensity of postoperative pain and the amount of bacterial load reduction when used as root canal irrigant in necrotic pulp. The post operative pain will be recorded using Numerical rating scale, and the bacterial load reduction will be measured by Bacterial counting using agar culture technique.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gozlan FS Mohamed; Phone Number: +201033766933; Email: gozlan.fouad@dentistry.cu.edu.eg
• Study Contact Backup: Name: Gozlan Fouad; Email: gozlan.fouad@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Systemically healthy patient (ASA I, II).
2. Age between 20 and 40 years.
3. Male or female.
4. Patient who is able to sign and comprehend the pain scale (committed patient).

5. 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).

Exclusion criteria:

1. Medically compromised patients (ASA III or IV).

2. 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.
3. Patients who could not interpret the NRS.
4. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
5. History of intolerance to NSAIDs.

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
Active Comparator: Control group; in this group the teeth will be irrigated with 2.5% Sodium Hypochlorite (gold standard)	Other: sodium hypochlorite; As a root canal irrigant
Experimental: Experimental group; in this group the teeth will be irrigated with 10% V. Nelotica (Herbal irrigant)	Other: Vachellia Nelotica; As a root canal irrigant (herbal); Other Names: Babul

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial load reduction	Bacterial counting using agar culture technique.	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.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Gozlan FS Mohamed, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Estimated): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Necrosis; Dental Pulp Necrosis; Anti-Infective Agents; Disinfectants; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: GFSMohamed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not chosen yet

Drug and device information, study documents

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