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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116214
• Other study ID #: GFSMohamed
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: Gozlan FS Mohamed
• Phone: +201033766933
• Email: gozlan.fouad[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp
• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Vachellia Nelotica
As a root canal irrigant (herbal)
• sodium hypochlorite
As a root canal irrigant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.