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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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06116214
Enrollment
46
Registered
2023-11-03
Start date
2023-11-30
Completion date
2024-12-31
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotic Pulp, Post Operative Pain

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.

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.

Interventions

OTHERVachellia Nelotica

As a root canal irrigant (herbal)

OTHERsodium hypochlorite

As a root canal irrigant

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
post operative pain.At 6, 12, 24, and 48 hours postoperatively (post instrumentation and post obturation)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.

Secondary

MeasureTime frameDescription
Bacterial load reduction1 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.Bacterial counting using agar culture technique.

Contacts

Primary ContactGozlan FS Mohamed
gozlan.fouad@dentistry.cu.edu.eg+201033766933
Backup ContactGozlan Fouad
gozlan.fouad@dentistry.cu.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026