Clinical trial NCT06116214: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Necrotic Pulp
Post Operative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: post operative pain.
timeFrame: At 6, 12, 24, and 48 hours postoperatively (post instrumentation and post obturation)
Secondary outcomes:
measure: Bacterial load reduction
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Gozlan FS Mohamed
role: PRINCIPAL_INVESTIGATOR
References: