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

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Necrotic Pulp; Post Operative Pain

Treatments: Other: sodium hypochlorite; Other: Vachellia Nelotica

Study type: Interventional

Funder types: Other

Identifiers

NCT06116214

GFSMohamed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Other: sodium hypochlorite

Experimental group

Experimental group

Description:

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

Treatment:

Other: Vachellia Nelotica