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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 46
- Primary Endpoint
- post operative pain.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Systemically healthy patient (ASA I, II).
- •Age between 20 and 40 years.
- •Male or female.
- •Patient who is able to sign and comprehend the pain scale (committed patient).
- •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
- •Medically compromised patients (ASA III or IV).
- •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.
- •Patients who could not interpret the NRS.
- •Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
- •History of intolerance to NSAIDs.
Arms & Interventions
Experimental group
in this group the teeth will be irrigated with 10% V. Nelotica (Herbal irrigant)
Intervention: Vachellia Nelotica (Other)
Control group
in this group the teeth will be irrigated with 2.5% Sodium Hypochlorite (gold standard)
Intervention: sodium hypochlorite (Other)
Outcomes
Primary Outcomes
post operative pain.
Time Frame: 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 Outcomes
- Bacterial load reduction(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.)
Investigators
Gozlan Fouad Saad Mohamed
Principal Investigator, master's degree student, Endodontic Department, Cairo University
Cairo University