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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06116214
Collaborator
(none)
46
2
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Vachellia Nelotica
  • Other: sodium hypochlorite
Phase 4

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
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control group

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

Other: sodium hypochlorite
As a root canal irrigant

Experimental: Experimental group

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

Other: Vachellia Nelotica
As a root canal irrigant (herbal)
Other Names:
  • Babul
  • Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.]

      Bacterial counting using agar culture technique.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    1. Patients who could not interpret the NRS.

    2. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.

    3. History of intolerance to NSAIDs.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Gozlan FS Mohamed, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gozlan Fouad Saad Mohamed, Principal Investigator, master's degree student, Endodontic Department, Cairo University, Cairo University
    ClinicalTrials.gov Identifier:
    NCT06116214
    Other Study ID Numbers:
    • GFSMohamed
    First Posted:
    Nov 3, 2023
    Last Update Posted:
    Nov 3, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2023