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

NCT ID: NCT06116214

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-12-31

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.

Conditions

Necrotic Pulp; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

sodium hypochlorite

Intervention Type: OTHER

As a root canal irrigant

Experimental group

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

Group Type: EXPERIMENTAL

Vachellia Nelotica

Intervention Type: OTHER

As a root canal irrigant (herbal)

Interventions

Vachellia Nelotica

As a root canal irrigant (herbal)

Intervention Type: OTHER

sodium hypochlorite

As a root canal irrigant

Intervention Type: OTHER

Other Intervention Names

Babul

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Gozlan Fouad Saad Mohamed

Principal Investigator, master's degree student, Endodontic Department, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gozlan FS Mohamed

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

Gozlan FS Mohamed

Role: CONTACT

gozlan.fouad@dentistry.cu.edu.eg

+201033766933

Gozlan Fouad

Role: CONTACT

gozlan.fouad@dentistry.cu.edu.eg

Other Identifiers

GFSMohamed

Identifier Type: -

Identifier Source: org_study_id