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Not yet recruitingNCT06116214Updated Nov 3, 2023

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

A Phase 4 interventional study of Vachellia Nelotica and sodium hypochlorite in Necrotic Pulp and Post Operative Pain, sponsored by Cairo University. Not yet recruiting. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-03.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 37 studies in Dental Pulp Necrosis by Cairo University — 5 open to participants now, 5 under way, none of them phase 3. Dental Pulp Necrosis · Cairo University.

Planned enrollment
12th of 37
46 · median 42
Started
2023
with 3 others
Phase 4
2 of 37
1 open now
Registered
33rd of 37
by date

Among the 37 studies in Dental Pulp Necrosis by Cairo University, this one is the 12th largest by planned enrollment, is one of 4 that started in 2023, is one of 2 in phase 4, and was the 33rd registered.

Dental Pulp Necrosis

157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.

Browse Dental Pulp Necrosis studies →

Open to participants now

5 of the 37 studies in Dental Pulp Necrosis by Cairo University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 15 Dental Pulp Necrosis studies recruiting now, 6 (40%) set no upper age limit and 7 (47%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 20 Years to 40 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

Read the 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.

03

Conditions studied

  • Necrotic Pulp
  • Post Operative Pain
04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Systemically healthy patient (, 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

Exclusion criteria:

  1. Medically compromised patients ().
  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 disease and pregnant women will be also excluded.
  5. History of intolerance to NSAIDs.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Active comparator
    Control group

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

    Other: sodium hypochlorite

  • Experimental
    Experimental group

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

    Other: Vachellia Nelotica

Interventions

  • OtherVachellia Nelotica

    As a root canal irrigant (herbal)

    Also known as: Babul

  • Othersodium hypochlorite

    As a root canal irrigant

06

What researchers measure

Primary outcomes

  1. post operative pain.

    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.

    Time frame: At 6, 12, 24, and 48 hours postoperatively (post instrumentation and post obturation)

Secondary outcomes

  1. Bacterial load reduction

    Bacterial counting using agar culture technique.

    Time frame: 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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Not chosen yet

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2023; primary completion for Feb 2024, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2023
First posted
Nov 3, 2023
StartEst.
Nov 2023
Primary completionEst.
Feb 2024
CompletionEst.
Dec 2024
Last update
Nov 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06116214
Lead sponsor
Cairo University
Responsible party
Gozlan Fouad Saad Mohamed (Principal Investigator, master's degree student, Endodontic Department, Cairo University, Cairo University) — Principal investigator
First posted
Nov 3, 2023
Start date
Nov 2023 (estimated)
Primary completion
Feb 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Nov 3, 2023

Study contacts

Gozlan FS Mohamed
Contact
gozlan.fouad@dentistry.cu.edu.eg
+201033766933
Gozlan FS Mohamed
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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