Necrotic PulpPhase 4NCT06116214
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 study testing Vachellia Nelotica and sodium hypochlorite in people with Necrotic Pulp and Post Operative Pain, run by Cairo University.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp, Post Operative Pain
- What is being tested?
- Vachellia Nelotica and sodium hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
Gozlan Fouad contact
About this study
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.
- Conditions
- Necrotic Pulp, Post Operative Pain
- Being tested
- Vachellia Nelotica, sodium hypochlorite
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vachellia NeloticaOther
Also called Babul
As a root canal irrigant (herbal)
sodium hypochloriteOther
As a root canal irrigant
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | in this group the teeth will be irrigated with 2.5% Sodium Hypochlorite (gold standard) Receives: Other: sodium hypochlorite |
| Experimental group | Experimental | in this group the teeth will be irrigated with 10% V. Nelotica (Herbal irrigant) Receives: Other: Vachellia Nelotica |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozlan Fouad Saad Mohamed, Cairo University
- Investigators
- Gozlan FS Mohamed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116214
- Sponsor's protocol ID
- GFSMohamed
- Status last verified
- Nov 2023
- First submitted
- 24 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not chosen yet
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06116214
- Acronym / sponsor ID
- GFSMohamed
- Conditions
- Necrotic Pulp, Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: sodium hypochloritein this group the teeth will be irrigated with 2.5% Sodium Hypochlorite (gold standard) |
| Experimental group | Experimental | Other: Vachellia Neloticain this group the teeth will be irrigated with 10% V. Nelotica (Herbal irrigant) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- Medically compromised patients (ASA III or IV).
- Teeth with:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vachellia NeloticaAlso: BabulAs a root canal irrigant (herbal) | Other | Experimental group |
| sodium hypochloriteAs a root canal irrigant | Other | Control group |
Primary outcome
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.
1 secondary outcome
Bacterial load reduction
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No. Not chosen yet
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gozlan Fouad contact
Gozlan FS Mohamed principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vachellia Nelotica and sodium hypochlorite in people with Necrotic Pulp and Post Operative Pain, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gozlan FS Mohamed (+201033766933, gozlan.fouad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain. (time frame: At 6, 12, 24, and 48 hours postoperatively (post instrumentation and post obturation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.