Necrotic PulpPhase 2/3NCT05146713
Effect of Propolis Nanoparticles on Postoperative Pain and Bacterial Reduction in Mandibular Premolars
A Phase 2/3 study testing Propolis nanoparticles extract solution and sodium hypochlorite in people with Necrotic Pulp, run by Cairo University.
Trial summary
The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- Propolis nanoparticles extract solution and sodium hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2022
- Phase
- Phase 2/3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systematically healthy patient (ASA I,II).
- Age between 20 and 55 years
- Male or female.
- Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with or without apical periodontitis.
- Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.
Who cannot join
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Teeth with:
- Immature roots
- Vital pulp tissues.
- Association with swelling.
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- 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 were, also, excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect Of Propolis Nanoparticles Versus Sodium Hypochlorite As Root Canal Irrigant On Postoperative Pain And Bacterial Reduction In Mandibular Premolars With Necrotic Pulps (A Randomized Clinical Trial)
The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.
- Conditions
- Necrotic Pulp
- Being tested
- Propolis nanoparticles extract solution, sodium hypochlorite
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis nanoparticles extract solutionDietary supplement
20 mg/ml propolis nanoparticles in the form of solution prepared from honeybee from various plants.
sodium hypochloriteDrug
2.5% sodium hypochlorite (household bleaching agent)
| Study group | Role | What they receive |
|---|---|---|
| Propolis nanoparticles extract solution | Experimental | Not described Receives: Dietary Supplement: Propolis nanoparticles extract solution |
| sodium hypochlorite | Active comparator | Not described Receives: Drug: sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
postoperative pain will be marked by the patient using the Numerical rating scale (NRS) chart which is an 11 point scale consisting of numbers from 0 through 10, where: 0: reading represents "no pain" 1-3: readings represent "mild pain" 4-6: readings represent "moderate pain" 7-10: readings represent "severe pain"
Measured: up to 48 hours postoperatively
Secondary outcomes (2)
Intracanal bacterial load change
The intracanal bacterial load change will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation.
Measured: Throughout the chemo-mechanical preparation of the canal.
Number of analgesic tablets taken by the patient after endodontic treatment
Measured: Up to 48 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Mohamed Saleh Elaguizy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146713
- Sponsor's protocol ID
- ENDO 3-7-1 CairoU
- Status last verified
- Dec 2021
- First submitted
- 17 Oct 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Propolis Nanoparticles Versus Sodium Hypochlorite As Root Canal Irrigant On Postoperative Pain And Bacterial Reduction In Mandibular Premolars With Necrotic Pulps (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05146713
- Acronym / sponsor ID
- ENDO 3-7-1 CairoU
- Conditions
- Necrotic Pulp
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Dec 2021 (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 clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis nanoparticles extract solution | Experimental | Dietary Supplement: Propolis nanoparticles extract solution |
| sodium hypochlorite | Active comparator | Drug: sodium hypochlorite |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systematically healthy patient (ASA I,II).
- Age between 20 and 55 years
- Male or female.
- Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with or without apical periodontitis.
- Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.
Key exclusion criteria (13 listed)
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Teeth with:
- Patients who could not interpret the NRS.
- Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
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 |
|---|---|---|
| Propolis nanoparticles extract solution20 mg/ml propolis nanoparticles in the form of solution prepared from honeybee from various plants. | Dietary supplement | Propolis nanoparticles extract solution |
| sodium hypochlorite2.5% sodium hypochlorite (household bleaching agent) | Drug | sodium hypochlorite |
Primary outcome
Postoperative pain
Time frame: up to 48 hours postoperatively
postoperative pain will be marked by the patient using the Numerical rating scale (NRS) chart which is an 11 point scale consisting of numbers from 0 through 10, where: 0: reading represents "no pain" 1-3: readings represent "mild pain" 4-6: readings represent "moderate pain" 7-10: readings represent "severe pain"
2 secondary outcomes
Intracanal bacterial load change
Time frame: Throughout the chemo-mechanical preparation of the canal.
Number of analgesic tablets taken by the patient after endodontic treatment
Time frame: Up to 48 hours postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propolis nanoparticles extract solution and sodium hypochlorite in people with Necrotic Pulp, 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 5 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 7 Dec 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Radwa Mohamed Saleh Elaguizy (+201091782522, radwa.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: up to 48 hours postoperatively). 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 7 Dec 2021.