Postoperative PainPhase 2/3NCT03719261
Assessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal
A Phase 2/3 study testing chitosan nanoparticles and Sodium Hypochlorite in people with Postoperative Pain, run by Cairo University.
Trial summary
A randomized clinical trial that aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- chitosan nanoparticles and Sodium Hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Oct 2019
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adult Patients, both genders, aging from 18-45 years.
- Patients with permanent mature teeth (closed apex).
- Single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium.
- Patients should be free from any systemic disease.
- Patients with normal periodontal depth less or equal 3 mm.
- Patients who will agree to the consent and will commit to follow-up.
Who cannot join
- Patients with permanent immature teeth.
- Teeth with vital pulps.
- Patients with facial swelling or acute infection or pain on percussion
- Patients with fistula.
- Teeth with vertical root fractures, internal or external root resorption and calcification
- Teeth with periodontal involvement or periapical bone loss.
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- Patients with any systemic disease that may affect predictable outcome.
- Pregnant or lactating females.
- Non-restorable teeth.
About this study
Official title: Assessment of Postoperative Pain and Antibacterial Activity of Chitosan Nanoparticles Versus Sodium Hypochlorite as a Root Canal Irrigant in Infected Root Canal
A randomized clinical trial that aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal.
Read the detailed description
This trial aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal. initial pre-treatment root canal sample will be taken.These will be designated as sample no.1. after first sample, according to random sequence, the patients will be randomly assigned into two groups. In Group I: Sodium hypochlorite (NaOCL 2.5%) will be used during instrumentation of the canals.In Group II: chitosan nanoparticles (CS-np) will be used. after preparation, the sample no.2 will be taken.Pain will be assessed by giving the patient the numerical pain rating scale (NRS) to assess his pain at 24, 48 and 72 hours after the first visit.
- Conditions
- Postoperative Pain
- Being tested
- chitosan nanoparticles, Sodium Hypochlorite
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chitosan nanoparticlesDrug
Also called chitosan
Chitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group
Sodium HypochloriteDrug
Sodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group
| Study group | Role | What they receive |
|---|---|---|
| sodium hypochlorite | Active comparator | Sodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group Receives: Drug: Sodium Hypochlorite |
| chitosan nanoparticles | Experimental | Chitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group Receives: Drug: chitosan nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibacterial activity
antibacterial activity will be evaluated by Sampling and culture method. The samples will be subjected to microbiological analysis to ascertain their individual microbiological load after 24h, this will be analyzed by counting the colony forming units (CFUs).
Measured: two samples will be taken at the same visit of endodontic treatment at day 1, the outcome measures will be assessed after 24h. the data will be reported after study compeletion about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mahgoub, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719261
- Sponsor's protocol ID
- Sarah mahgoub
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to make the individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain and Antibacterial Activity of Chitosan Nanoparticles Versus Sodium Hypochlorite as a Root Canal Irrigant in Infected Root Canal
- ClinicalTrials.gov ID
- NCT03719261
- Acronym / sponsor ID
- Sarah mahgoub
- Conditions
- Postoperative Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 25 Oct 2018 (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.
A randomized clinical trial that aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal.
Detailed description
This trial aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal. initial pre-treatment root canal sample will be taken.These will be designated as sample no.1. after first sample, according to random sequence, the patients will be randomly assigned into two groups. In Group I: Sodium hypochlorite (NaOCL 2.5%) will be used during instrumentation of the canals.In Group II: chitosan nanoparticles (CS-np) will be used. after preparation, the sample no.2 will be taken.Pain will be assessed by giving the patient the numerical pain rating scale (NRS) to assess his pain at 24, 48 and 72 hours after the first 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 |
|---|---|---|
| sodium hypochlorite | Active comparator | Drug: Sodium HypochloriteSodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group |
| chitosan nanoparticles | Experimental | Drug: chitosan nanoparticlesChitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Young adult Patients, both genders, aging from 18-45 years.
- Patients with permanent mature teeth (closed apex).
- Single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium.
- Patients should be free from any systemic disease.
- Patients with normal periodontal depth less or equal 3 mm.
Key exclusion criteria (9 listed)
- Patients with permanent immature teeth.
- Teeth with vital pulps.
- Patients with facial swelling or acute infection or pain on percussion
- Patients with fistula.
- Teeth with vertical root fractures, internal or external root resorption and calcification
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 |
|---|---|---|
| chitosan nanoparticlesAlso: chitosanChitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group | Drug | chitosan nanoparticles |
| Sodium HypochloriteSodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group | Drug | sodium hypochlorite |
Primary outcome
antibacterial activity
Time frame: two samples will be taken at the same visit of endodontic treatment at day 1, the outcome measures will be assessed after 24h. the data will be reported after study compeletion about 1 year
antibacterial activity will be evaluated by Sampling and culture method. The samples will be subjected to microbiological analysis to ascertain their individual microbiological load after 24h, this will be analyzed by counting the colony forming units (CFUs).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Individual participant dataSharing planned: No. there is no plan to make the individual participant data available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing chitosan nanoparticles and Sodium Hypochlorite in people with Postoperative 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 6 inclusion and 9 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 25 Oct 2018. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antibacterial activity (time frame: two samples will be taken at the same visit of endodontic treatment at day 1, the outcome measures will be assessed after 24h. the data will be reported after study compeletion about 1 year). 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 25 Oct 2018.