Dental Pulp NecrosisNCT03668899
Antimicrobial Efficacy of Four Different Irrigation Protocols
A study testing irrigation in people with Dental Pulp Necrosis, run by Cairo University at 1 site in Egypt.
Trial summary
proper disinfection of root canal system before obturation is a must for long term success of endodontic treatment, therefore a proper irrigant is mandatory, therefore investigators are studying the antibacterial effects of 4 different irrgating solutions in root canal treatment of patients diagnosed with necrotic… Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Necrosis
- What is being tested?
- irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2020to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's age between 22-45 years.
- Both male and female.
- Patient who are medically free and with good health
- Necrotic Mandibular posterior teeth
Who cannot join
- Pregnant females.
- Teeth with vital inflamed pulps, symptomatic periapical abscess and facial cellulitis, periodontally diseased and hopeless teeth.
- Teeth with previous fillings and/ or previous endodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Antimicrobial Efficacy of Nano Chitosan, Chlorhexidine, Chlorhexidine/ Nano Chitosan Combination Versus Sodium Hypochlorite Irrigation in Patients With Necrotic Mandibular Posterior Teeth: A Randomized Clinical Trial
proper disinfection of root canal system before obturation is a must for long term success of endodontic treatment, therefore a proper irrigant is mandatory, therefore investigators are studying the antibacterial effects of 4 different irrgating solutions in root canal treatment of patients diagnosed with necrotic pulps in their mandibular posterior teeth. patients will be recruited from outpatient clinic of the endodontic department in cairo university. endodontic treatment will be carried out as usual and samples from the infected root canals will be collected before and after preparation to be cultivated and analyzed at the laboratories of microbiology of faculty of medicine, cairo university
Read the detailed description
Title:
Assessment of Antimicrobial Efficacy of Nano Chitosan, Chlorhexidine, Chlorhexidine/ Nano Chitosan Combination versus Sodium Hypochlorite Irrigation in Patients with Necrotic Mandibular Posterior Teeth: A Randomized Clinical Trial
Introduction
- Background
Bacteria play a major role in the pathogenesis of apical periodontitis; therefore, success of endodontic treatment is dependent on its complete eradication before obturation1.
It has been established that no instrumentation technique can sufficiently eradicate bacteria from the root canal system without proper irrigation. the success rate of endodontic treatment was claimed to be approximately 10-15% lower for teeth which yield a positive culture before obturation than for teeth which yield a negative culture1.
A verity of irrigating solutions has been introduced and investigated for proper disinfection during endodontic treatment of which sodium hypochlorite (NaOCl) was considered the most popular of all available solutions for its superior antimicrobial effects and tissue dissolving abilities2.
The inability of NaOCl to remove smear layer advocated the use of a chelating agent like EDTA or Citric acid for removal of smear layer after chemo-mechanical preparation3. Yet this wasn't the only downside to the use of NaOCl as the main irrigant, toxicity and irritation to the periapical tissues, burning of the surrounding oral tissues and the weakening effect on dentin flexural strength are also important disadvantages of NaOCl4,5.
Chlorhexidine (CHX), is another popular irrigant which has a broad-spectrum antimicrobial activity plus substantivity, yet it has no tissue dissolving abilities of any kind6. Several studies compared the antimicrobial activity of NaOCl and CHX, some studies showed CHX to be superior to NaOCl7 other studies concluded that it had no added effect to those of NaOCl and that hypochlorite more often achieved negative cultures than CHX8 and several studies proved them both to be similarly effective9.
A wide variety of natural solutions used for irrigation has emerged in order to overcome the downsides of NaOCl including Chitosan nanoparticles. Chitosan nanoparticles are known to have a good antimicrobial activity as well as a chelating effect which will allow for eradication of bacteria and removal of smear layer in the same time10.
- Rationale A. The intervention benefits and databases search results Sodium hypochlorite (NaOCl); the gold standard for irrigation has many disadvantages including irritation of the periapical tissues and burning of surrounding tissues4,5. Therefore, the present study aims to explore new irrigating solutions probably more effective and less irritating to the periapical tissues than NaOCl.
Recent studies have shed the light on a wide range of natural substances like Chitosan, Propolis, and other herbal solutions that are claimed to be as effective against bacteria as NaOCl and less toxic and less irritant4,and also introduced nanoparticles with their known antimicrobial capabilities as endodontic irrigants10,15.
Besides its antimicrobial activity, Chitosan nanoparticles showed promising chelating abilities; Porchena et al suggested that CNPs irrigation was superior to NaOCl in that as well as inhibiting bacterial growth it also can remove the smear layer effectively10.
An in vitro study in 2017 claimed that the combination of 2% Chlorhexidine and 2% Chitosan is as effective as NaOCl against E. Faecalis in biofilms5.
- The benefits of this study to the population and clinicians It is well established that the most probable cause failure of endodontic treatment is the presence of a persisting infection. Therefore, it is important that chemo-mechanical canal preparation be directed towards complete eradication of all bacteria from the root canal system so that the best possible prognosis can be achieved in endodontic treatment.
Natural alternatives to sodium hypochlorite (NaOCl) can provide as efficient disinfection of the root canal system without the adverse effects of NaOCl on surrounding oral and periapical tissues. This may allow endodontists to perform an efficient and comfortable root canal treatments increasing the patients' confidence and creating a more positive attitude towards the dental profession.
Objective of the present study
The Aim of the current study is to compare the antimicrobial effects of Nano chitosan, Chlorhexidine and Chlorhexidine/ Nano Chitosan combination to sodium hypochlorite in patients with necrotic mandibular posterior teeth
PICO Format
- P: population Patients diagnosed with necrotic mandibular posteriors.
- I: intervention I1: Irrigation with nano chitosan I2: Irrigation with chlorhexidine I3: Irrigation with Chlorhexidine/ nano Chitosan combination
- C: control Irrigation with sodium hypochlorite (NaOCl)
- O: outcome
Primary Outcome
Antibacterial efficacy: will be assessed by counting the number of colony forming units (CFU) after cultivating the collected samples before and after irrigation (S1 and S2) for each patient.
Outcome Tool Unit Time antibacterial efficacy Number of CFUs Numerical data Samples collected before and after preparation and transferred to the laboratory for immediate cultivation.
Secondary outcome Postoperative pain: will be recorded on a visual analogue scale (VAS), pain intensity will be recorded preoperatively and postoperatively after 6, 12, 24,48, 72 hours and 7 days. The VAS consists of a10-cm line anchored by two extremes "No pain" and "pain as bad as could be", patient will be asked to choose the mark that represent their level of pain. Pain level will be assigned to one of 4 categorical scores: 1, None (0); 2, Mild (1-3); 3, Moderate (4-6); 4, Severe (7-10).
Outcome Tool Unit Time Postoperative pain Visual analogue scale VAS Categorial data Immediately after treatment and Up to 7 days after endodontic treatment
Research Question:
In necrotic mandibular posterior teeth, would irrigating the canals using either nano chitosan, chlorhexidine or a combination of nano chitosan and chlorhexidine versus sodium hypochlorite result in better canal disinfection and less postoperative pain?
- Conditions
- Dental Pulp Necrosis
- Being tested
- irrigation
- 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.
irrigationProcedure or surgery
irrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection
| Study group | Role | What they receive |
|---|---|---|
| Chitosan NPs group | Experimental | irrigation with Chitosan nanoparticles (final flush) Receives: Procedure: irrigation |
| Chlorhexidine group | Experimental | irrigation with CHX (final flush) Receives: Procedure: irrigation |
| Combination group | Experimental | irrigation with CHX/ nano Chitosan combination (final flush) Receives: Procedure: irrigation |
| Hypochlorite group | Active comparator | irrigation with NaOCL (final flush) Receives: Procedure: irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Colony Forming Units Per Millilitre
activity of the irrigating solution against bacteria in the root canal system, the less the number of colony forming units the better the irrigating solution is
Measured: 1 week after culture
Secondary outcomes (1)
Numerical Rating Scale
pain incidence and intensity after root canal treatment The NRS consists of an 11 points line anchored by two extremes "No pain" and "pain as bad as could be"
Measured: after 6 hours,12 hours, 24 hours, 48 hours, 72 hours and 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start25 Jan 2020
- Primary completion30 Apr 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental Pulp NecrosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Nasr, Cairo University
- Investigators
- Maha Nasr, Masters, Principal investigator, studying for PhD in Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668899
- Sponsor's protocol ID
- A
- Status last verified
- Jun 2025
- First submitted
- 11 Sep 2018
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Antimicrobial Efficacy of Nano Chitosan, Chlorhexidine, Chlorhexidine/ Nano Chitosan Combination Versus Sodium Hypochlorite Irrigation in Patients With Necrotic Mandibular Posterior Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03668899
- Acronym / sponsor ID
- A
- Conditions
- Dental Pulp Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 29 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
proper disinfection of root canal system before obturation is a must for long term success of endodontic treatment, therefore a proper irrigant is mandatory, therefore investigators are studying the antibacterial effects of 4 different irrgating solutions in root canal treatment of patients diagnosed with necrotic pulps in their mandibular posterior teeth. patients will be recruited from outpatient clinic of the endodontic department in cairo university. endodontic treatment will be carried out as usual and samples from the infected root canals will be collected before and after preparation to be cultivated and analyzed at the laboratories of microbiology of faculty of medicine, cairo university
Detailed description
Title:
Assessment of Antimicrobial Efficacy of Nano Chitosan, Chlorhexidine, Chlorhexidine/ Nano Chitosan Combination versus Sodium Hypochlorite Irrigation in Patients with Necrotic Mandibular Posterior Teeth: A Randomized Clinical Trial
Introduction
- Background
Bacteria play a major role in the pathogenesis of apical periodontitis; therefore, success of endodontic treatment is dependent on its complete eradication before obturation1.
It has been established that no instrumentation technique can sufficiently eradicate bacteria from the root canal system without proper irrigation. the success rate of endodontic treatment was claimed to be approximately 10-15% lower for teeth which yield a positive culture before obturation than for teeth which yield a negative culture1.
A verity of irrigating solutions has been introduced and investigated for proper disinfection during endodontic treatment of which sodium hypochlorite (NaOCl) was considered the most popular of all available solutions for its superior antimicrobial effects and tissue dissolving abilities2.
The inability of NaOCl to remove smear layer advocated the use of a chelating agent like EDTA or Citric acid for removal of smear layer after chemo-mechanical preparation3. Yet this wasn't the only downside to the use of NaOCl as the main irrigant, toxicity and irritation to the periapical tissues, burning of the surrounding oral tissues and the weakening effect on dentin flexural strength are also important disadvantages of NaOCl4,5.
Chlorhexidine (CHX), is another popular irrigant which has a broad-spectrum antimicrobial activity plus substantivity, yet it has no tissue dissolving abilities of any kind6. Several studies compared the antimicrobial activity of NaOCl and CHX, some studies showed CHX to be superior to NaOCl7 other studies concluded that it had no added effect to those of NaOCl and that hypochlorite more often achieved negative cultures than CHX8 and several studies proved them both to be similarly effective9.
A wide variety of natural solutions used for irrigation has emerged in order to overcome the downsides of NaOCl including Chitosan nanoparticles. Chitosan nanoparticles are known to have a good antimicrobial activity as well as a chelating effect which will allow for eradication of bacteria and removal of smear layer in the same time10.
- Rationale A. The intervention benefits and databases search results Sodium hypochlorite (NaOCl); the gold standard for irrigation has many disadvantages including irritation of the periapical tissues and burning of surrounding tissues4,5. Therefore, the present study aims to explore new irrigating solutions probably more effective and less irritating to the periapical tissues than NaOCl.
Recent studies have shed the light on a wide range of natural substances like Chitosan, Propolis, and other herbal solutions that are claimed to be as effective against bacteria as NaOCl and less toxic and less irritant4,and also introduced nanoparticles with their known antimicrobial capabilities as endodontic irrigants10,15.
Besides its antimicrobial activity, Chitosan nanoparticles showed promising chelating abilities; Porchena et al suggested that CNPs irrigation was superior to NaOCl in that as well as inhibiting bacterial growth it also can remove the smear layer effectively10.
An in vitro study in 2017 claimed that the combination of 2% Chlorhexidine and 2% Chitosan is as effective as NaOCl against E. Faecalis in biofilms5.
- The benefits of this study to the population and clinicians It is well established that the most probable cause failure of endodontic treatment is the presence of a persisting infection. Therefore, it is important that chemo-mechanical canal preparation be directed towards complete eradication of all bacteria from the root canal system so that the best possible prognosis can be achieved in endodontic treatment.
Natural alternatives to sodium hypochlorite (NaOCl) can provide as efficient disinfection of the root canal system without the adverse effects of NaOCl on surrounding oral and periapical tissues. This may allow endodontists to perform an efficient and comfortable root canal treatments increasing the patients' confidence and creating a more positive attitude towards the dental profession.
Objective of the present study
The Aim of the current study is to compare the antimicrobial effects of Nano chitosan, Chlorhexidine and Chlorhexidine/ Nano Chitosan combination to sodium hypochlorite in patients with necrotic mandibular posterior teeth
PICO Format
- P: population Patients diagnosed with necrotic mandibular posteriors.
- I: intervention I1: Irrigation with nano chitosan I2: Irrigation with chlorhexidine I3: Irrigation with Chlorhexidine/ nano Chitosan combination
- C: control Irrigation with sodium hypochlorite (NaOCl)
- O: outcome
Primary Outcome
Antibacterial efficacy: will be assessed by counting the number of colony forming units (CFU) after cultivating the collected samples before and after irrigation (S1 and S2) for each patient.
Outcome Tool Unit Time antibacterial efficacy Number of CFUs Numerical data Samples collected before and after preparation and transferred to the laboratory for immediate cultivation.
Secondary outcome Postoperative pain: will be recorded on a visual analogue scale (VAS), pain intensity will be recorded preoperatively and postoperatively after 6, 12, 24,48, 72 hours and 7 days. The VAS consists of a10-cm line anchored by two extremes "No pain" and "pain as bad as could be", patient will be asked to choose the mark that represent their level of pain. Pain level will be assigned to one of 4 categorical scores: 1, None (0); 2, Mild (1-3); 3, Moderate (4-6); 4, Severe (7-10).
Outcome Tool Unit Time Postoperative pain Visual analogue scale VAS Categorial data Immediately after treatment and Up to 7 days after endodontic treatment
Research Question:
In necrotic mandibular posterior teeth, would irrigating the canals using either nano chitosan, chlorhexidine or a combination of nano chitosan and chlorhexidine versus sodium hypochlorite result in better canal disinfection and less postoperative pain?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chitosan NPs group | Experimental | Procedure: irrigationirrigation with Chitosan nanoparticles (final flush) |
| Chlorhexidine group | Experimental | Procedure: irrigationirrigation with CHX (final flush) |
| Combination group | Experimental | Procedure: irrigationirrigation with CHX/ nano Chitosan combination (final flush) |
| Hypochlorite group | Active comparator | Procedure: irrigationirrigation with NaOCL (final flush) |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient's age between 22-45 years.
- Both male and female.
- Patient who are medically free and with good health
- Necrotic Mandibular posterior teeth
Key exclusion criteria (3 listed)
- Pregnant females.
- Teeth with vital inflamed pulps, symptomatic periapical abscess and facial cellulitis, periodontally diseased and hopeless teeth.
- Teeth with previous fillings and/ or previous endodontic treatment
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 |
|---|---|---|
| irrigationirrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection | Procedure or surgery | Chitosan NPs group, Chlorhexidine group, Combination group, Hypochlorite group |
Primary outcome
Number of Colony Forming Units Per Millilitre
Time frame: 1 week after culture
activity of the irrigating solution against bacteria in the root canal system, the less the number of colony forming units the better the irrigating solution is
1 secondary outcome
Numerical Rating Scale
Time frame: after 6 hours,12 hours, 24 hours, 48 hours, 72 hours and 7 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maha Nasr, Masters principal investigator
studying for PhD in Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing irrigation in people with Dental Pulp Necrosis, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Colony Forming Units Per Millilitre (time frame: 1 week after culture). 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 29 Jun 2025.