Irreversible PulpitisPhase 2NCT05306431
Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants
A Phase 2 study testing Polyhexamethylene biguanide and Sodium Hypochlorite in people with Irreversible Pulpitis, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
The aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment . Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Polyhexamethylene biguanide and Sodium Hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 30 Nov 2022
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients aged 18 to 50 years
- Both male and female patients
- Periodontally healthy teeth as determined by Periodontal Probing
- Patients with non-vital necrotic pulps as determined by Cold Test
- Patients with acute apical periodontitis determined by history and clinical examination
- Clinical Findings:
- Visual: Carious tooth decay Occlusion: Hyperocclusion Pulp vitality test: Negative Periapical radiograph: Caries involving pulp space and PDL widening Percussion Test: Positive Palpation Test: Negative
- Single rooted teeth as determined radiographically
Who cannot join
- • Multirooted teeth
- Teeth undergoing Re-endo treatments
- Teeth with root fractures and/ non restorable determined by clinical and radiographic examination
- Patients receiving antibiotic treatment in the past 3 months determined by history
- Patient with Diabetes determined by history
- Patient with history of smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants in Patients Reporting With Non-vital Necrotic Pulp and Apical Periodontitis
The aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .
Read the detailed description
This study will compare the antibacterial effectiveness of sodium hypochlorite and PHMB, to find out whether PHMB can be used as a substitute to NaOCL. Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity.
- Conditions
- Irreversible Pulpitis
- Being tested
- Polyhexamethylene biguanide, Sodium Hypochlorite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyhexamethylene biguanideDrug
Also called PHMB
Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant
Sodium HypochloriteDrug
Also called Bleach
A number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter
| Study group | Role | What they receive |
|---|---|---|
| Polyhexamethylene biguanide | Experimental | Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity. PHMB 0.2% has been recently used as a root canal irrigant in vitro and has shown promising results of antimicrobial effectiveness of > 99.9% for both PHMB and Sodium hypochlorite Receives: Drug: Polyhexamethylene biguanide |
| Sodium Hypochloride | Experimental | A number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter. Receives: Drug: Sodium Hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial load assessed by culture
Effectiveness of irrigant will be evaluated with the existence or non-existence of bacteria: Positive Effect = no bacteria exist, Negative Effect = bacteria exist. Bacterial analysis will be performed by counting the number of colonies of bacteria in the specimen: No growth = no colonies seen, Few growths = less than 10 colonies of bacteria seen, Moderate growth = less than 100 colonies more than 10 colonies of bacteria seen, Heavy growth = more than 100 colonies of bacteria seen.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- 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
- 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
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Abbasi, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306431
- Sponsor's protocol ID
- Root canal Irrigiant
- Status last verified
- Feb 2023
- First submitted
- 19 Mar 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants in Patients Reporting With Non-vital Necrotic Pulp and Apical Periodontitis
- ClinicalTrials.gov ID
- NCT05306431
- Acronym / sponsor ID
- Root canal Irrigiant
- Conditions
- Irreversible Pulpitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Apr 2022 (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 randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .
Detailed description
This study will compare the antibacterial effectiveness of sodium hypochlorite and PHMB, to find out whether PHMB can be used as a substitute to NaOCL. Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyhexamethylene biguanide | Experimental | Drug: Polyhexamethylene biguanidePolyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity. PHMB 0.2% has been recently used as a root canal irrigant in vitro and has shown promising results of antimicrobial effectiveness of > 99.9% for both PHMB and Sodium hypochlorite |
| Sodium Hypochloride | Experimental | Drug: Sodium HypochloriteA number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Patients aged 18 to 50 years
- Visual: Carious tooth decay Occlusion: Hyperocclusion Pulp vitality test: Negative Periapical radiograph: Caries involving pulp space and PDL widening Percussion Test: Positive Palpation Test: Negative
- Single rooted teeth as determined radiographically
Key exclusion criteria (6 listed)
- • Multirooted teeth
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 |
|---|---|---|
| Polyhexamethylene biguanideAlso: PHMBPolyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant | Drug | Polyhexamethylene biguanide |
| Sodium HypochloriteAlso: BleachA number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter | Drug | Sodium Hypochloride |
Primary outcome
Bacterial load assessed by culture
Time frame: 24 hours
Effectiveness of irrigant will be evaluated with the existence or non-existence of bacteria: Positive Effect = no bacteria exist, Negative Effect = bacteria exist. Bacterial analysis will be performed by counting the number of colonies of bacteria in the specimen: No growth = no colonies seen, Few growths = less than 10 colonies of bacteria seen, Moderate growth = less than 100 colonies more than 10 colonies of bacteria seen, Heavy growth = more than 100 colonies of bacteria seen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polyhexamethylene biguanide and Sodium Hypochlorite in people with Irreversible Pulpitis, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
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 8 inclusion and 6 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 21 Feb 2023. 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 Pakistan. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bacterial load assessed by culture (time frame: 24 hours). 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 21 Feb 2023.