Root Canal InfectionPhase 1NCT06811779
Comparison of Effectiveness of Disinfectants
A Phase 1 study testing Sodium Hypochlorite and Chlorhexidine in people with Root Canal Infection, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This is a comparative experimental study to compare the efficacy of chemical disinfection agents , sodium hypochlorite and chlorhexidine gluconate in decontaminating gutta percha cones Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- Sodium Hypochlorite and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Mar 2024to 25 Jun 2024
- Phase
- Phase 1
- 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
- healthy individual age between 20-40 patient needed root canal therapy
Who cannot join
- patient not willing to participate in study participants with systemic disease patients with neuromuscular disorder
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Dentistry
Rawalpindi, Punjab Province, 46000
About this study
Official title: Comparison of Effectiveness of Sodium Hypochlorite and Chlorhexidine Gluconate for Disinfection of Gutta Percha Cones
This is a comparative experimental study to compare the efficacy of chemical disinfection agents , sodium hypochlorite and chlorhexidine gluconate in decontaminating gutta percha cones
Read the detailed description
The study design is a comparative study which was done to compare the efficacy of chemical disinfection agents on decontaminating the gutta percha cones .
In this study, 124 standardized size-80 gutta-percha (GP) cones (Dentsply, Germany) were used to assess the efficacy of chemical disinfectants.
The cones were first sterilized using ethylene oxide to ensure baseline sterility. Following sterilization, 124 cones were allocated into two experimental groups (n = 62 each) for contamination.
group A . gp were immersed in 20ml of Enterococcus faecalis solution group B . gp were immersed in 20 ml of human saliva in patients undergoing root canal therapy
samples were incubated at 37°C for 72 hours to ensure uniform and thorough contamination
after incubation period cones were dried and divide into subgroups based on disinfectant agent applied .
The cones were immersed in disinfectant agent for 1 min and 10 min . Cones were dried again and immersed in brain heard infusion broth samples were again incubated at 37°C for 72 hours The presence of bacterial growth was determined by assessing turbidity in the broth, indicating viable microorganisms.
- Conditions
- Root Canal Infection
- Being tested
- Sodium Hypochlorite, Chlorhexidine
- Keywords
- chemical disinfection, chlorhexidine gluconate, gutta percha, sodium hypochlorite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HypochloriteDrug
Sodium hypochlorite used in 5% concentration for disinfection
ChlorhexidineDrug
Chlorhexidine 0.2% concentration for disinfection
| Study group | Role | What they receive |
|---|---|---|
| Naocl group | Active comparator | In this group, the Gp cones would be submerged in 5% naocl solution for 5 minutes and then tested for biofilm removal and eradication of inoculated microorganisms. Receives: Drug: Sodium Hypochlorite |
| chlorhexidine group | Active comparator | In this group, the Gp cones would be submerged in 0.2% chlorhexidine solution for 5 minutes and then tested for biofilm removal and eradication of inoculated microorganisms. Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of disinfectants by assessing turbidity in broth using mann whitney test
Following disinfection, all gutta-percha (GP) cones were dried again with sterile gauze and placed individually into sterile test tubes containing 20 mL of fresh brain heart infusion (BHI) broth. The test tubes were incubated at 37°C for 72 hours. The presence of bacterial growth was determined by assessing turbidity in the broth, indicating viable microorganisms. Quantitative analysis of turbidity data was performed using the Mann-Whitney test and Kruskal-Wallis test to evaluate the effectiveness of the disinfectants across the groups.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start24 Mar 2024
- Primary completion24 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Amjad, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Hafiza Hira Amjad, BDS, Principal investigator, Armed Forces Institute of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811779
- Sponsor's protocol ID
- Disinfection
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Sodium Hypochlorite and Chlorhexidine Gluconate for Disinfection of Gutta Percha Cones
- ClinicalTrials.gov ID
- NCT06811779
- Acronym / sponsor ID
- Disinfection
- Conditions
- Root Canal Infection
- Keywords
- chemical disinfection, chlorhexidine gluconate, gutta percha, sodium hypochlorite
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 6 Feb 2025 (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.
This is a comparative experimental study to compare the efficacy of chemical disinfection agents , sodium hypochlorite and chlorhexidine gluconate in decontaminating gutta percha cones
Detailed description
The study design is a comparative study which was done to compare the efficacy of chemical disinfection agents on decontaminating the gutta percha cones .
In this study, 124 standardized size-80 gutta-percha (GP) cones (Dentsply, Germany) were used to assess the efficacy of chemical disinfectants.
The cones were first sterilized using ethylene oxide to ensure baseline sterility. Following sterilization, 124 cones were allocated into two experimental groups (n = 62 each) for contamination.
group A . gp were immersed in 20ml of Enterococcus faecalis solution group B . gp were immersed in 20 ml of human saliva in patients undergoing root canal therapy
samples were incubated at 37°C for 72 hours to ensure uniform and thorough contamination
after incubation period cones were dried and divide into subgroups based on disinfectant agent applied .
The cones were immersed in disinfectant agent for 1 min and 10 min . Cones were dried again and immersed in brain heard infusion broth samples were again incubated at 37°C for 72 hours The presence of bacterial growth was determined by assessing turbidity in the broth, indicating viable microorganisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naocl group | Active comparator | Drug: Sodium HypochloriteIn this group, the Gp cones would be submerged in 5% naocl solution for 5 minutes and then tested for biofilm removal and eradication of inoculated microorganisms. |
| chlorhexidine group | Active comparator | Drug: ChlorhexidineIn this group, the Gp cones would be submerged in 0.2% chlorhexidine solution for 5 minutes and then tested for biofilm removal and eradication of inoculated microorganisms. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy individual age between 20-40 patient needed root canal therapy
Key exclusion criteria (1 listed)
- patient not willing to participate in study participants with systemic disease patients with neuromuscular disorder
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 |
|---|---|---|
| Sodium HypochloriteSodium hypochlorite used in 5% concentration for disinfection | Drug | Naocl group |
| ChlorhexidineChlorhexidine 0.2% concentration for disinfection | Drug | chlorhexidine group |
Primary outcome
effectiveness of disinfectants by assessing turbidity in broth using mann whitney test
Time frame: 24 weeks
Following disinfection, all gutta-percha (GP) cones were dried again with sterile gauze and placed individually into sterile test tubes containing 20 mL of fresh brain heart infusion (BHI) broth. The test tubes were incubated at 37°C for 72 hours. The presence of bacterial growth was determined by assessing turbidity in the broth, indicating viable microorganisms. Quantitative analysis of turbidity data was performed using the Mann-Whitney test and Kruskal-Wallis test to evaluate the effectiveness of the disinfectants across the groups.
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 6 Feb 2025.
- 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.
Hafiza Hira Amjad, BDS principal investigator
Armed Forces Institute of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Hypochlorite and Chlorhexidine in people with Root Canal Infection, run by Armed Forces Institute of Dentistry, Pakistan 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 1 inclusion and 1 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 6 Feb 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
effectiveness of disinfectants by assessing turbidity in broth using mann whitney test (time frame: 24 weeks). 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 6 Feb 2025.