Dental CariesNCT05361278
Evaluation of Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.
A study testing Chlorhexidine solution, Activated chlorhexidine solution and Chlorhexidine gel in people with Dental Caries and Infection, Bacterial, run by Damascus University at 1 site in Syria.
Trial summary
The process of removing bacteria and their products from the root canals is an essential step that is achieved through the combination of mechanical preparation and irrigation with chemicals. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries, Infection, Bacterial, Tooth, Deciduous
- What is being tested?
- Chlorhexidine solution, Activated chlorhexidine solution and Chlorhexidine gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jan 2021to 19 Feb 2022
- Phase
- Interventional
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Definitely positive or positive ratings of Frank scale.
- Physiological root resorption no more than the apical third
- Symptoms or signs of pulpal necrosis with or without radial lesions (swelling - fistua - abnormal movement).
- At least 2 mm of bone surrounding the permanent bud.
- Children who have not taken antibiotics in the past 3 months.
Who cannot join
- Systematic or mental disorders.
- Definitely negative or negative ratings of Frankel scale
- Existence external or internal abnormal absorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Irrigation Effectiveness for Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.
The process of removing bacteria and their products from the root canals is an essential step that is achieved through the combination of mechanical preparation and irrigation with chemicals. However, mechanical preparation alone can not reduce the microbial formations inside root canals, so at least about 35% of the root canal walls remain without the preparation tools reaching them.
Many irrigants were used to irrigate the root canals, as sodium hypochlorite and chlorhexidine are the most famous. Although most studies have proven the effectiveness of sodium hypochlorite with its different concentrations in accomplishing this task, some of them showed the inability of the irrigant fluid to eliminate Enterococcus faecalis inside the canals. These bacteria are highly resistant, and therefore endodontic treatment fails in the long term.
Read the detailed description
Bacteria and their products play an essential role in the initiation and persistence of endodontic diseases. Therefore, eliminating them and preventing the return of their effectiveness is the desired goal in any successful endodontic treatment in the short and long term.
Due to the fact that mechanical preparation of the root canal alone is not capable of removing the entire bacterial content, chemical irrigants were considered necessary to reduce the number of bacteria and toxins resulting from them. Until now, there is no irrigant capable of removing the entire bacterial content from the root canal.
Despite the many advantages of sodium hypochlorite, several studies have revealed the toxicity of the solution in high concentrations of it, and it tends to cause tissue irritation when it comes into contact with the apical tissues.
Chlorhexidine has been used for a long time in dentistry due to its antibacterial properties, long period of effect, and relatively low toxicity. This has prompted its use as an irrigant and an intra-canal dressing in endodontic treatment.
- Conditions
- Dental Caries, Infection, Bacterial, Tooth, Deciduous
- Being tested
- Chlorhexidine solution, Activated chlorhexidine solution, Chlorhexidine gel, Activated chlorhexidine gel, Sodium hypochlorite solution
- Keywords
- Anterior Primary Tetth, Infected canals, chlorhexidine, Sodium hypochlorite
- Medical subject headings
- Dental Caries, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine solutionOther
- Irrigate the root canal with 1 ml of 2% CHx solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle.
- Irrigate the root canal with 3 ml of the solution after using the last file.
- Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine solution.
- Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
- Follow-up of endodontic treatment procedures for the treated tooth.
Activated chlorhexidine solutionOther
- Irrigate the root canal with 1 ml of 2% CHx solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle with activation using an ultrasonic irrigation head.
- Irrigate the root canal with 3 ml of the solution after using the last file with activation using an ultrasonic irrigation head.
- Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine solution.
- Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
- Follow-up of endodontic treatment procedures for the treated tooth.
Chlorhexidine gelOther
- Irrigate the root canal with 1 ml of 2% CHx gel between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle.
- Irrigate the root canal with 3 ml of the gel after using the last file.
- Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine gel.
- Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
- Follow-up of endodontic treatment procedures for the treated tooth.
Activated chlorhexidine gelOther
- Irrigate the root canal with 1 ml of 2% CHx gel between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle with activation using an ultrasonic irrigation head.
- Irrigate the root canal with 3 ml of the gel after using the last file with activation using an ultrasonic irrigation head.
- Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine gel.
- Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
- Follow-up of endodontic treatment procedures for the treated tooth.
Sodium hypochlorite solutionOther
- Irrigate the root canal with 1 ml of 5.25% sodium hypochlorite solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle.
- Irrigate the root canal with 3 ml of the solution after using the last file.
- Irrigating the canal with 3 ml of 5% sodium thiosulfate solution to remove residual of sodium hypochlorite.
- Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
- Follow-up of endodontic treatment procedures for the treated tooth.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine irrigation solution | Experimental | CHx 2% solution will be used. Receives: Other: Chlorhexidine solution |
| Activated chlorhexidine irrigation solution | Experimental | CHx 2% solution will be used with ultrasonic activation. Receives: Other: Activated chlorhexidine solution |
| Chlorhexidine irrigation gel | Experimental | CHx 2% gel will be used. Receives: Other: Chlorhexidine gel |
| Activated chlorhexidine irrigation gel | Experimental | CHx 2% gel will be used with ultrasonic activation. Receives: Other: Activated chlorhexidine gel |
| Sodium hypochlorite irrigation solution | Other | NaOCl 5,25% solution will be used. Receives: Other: Sodium hypochlorite solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logarithmic reduction of bacterial count within the root canal of chlorhexidine solution.
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Measured: 24 hours after sample incubation
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine solution.
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Measured: 24 hours after sample incubation
Logarithmic reduction of bacterial count within the root canal of chlorhexidine gel.
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Measured: 24 hours after sample incubation
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine gel.
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Measured: 24 hours after sample incubation
Logarithmic reduction of bacterial count within the root canal of sodium hypochlorite solution.
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Measured: 24 hours after sample incubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start15 Jan 2021
- Primary completion21 Dec 2021
- Study completion19 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rahaf ِA kharsa, DDs, Principal investigator, MSc student in Pedodontics, University of DamascusMohannad G Laflouf, Phd, Study director, Professor of Pedodontics, Department of Pedodontics, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361278
- Sponsor's protocol ID
- UDDS-Pedo-02-2022
- Status last verified
- Apr 2022
- First submitted
- 29 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goud S, Aravelli S, Dronamraju S, Cherukuri G, Morishetty P. Comparative Evaluation of the Antibacterial Efficacy of Aloe Vera, 3% Sodium Hypochlorite, and 2% Chlorhexidine Gluconate Against Enterococcus faecalis: An In Vitro Study. Cureus. 2018 Oct 22;10(10):e3480. doi: 10.7759/cureus.3480.
PubMed 30648031Gomes BP, Ferraz CC, Vianna ME, Berber VB, Teixeira FB, Souza-Filho FJ. In vitro antimicrobial activity of several concentrations of sodium hypochlorite and chlorhexidine gluconate in the elimination of Enterococcus faecalis. Int Endod J. 2001 Sep;34(6):424-8. doi: 10.1046/j.1365-2591.2001.00410.x.
PubMed 11556507Ruksakiet K, Hanak L, Farkas N, Hegyi P, Sadaeng W, Czumbel LM, Sang-Ngoen T, Garami A, Miko A, Varga G, Lohinai Z. Antimicrobial Efficacy of Chlorhexidine and Sodium Hypochlorite in Root Canal Disinfection: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2020 Aug;46(8):1032-1041.e7. doi: 10.1016/j.joen.2020.05.002. Epub 2020 May 12.
PubMed 32413440Walia V, Goswami M, Mishra S, Walia N, Sahay D. Comparative Evaluation of the Efficacy of Chlorhexidine, Sodium Hypochlorite, the Diode Laser and Saline in Reducing the Microbial Count in Primary Teeth Root Canals - An In Vivo Study. J Lasers Med Sci. 2019 Fall;10(4):268-274. doi: 10.15171/jlms.2019.44. Epub 2019 Oct 1.
PubMed 31875118Tirali RE, Bodur H, Ece G. In vitro antimicrobial activity of sodium hypochlorite, chlorhexidine gluconate and octenidine dihydrochloride in elimination of microorganisms within dentinal tubules of primary and permanent teeth. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e517-22. doi: 10.4317/medoral.17566.
PubMed 22143724
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Irrigation Effectiveness for Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.
- ClinicalTrials.gov ID
- NCT05361278
- Acronym / sponsor ID
- UDDS-Pedo-02-2022
- Conditions
- Dental Caries, Infection, Bacterial, Tooth, Deciduous
- Keywords
- Anterior Primary Tetth, Infected canals, chlorhexidine, Sodium hypochlorite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 19 Feb 2022 (actual)
- First posted
- 4 May 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 process of removing bacteria and their products from the root canals is an essential step that is achieved through the combination of mechanical preparation and irrigation with chemicals. However, mechanical preparation alone can not reduce the microbial formations inside root canals, so at least about 35% of the root canal walls remain without the preparation tools reaching them.
Many irrigants were used to irrigate the root canals, as sodium hypochlorite and chlorhexidine are the most famous. Although most studies have proven the effectiveness of sodium hypochlorite with its different concentrations in accomplishing this task, some of them showed the inability of the irrigant fluid to eliminate Enterococcus faecalis inside the canals. These bacteria are highly resistant, and therefore endodontic treatment fails in the long term.
Detailed description
Bacteria and their products play an essential role in the initiation and persistence of endodontic diseases. Therefore, eliminating them and preventing the return of their effectiveness is the desired goal in any successful endodontic treatment in the short and long term.
Due to the fact that mechanical preparation of the root canal alone is not capable of removing the entire bacterial content, chemical irrigants were considered necessary to reduce the number of bacteria and toxins resulting from them. Until now, there is no irrigant capable of removing the entire bacterial content from the root canal.
Despite the many advantages of sodium hypochlorite, several studies have revealed the toxicity of the solution in high concentrations of it, and it tends to cause tissue irritation when it comes into contact with the apical tissues.
Chlorhexidine has been used for a long time in dentistry due to its antibacterial properties, long period of effect, and relatively low toxicity. This has prompted its use as an irrigant and an intra-canal dressing in endodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine irrigation solution | Experimental | Other: Chlorhexidine solutionCHx 2% solution will be used. |
| Activated chlorhexidine irrigation solution | Experimental | Other: Activated chlorhexidine solutionCHx 2% solution will be used with ultrasonic activation. |
| Chlorhexidine irrigation gel | Experimental | Other: Chlorhexidine gelCHx 2% gel will be used. |
| Activated chlorhexidine irrigation gel | Experimental | Other: Activated chlorhexidine gelCHx 2% gel will be used with ultrasonic activation. |
| Sodium hypochlorite irrigation solution | Other | Other: Sodium hypochlorite solutionNaOCl 5,25% solution will be used. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Definitely positive or positive ratings of Frank scale.
- Physiological root resorption no more than the apical third
- Symptoms or signs of pulpal necrosis with or without radial lesions (swelling - fistua - abnormal movement).
- At least 2 mm of bone surrounding the permanent bud.
- Children who have not taken antibiotics in the past 3 months.
Key exclusion criteria (3 listed)
- Systematic or mental disorders.
- Definitely negative or negative ratings of Frankel scale
- Existence external or internal abnormal absorption.
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 |
|---|---|---|
| Chlorhexidine solution* Irrigate the root canal with 1 ml of 2% CHx solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle. * Irrigate the root canal with 3 ml of the solution after using the last file. * Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine solution. * Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear. * Follow-up of endodontic treatment procedures for the treated tooth. | Other | Chlorhexidine irrigation solution |
| Activated chlorhexidine solution* Irrigate the root canal with 1 ml of 2% CHx solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle with activation using an ultrasonic irrigation head. * Irrigate the root canal with 3 ml of the solution after using the last file with activation using an ultrasonic irrigation head. * Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine solution. * Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear. * Follow-up of endodontic treatment procedures for the treated tooth. | Other | Activated chlorhexidine irrigation solution |
| Chlorhexidine gel* Irrigate the root canal with 1 ml of 2% CHx gel between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle. * Irrigate the root canal with 3 ml of the gel after using the last file. * Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine gel. * Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear. * Follow-up of endodontic treatment procedures for the treated tooth. | Other | Chlorhexidine irrigation gel |
| Activated chlorhexidine gel* Irrigate the root canal with 1 ml of 2% CHx gel between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle with activation using an ultrasonic irrigation head. * Irrigate the root canal with 3 ml of the gel after using the last file with activation using an ultrasonic irrigation head. * Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine gel. * Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear. * Follow-up of endodontic treatment procedures for the treated tooth. | Other | Activated chlorhexidine irrigation gel |
| Sodium hypochlorite solution* Irrigate the root canal with 1 ml of 5.25% sodium hypochlorite solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle. * Irrigate the root canal with 3 ml of the solution after using the last file. * Irrigating the canal with 3 ml of 5% sodium thiosulfate solution to remove residual of sodium hypochlorite. * Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear. * Follow-up of endodontic treatment procedures for the treated tooth. | Other | Sodium hypochlorite irrigation solution |
Primary outcome
Logarithmic reduction of bacterial count within the root canal of chlorhexidine solution.
Time frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine solution.
Time frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Logarithmic reduction of bacterial count within the root canal of chlorhexidine gel.
Time frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine gel.
Time frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
Logarithmic reduction of bacterial count within the root canal of sodium hypochlorite solution.
Time frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
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 4 May 2022.
- Background: PubMed 30648031Goud S, Aravelli S, Dronamraju S, Cherukuri G, Morishetty P. Comparative Evaluation of the Antibacterial Efficacy of Aloe Vera, 3% Sodium Hypochlorite, and 2% Chlorhexidine Gluconate Against Enterococcus faecalis: An In Vitro Study. Cureus. 2018 Oct 22;10(10):e3480. doi: 10.7759/cureus.3480.
- Background: PubMed 11556507Gomes BP, Ferraz CC, Vianna ME, Berber VB, Teixeira FB, Souza-Filho FJ. In vitro antimicrobial activity of several concentrations of sodium hypochlorite and chlorhexidine gluconate in the elimination of Enterococcus faecalis. Int Endod J. 2001 Sep;34(6):424-8. doi: 10.1046/j.1365-2591.2001.00410.x.
- Background: PubMed 32413440Ruksakiet K, Hanak L, Farkas N, Hegyi P, Sadaeng W, Czumbel LM, Sang-Ngoen T, Garami A, Miko A, Varga G, Lohinai Z. Antimicrobial Efficacy of Chlorhexidine and Sodium Hypochlorite in Root Canal Disinfection: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2020 Aug;46(8):1032-1041.e7. doi: 10.1016/j.joen.2020.05.002. Epub 2020 May 12.
- Background: PubMed 31875118Walia V, Goswami M, Mishra S, Walia N, Sahay D. Comparative Evaluation of the Efficacy of Chlorhexidine, Sodium Hypochlorite, the Diode Laser and Saline in Reducing the Microbial Count in Primary Teeth Root Canals - An In Vivo Study. J Lasers Med Sci. 2019 Fall;10(4):268-274. doi: 10.15171/jlms.2019.44. Epub 2019 Oct 1.
- Background: PubMed 22143724Tirali RE, Bodur H, Ece G. In vitro antimicrobial activity of sodium hypochlorite, chlorhexidine gluconate and octenidine dihydrochloride in elimination of microorganisms within dentinal tubules of primary and permanent teeth. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e517-22. doi: 10.4317/medoral.17566.
- 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.
Rahaf ِA kharsa, DDs principal investigator
MSc student in Pedodontics, University of Damascus
Mohannad G Laflouf, Phd study director
Professor of Pedodontics, Department of Pedodontics, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine solution, Activated chlorhexidine solution and Chlorhexidine gel in people with Dental Caries and Infection, Bacterial, run by Damascus University at 1 site in Syria.
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 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 4 May 2022. 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 Syria. 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?
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?
Logarithmic reduction of bacterial count within the root canal of chlorhexidine solution. (time frame: 24 hours after sample incubation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05361278, which also lists 5 linked publications.
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 4 May 2022.