HealthyPhase 1NCT06437262
Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva
A Phase 1 study testing 0.20% CHX gel on saliva, 0.20% CHX and Cymenol gel on saliva and 0.20% CHX gel on oral biofilm in people with Healthy and Saliva, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- What is being tested?
- 0.20% CHX gel on saliva, 0.20% CHX and Cymenol gel on saliva and 0.20% CHX gel on oral biofilm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 Jul 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy volunteers
- Age between 20-45 years
- Presence of minimum 24 permanent teeth
- No evidence of gingivitis or periodontitis (CPITN= 0)
- No presence of untreated caries at the start of the study
Who cannot join
- Smoker or ex-smoker
- Presence of dental protheses or orthodontic appliances
- Antibiotic treatment and/or routine use of oral antiseptics in the previous three months
- Presence of any systemic disease that could alter saliva production or composition
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782
About this study
Official title: Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine Gel on Oral Biofilm and Saliva
The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application.
- Being tested
- 0.20% CHX gel on saliva, 0.20% CHX and Cymenol gel on saliva, 0.20% CHX gel on oral biofilm, 0.20% CHX and Cymenol gel on oral biofilm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.20% CHX gel on salivaDrug
In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.
0.20% CHX and Cymenol gel on salivaDrug
In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.
0.20% CHX gel on oral biofilmDrug
Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.
0.20% CHX and Cymenol gel on oral biofilmDrug
Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.
| Study group | Role | What they receive |
|---|---|---|
| 0.20% CHX gel | Active comparator | Participants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application. Receives: Drug: 0.20% CHX gel on saliva; Drug: 0.20% CHX gel on oral biofilm |
| 0.20% CHX and Cymenol gel | Experimental | Participants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application. Receives: Drug: 0.20% CHX and Cymenol gel on saliva; Drug: 0.20% CHX and Cymenol gel on oral biofilm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intragel bacterial viability: baseline vs 5 minutes
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 minutes
Measured: Baseline, 5 minutes
Intragel bacterial viability: baseline vs 1 hour
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 1 hour
Measured: Baseline, 1 hour
Intragel bacterial viability: baseline vs 3 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 3 hours
Measured: Baseline, 3 hours
Intragel bacterial viability: baseline vs 5 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 hours
Measured: Baseline, 5 hours
Intragel bacterial viability: baseline vs 7 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 7 hours
Measured: Baseline, 7 hours
Intragel bacterial viability: 5 minutes vs 1 hour
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 1 hour
Measured: 5 minutes, 1 hour
Intragel bacterial viability: 5 minutes vs 3 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 3 hours
Measured: 5 minutes, 3 hours
Intragel bacterial viability: 5 minutes vs 5 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 5 hours
Measured: 5 minutes, 5 hours
Intragel bacterial viability: 5 minutes vs 7 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 7 hours
Measured: 5 minutes, 7 hours
Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Measured: Baseline
Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 minutes: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Measured: 5 minutes
Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Measured: 1 hour
Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Measured: 3 hours
Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Measured: 5 hours
Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Sep 2022
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Lacer S.A.
- Responsible party
- Principal investigator, Inmaculada Tomás, University of Santiago de Compostela
- Investigators
- Inmaculada Tomás, Prof, Principal investigator, University of Santiago de Compostela, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437262
- Sponsor's protocol ID
- 2021-CE161
- Status last verified
- Jul 2024
- First submitted
- 25 May 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine Gel on Oral Biofilm and Saliva
- ClinicalTrials.gov ID
- NCT06437262
- Acronym / sponsor ID
- 2021-CE161
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Lacer S.A.
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 31 May 2024 (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 objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.20% CHX gel | Active comparator | Drug: 0.20% CHX gel on saliva, Drug: 0.20% CHX gel on oral biofilmParticipants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application. |
| 0.20% CHX and Cymenol gel | Experimental | Drug: 0.20% CHX and Cymenol gel on saliva, Drug: 0.20% CHX and Cymenol gel on oral biofilmParticipants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systemically healthy volunteers
- Age between 20-45 years
- Presence of minimum 24 permanent teeth
- No evidence of gingivitis or periodontitis (CPITN= 0)
- No presence of untreated caries at the start of the study
Key exclusion criteria (4 listed)
- Smoker or ex-smoker
- Presence of dental protheses or orthodontic appliances
- Antibiotic treatment and/or routine use of oral antiseptics in the previous three months
- Presence of any systemic disease that could alter saliva production or composition
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 |
|---|---|---|
| 0.20% CHX gel on salivaIn vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points. | Drug | 0.20% CHX gel |
| 0.20% CHX and Cymenol gel on salivaIn vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points. | Drug | 0.20% CHX and Cymenol gel |
| 0.20% CHX gel on oral biofilmEx vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points. | Drug | 0.20% CHX gel |
| 0.20% CHX and Cymenol gel on oral biofilmEx vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points. | Drug | 0.20% CHX and Cymenol gel |
Primary outcome
Intragel bacterial viability: baseline vs 5 minutes
Time frame: Baseline, 5 minutes
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 minutes
Intragel bacterial viability: baseline vs 1 hour
Time frame: Baseline, 1 hour
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 1 hour
Intragel bacterial viability: baseline vs 3 hours
Time frame: Baseline, 3 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 3 hours
Intragel bacterial viability: baseline vs 5 hours
Time frame: Baseline, 5 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 hours
Intragel bacterial viability: baseline vs 7 hours
Time frame: Baseline, 7 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 7 hours
Intragel bacterial viability: 5 minutes vs 1 hour
Time frame: 5 minutes, 1 hour
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 1 hour
Intragel bacterial viability: 5 minutes vs 3 hours
Time frame: 5 minutes, 3 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 3 hours
Intragel bacterial viability: 5 minutes vs 5 hours
Time frame: 5 minutes, 5 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 5 hours
Intragel bacterial viability: 5 minutes vs 7 hours
Time frame: 5 minutes, 7 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 7 hours
Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Time frame: Baseline
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Time frame: 5 minutes
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 minutes: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Time frame: 1 hour
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Time frame: 3 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Time frame: 5 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
Time frame: 7 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
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 29 Jul 2024.
- 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.
Inmaculada Tomás, Prof principal investigator
University of Santiago de Compostela, Spain
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 0.20% CHX gel on saliva, 0.20% CHX and Cymenol gel on saliva and 0.20% CHX gel on oral biofilm in people with Healthy and Saliva, run by University of Santiago de Compostela at 1 site in Spain.
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 4 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 Jul 2024. 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 Spain. 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?
Intragel bacterial viability: baseline vs 5 minutes (time frame: Baseline, 5 minutes). The study lists 15 primary outcomes in all. 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 Jul 2024.