HealthyPhase 1NCT05521230
Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
A Phase 1 study testing Cymenol mouthwash in people with Healthy and Dental Plaque, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the Dentius Deep Plaque software Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Dental Plaque
- What is being tested?
- Cymenol mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 30 Apr 2022
- 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 of 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 dentures or orthodontic appliances
- Antibiotic treatment in the last 3 months or routine use of oral antiseptics
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: Randomised Clinical Trial on the Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
The objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the Dentius Deep Plaque software
- Conditions
- Healthy, Dental Plaque
- Being tested
- Placebo Mouthwash, Cymenol mouthwash
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo MouthwashDrug
Application of mouthwashes
Cymenol mouthwashDrug
Application of mouthwashes
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants rinsed 10 ml of placebo mouthwash for a period of 60 seconds, three times a day with an interval of 7-9 hours in between, for 4 days (period 1) Receives: Drug: Placebo Mouthwash |
| Cymenol (test) | Experimental | Participants applied a 10 ml rinse of 0.1% cymenol mouthwash for a period of 60 seconds, three times a day with a 7-9 hour interval in between, for 4 days (period 1) and 4 days more (period 2) Receives: Drug: Cymenol mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the plaque area: baseline vs 4 days
Change in the percentage of the tooth surface with dental plaque:baseline vs 4 days
Measured: Baseline, 4 days
Change in the plaque area: baseline vs 8 days
Change in the percentage of the tooth surface with dental plaque: baseline vs 8 days
Measured: Baseline, 8 days
Change in the plaque area: 4 days vs 8 days
Change in the percentage of the tooth surface with dental plaque: 4 days vs 8 days
Measured: 4 days, 8 days
Change in the growth rate of dental plaque area: baseline vs 4 days
Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 4 days
Measured: Baseline, 4 days
Change in the growth rate of dental plaque area: baseline vs 8 days
Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 8 days
Measured: Baseline, 8 days
Change in the growth rate of dental plaque area: 4 days vs 8 days
Change in the growth rate of dental plaque area (percentage area/hour): 4 days vs 8 days
Measured: 4 days vs 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Sep 2021
- Primary completion31 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 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
- NCT05521230
- Sponsor's protocol ID
- 2021_CE112
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suarez-Rodriguez B, Regueira-Iglesias A, Blanco-Pintos T, Balsa-Castro C, Vila-Blanco N, Carreira MJ, Tomas I. Short-term anti-plaque effect of a cymenol mouthwash analysed using the DenTiUS Deep Plaque software: a randomised clinical trial. BMC Oral Health. 2023 Aug 12;23(1):560. doi: 10.1186/s12903-023-03256-9.
PubMed 37573292
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial on the Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
- ClinicalTrials.gov ID
- NCT05521230
- Acronym / sponsor ID
- 2021_CE112
- Conditions
- Healthy, Dental Plaque
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Lacer S.A.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Aug 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 objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the Dentius Deep Plaque software
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo MouthwashParticipants rinsed 10 ml of placebo mouthwash for a period of 60 seconds, three times a day with an interval of 7-9 hours in between, for 4 days (period 1) |
| Cymenol (test) | Experimental | Drug: Cymenol mouthwashParticipants applied a 10 ml rinse of 0.1% cymenol mouthwash for a period of 60 seconds, three times a day with a 7-9 hour interval in between, for 4 days (period 1) and 4 days more (period 2) |
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 of 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 (3 listed)
- Smoker or ex-smoker
- Presence of dentures or orthodontic appliances
- Antibiotic treatment in the last 3 months or routine use of oral antiseptics
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 |
|---|---|---|
| Placebo MouthwashApplication of mouthwashes | Drug | Placebo |
| Cymenol mouthwashApplication of mouthwashes | Drug | Cymenol (test) |
Primary outcome
Change in the plaque area: baseline vs 4 days
Time frame: Baseline, 4 days
Change in the percentage of the tooth surface with dental plaque:baseline vs 4 days
Change in the plaque area: baseline vs 8 days
Time frame: Baseline, 8 days
Change in the percentage of the tooth surface with dental plaque: baseline vs 8 days
Change in the plaque area: 4 days vs 8 days
Time frame: 4 days, 8 days
Change in the percentage of the tooth surface with dental plaque: 4 days vs 8 days
Change in the growth rate of dental plaque area: baseline vs 4 days
Time frame: Baseline, 4 days
Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 4 days
Change in the growth rate of dental plaque area: baseline vs 8 days
Time frame: Baseline, 8 days
Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 8 days
Change in the growth rate of dental plaque area: 4 days vs 8 days
Time frame: 4 days vs 8 days
Change in the growth rate of dental plaque area (percentage area/hour): 4 days vs 8 days
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 30 Aug 2022.
- Derived from this study: PubMed 37573292Suarez-Rodriguez B, Regueira-Iglesias A, Blanco-Pintos T, Balsa-Castro C, Vila-Blanco N, Carreira MJ, Tomas I. Short-term anti-plaque effect of a cymenol mouthwash analysed using the DenTiUS Deep Plaque software: a randomised clinical trial. BMC Oral Health. 2023 Aug 12;23(1):560. doi: 10.1186/s12903-023-03256-9.
- 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 Cymenol mouthwash in people with Healthy and Dental Plaque, 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 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 30 Aug 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 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. Some participants in this study may receive a placebo. 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?
Change in the plaque area: baseline vs 4 days (time frame: Baseline, 4 days). The study lists 6 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 NCT05521230, which also lists 1 linked publication.
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 30 Aug 2022.