Prevention & ControlSORCOSNCT05365737
Substantivity of Oral Rinses: Comparative Study
A study testing Oral rinse and Saliva harvest in people with Prevention & Control, run by University of Barcelona at 1 site in Spain.
Trial summary
A desirable quality of mouthrinses is substantivity an intrinsic feature of some molecules. Substantivity requires the adsorption of the agent on the oral surfaces and subsequently antimicrobial activity bacteriostatic along following hours. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention & Control
- What is being tested?
- Oral rinse and Saliva harvest
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 3 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult age (>18 y/o)
- good oral helath status
- minimum 24 evaluable teeth
- periodontal pockets ≤3 mm
- absence of caries \& periodontal haemorrage
Who cannot join
- smokers
- prosthesis or orthodontic devices
- Sjögren syndrome
- Antibiotic treatment in the last three months
- Systemic disease with alteration in the production and/or composition of the saliva
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Barcelona. Campus Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Substantivity of Mouthrinse Formulations Containing Cetylpyridinium Chloride and O-cymen-5-Ol Compared to Placebo on Salivary Microbiota
A desirable quality of mouthrinses is substantivity an intrinsic feature of some molecules. Substantivity requires the adsorption of the agent on the oral surfaces and subsequently antimicrobial activity bacteriostatic along following hours. This work aims to quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.
Read the detailed description
One of the desirable qualities of mouthrinses is substantivity, which is defined as the persistence capacity of its antimicrobial action over time in the mouth. This is an intrinsic feature of some molecules.
Such substantivity seems to require the adsorption of the agent on the buccal surfaces and subsequently exert a certain antimicrobial activity that seems to be mostly bacteriostatic.
Substantivity is the result of multiple factors controlling or altering adhesion, life period of antimicrobial capabilities, synergisms, antagonisms, and others. In order to improve substantivity and therefore increase antimicrobial effectiveness of CPC, o-Cymen-5-ol has recently been proposed to become incorporated to oral rinses. The aim of this work is to quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.
- Conditions
- Prevention & Control
- Being tested
- Oral rinse, Saliva harvest
- Keywords
- Mouth rinses, substanticity, oral infections, salivary microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral rinseOther
Participants use mouthwasher for a given time.
Saliva harvestOther
Non-stimulated saliva harvesting
| Study group | Role | What they receive |
|---|---|---|
| placebo oral rinse | Placebo comparator | Placebo comparator Volume Time Active molecule 15 mL 1 min No Receives: Other: Oral rinse; Other: Saliva harvest |
| CPC oral rinse | Active comparator | Volume Time Active molecule 15 mL 1 min CPC containing oral rinse Receives: Other: Oral rinse; Other: Saliva harvest |
| Cymenol oral rinse | Active comparator | Volume Time Active molecule 15 mL 1 min Cymenol containing oral rinse Receives: Other: Oral rinse; Other: Saliva harvest |
| CPC + Cymenol oral rinse | Active comparator | Volume Time Active molecule 15 mL 1 min CPC+cymenol containing oral rinse Receives: Other: Oral rinse; Other: Saliva harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary experiments
Measure of surviving bacteria by fluorimetry and confocal microscopy (Live \& dead)
Measured: one month
Secondary outcomes (1)
Substantivity of mouthrinse formulations containing Cetylpyridinium Chloride and O-cymen-5-Ol (single and combined) compared to Placebo on salivary microbiota
Measure of surviving bacteria by fluorimetry and confocal microscopy (Live \& dead) rinses plus placebo
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jan 2022
- Primary completion25 Jan 2022
- Study completion3 Feb 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 Prevention & ControlStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, double-blind, crossover study of the in situ antibacterial efficacy of o-Cymen-5-ol plus CPC, o-Cymen-5-ol and CPC on salivary microbiota.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Viñas, University of Barcelona
- Investigators
- Miguel Viñas, PhD, Study chair, University of Barcelona-Spain-
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365737
- Sponsor's protocol ID
- 33/2021
- Acronym
- SORCOS
- Status last verified
- May 2022
- First submitted
- 23 Feb 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aguilera FR, Vinas M, Sierra JM, Vinuesa T, R Fernandez de Henestrosa A, Furmanczyk M, Trullas C, Jourdan E, Lopez-Lopez J, Jorba M. Substantivity of mouth-rinse formulations containing cetylpyridinium chloride and O-cymen-5-ol: a randomized-crossover trial. BMC Oral Health. 2022 Dec 27;22(1):646. doi: 10.1186/s12903-022-02688-z.
PubMed 36575444
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substantivity of Mouthrinse Formulations Containing Cetylpyridinium Chloride and O-cymen-5-Ol Compared to Placebo on Salivary Microbiota
- ClinicalTrials.gov ID
- NCT05365737
- Acronym / sponsor ID
- SORCOS / 33/2021
- Conditions
- Prevention & Control
- Keywords
- Mouth rinses, substanticity, oral infections, salivary microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 9 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.
A desirable quality of mouthrinses is substantivity an intrinsic feature of some molecules. Substantivity requires the adsorption of the agent on the oral surfaces and subsequently antimicrobial activity bacteriostatic along following hours. This work aims to quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.
Detailed description
One of the desirable qualities of mouthrinses is substantivity, which is defined as the persistence capacity of its antimicrobial action over time in the mouth. This is an intrinsic feature of some molecules.
Such substantivity seems to require the adsorption of the agent on the buccal surfaces and subsequently exert a certain antimicrobial activity that seems to be mostly bacteriostatic.
Substantivity is the result of multiple factors controlling or altering adhesion, life period of antimicrobial capabilities, synergisms, antagonisms, and others. In order to improve substantivity and therefore increase antimicrobial effectiveness of CPC, o-Cymen-5-ol has recently been proposed to become incorporated to oral rinses. The aim of this work is to quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- randomized, double-blind, crossover study of the in situ antibacterial efficacy of o-Cymen-5-ol plus CPC, o-Cymen-5-ol and CPC on salivary microbiota.
| Arm | Type | Receives |
|---|---|---|
| placebo oral rinse | Placebo comparator | Other: Oral rinse, Other: Saliva harvestPlacebo comparator Volume Time Active molecule 15 mL 1 min No |
| CPC oral rinse | Active comparator | Other: Oral rinse, Other: Saliva harvestVolume Time Active molecule 15 mL 1 min CPC containing oral rinse |
| Cymenol oral rinse | Active comparator | Other: Oral rinse, Other: Saliva harvestVolume Time Active molecule 15 mL 1 min Cymenol containing oral rinse |
| CPC + Cymenol oral rinse | Active comparator | Other: Oral rinse, Other: Saliva harvestVolume Time Active molecule 15 mL 1 min CPC+cymenol containing oral rinse |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- adult age (>18 y/o)
- good oral helath status
- minimum 24 evaluable teeth
- periodontal pockets ≤3 mm
- absence of caries \& periodontal haemorrage
Key exclusion criteria (5 listed)
- smokers
- prosthesis or orthodontic devices
- Sjögren syndrome
- Antibiotic treatment in the last three months
- Systemic disease with alteration in the production and/or composition of the saliva
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 |
|---|---|---|
| Oral rinseParticipants use mouthwasher for a given time. | Other | CPC + Cymenol oral rinse, CPC oral rinse, Cymenol oral rinse, placebo oral rinse |
| Saliva harvestNon-stimulated saliva harvesting | Other | CPC + Cymenol oral rinse, CPC oral rinse, Cymenol oral rinse, placebo oral rinse |
Primary outcome
Preliminary experiments
Time frame: one month
Measure of surviving bacteria by fluorimetry and confocal microscopy (Live \& dead)
1 secondary outcome
Substantivity of mouthrinse formulations containing Cetylpyridinium Chloride and O-cymen-5-Ol (single and combined) compared to Placebo on salivary microbiota
Time frame: up to three months
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 11 May 2022.
- Derived from this study: PubMed 36575444Aguilera FR, Vinas M, Sierra JM, Vinuesa T, R Fernandez de Henestrosa A, Furmanczyk M, Trullas C, Jourdan E, Lopez-Lopez J, Jorba M. Substantivity of mouth-rinse formulations containing cetylpyridinium chloride and O-cymen-5-ol: a randomized-crossover trial. BMC Oral Health. 2022 Dec 27;22(1):646. doi: 10.1186/s12903-022-02688-z.
- 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.
Miguel Viñas, PhD study chair
University of Barcelona-Spain-
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral rinse and Saliva harvest in people with Prevention & Control, run by University of Barcelona 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 5 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 11 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 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.
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?
Preliminary experiments (time frame: one month). 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 NCT05365737, 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 11 May 2022; AzTrials last refreshed its copy on 3 Nov 2026.