Dental PlaquePhase 2NCT02194023
Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
A Phase 2 study testing 0.12%NF, 0.03%NF and PAT in people with Dental Plaque and Side Effects, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Side Effects
- What is being tested?
- 0.12%NF, 0.03%NF and PAT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Jul 2013
- Phase
- Phase 2
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years
- Good overall health without medical history or medications that could interfere with the study conduct.
- Minimum of 6 teeth per quadrant.
- Absence of probing depths ≥4mm.
Who cannot join
- Allergy to CHX or to CPC.
- Continuous use of CHX or of any other oral antiseptic in the months prior to the study.
- Any adverse medical background or long-term medications that could affect gingival conditions.
- Having taken antibiotics in the previous three months.
- Moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(Van der Weijden et al. 1994).
- Pregnancy or breastfeeding.
Show all 11Show fewer
- Smokers of more than 5 cigarettes per day.
- Orthodontic appliances.
- Fixed or removable prostheses.
- Systemic diseases that increase the risk for gingival diseases (diabetes mellitus, immunosuppression).
- Severe dental crowding.
Trial locations and contacts
1 site in 1 country.
Spain1 site
UIC dental office, Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: Inhibition of de Novo Plaque Formation and Side Effects of Two New Mouthrinse Formulations: 0.12% and 0.03% Chlorhexidine Digluconate, Respectively, in a 4-day Non-brushing Model. A Triple-blind, Randomized Clinical Trial.
In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula and 3) that these mouthrinses have no negative microbiological effects, and they control total bacterial loads.
- Conditions
- Dental Plaque, Side Effects
- Being tested
- Placebo: PCB, 0.12%NF, 0.03%NF, PAT
- Keywords
- chlorhexidine digluconate, gingivitis, cetylpyridinium chloride, mouthrinse, dental plaque, de novo, in vivo
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo: PCBDrug
Also called saline solution
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
0.12%NFDrug
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
0.03%NFDrug
Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
PATDrug
Also called Perio-Aid Treatment
Patients were asked to rinse every 12 hours, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (PCB) | Placebo comparator | Placebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water) Receives: Drug: Placebo: PCB |
| 0.12%NF | Experimental | 0.12% Chlorhexidine digluconate new formulation Receives: Drug: 0.12%NF |
| 0.03%NF | Experimental | 0.03% Chlorhexidine digluconate new formulation Receives: Drug: 0.03%NF |
| PAT (Perio-Aid Treatment) | Active comparator | Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain) Receives: Drug: PAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with greater reduction of plaque regrowth and side effects.
Measured: Baseline to 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Dentaid SL
- Responsible party
- Principal investigator, Carolina Mor, Universitat Internacional de Catalunya
- Investigators
- Carolina Mor-Reinoso, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194023
- Sponsor's protocol ID
- PER-ECL-2011-06-NF
- Status last verified
- Jul 2014
- First submitted
- 13 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of de Novo Plaque Formation and Side Effects of Two New Mouthrinse Formulations: 0.12% and 0.03% Chlorhexidine Digluconate, Respectively, in a 4-day Non-brushing Model. A Triple-blind, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02194023
- Acronym / sponsor ID
- PER-ECL-2011-06-NF
- Conditions
- Dental Plaque, Side Effects
- Keywords
- chlorhexidine digluconate, gingivitis, cetylpyridinium chloride, mouthrinse, dental plaque, de novo, in vivo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Dentaid SL
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Jul 2014 (estimated)
- 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.
In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula and 3) that these mouthrinses have no negative microbiological effects, and they control total bacterial loads.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo (PCB) | Placebo comparator | Drug: Placebo: PCBPlacebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water) |
| 0.12%NF | Experimental | Drug: 0.12%NF0.12% Chlorhexidine digluconate new formulation |
| 0.03%NF | Experimental | Drug: 0.03%NF0.03% Chlorhexidine digluconate new formulation |
| PAT (Perio-Aid Treatment) | Active comparator | Drug: PATCommercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-30 years
- Good overall health without medical history or medications that could interfere with the study conduct.
- Minimum of 6 teeth per quadrant.
- Absence of probing depths ≥4mm.
Key exclusion criteria (11 listed)
- Allergy to CHX or to CPC.
- Continuous use of CHX or of any other oral antiseptic in the months prior to the study.
- Any adverse medical background or long-term medications that could affect gingival conditions.
- Having taken antibiotics in the previous three months.
- Moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(Van der Weijden et al. 1994).
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: PCBAlso: saline solutionParticipants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes. | Drug | Placebo (PCB) |
| 0.12%NFParticipants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes. | Drug | 0.12%NF |
| 0.03%NFParticipants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes. | Drug | 0.03%NF |
| PATAlso: Perio-Aid TreatmentPatients were asked to rinse every 12 hours, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes. | Drug | PAT (Perio-Aid Treatment) |
Primary outcome
Percentage of participants with greater reduction of plaque regrowth and side effects.
Time frame: Baseline to 4 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 18 Jul 2014.
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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.
Carolina Mor-Reinoso principal investigator
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.12%NF, 0.03%NF and PAT in people with Dental Plaque and Side Effects, run by Universitat Internacional de Catalunya 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 4 inclusion and 11 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 18 Jul 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of participants with greater reduction of plaque regrowth and side effects. (time frame: Baseline to 4 days.). 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 18 Jul 2014.