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Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.

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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02194023
Enrollment
200
Registered
2014-07-18
Start date
2011-09-30
Completion date
2013-07-31
Last updated
2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque, Side Effects

Keywords

chlorhexidine digluconate, gingivitis, cetylpyridinium chloride, mouthrinse, dental plaque, de novo, in vivo

Brief 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 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.

Interventions

DRUGPlacebo: PCB

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.

DRUG0.12%NF

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.

DRUG0.03%NF

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.

DRUGPAT

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.

Sponsors

Dentaid SL
CollaboratorINDUSTRY
Universitat Internacional de Catalunya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frame
Percentage of participants with greater reduction of plaque regrowth and side effects.Baseline to 4 days.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026