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

U

Universitat Internacional de Catalunya

Status and phase

Completed
Phase 2

Conditions

Dental Plaque
Side Effects

Treatments

Drug: 0.03%NF
Drug: 0.12%NF
Drug: PAT
Drug: Placebo: PCB

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02194023
PER-ECL-2011-06-NF

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 4 patient groups, including a placebo group

Placebo (PCB)
Placebo Comparator group
Description:
Placebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water)
Treatment:
Drug: Placebo: PCB
0.12%NF
Experimental group
Description:
0.12% Chlorhexidine digluconate new formulation
Treatment:
Drug: 0.12%NF
0.03%NF
Experimental group
Description:
0.03% Chlorhexidine digluconate new formulation
Treatment:
Drug: 0.03%NF
PAT (Perio-Aid Treatment)
Active Comparator group
Description:
Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain)
Treatment:
Drug: PAT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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