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

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

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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