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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Dental Plaque, Side Effects

Intervention / Treatment
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* Drug: Placebo: PCB
* Drug: 0.12%NF
* Drug: 0.03%NF
* Drug: PAT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (PCB)<br>Placebo mouthrinse: physiological saline solution (0.9% w/w solution of NaCl in deionized water) | Drug: Placebo: PCB<br>* 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.<br>* Other names: saline solution;|
| Experimental: 0.12%NF<br>0.12% Chlorhexidine digluconate new formulation | Drug: 0.12%NF<br>* 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.<br>|
| Experimental: 0.03%NF<br>0.03% Chlorhexidine digluconate new formulation | Drug: 0.03%NF<br>* 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.<br>|
| Active Comparator: PAT (Perio-Aid Treatment)<br>Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain) | Drug: PAT<br>* 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.<br>* Other names: Perio-Aid Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with greater reduction of plaque regrowth and side effects. |  | Baseline to 4 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingivitis, chlorhexidine digluconate, cetylpyridinium chloride, mouthrinse, dental plaque, de novo, in vivo