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

Phase 2CompletedNCT02194023

Universitat Internacional de Catalunya200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

200

Conditions

Dental Plaque Side Effects

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UIC dental office, Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Outcomes

Primary Outcomes

Percentage of participants with greater reduction of plaque regrowth and side effects.

Time frame: Baseline to 4 days.

Data from ClinicalTrials.gov

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