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.

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 Overview

• Status: Completed
• Conditions: Dental Plaque; Side Effects
• Intervention / Treatment: Drug: Placebo: PCB; Drug: 0.12%NF; Drug: 0.03%NF; Drug: PAT

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Cugat, Barcelona, Spain, 08195
      • UIC dental office, Hospital General de Catalunya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Collaborators: Dentaid SL
• Investigators: Principal Investigator: Carolina Mor-Reinoso, Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 13, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: gingivitis; dental plaque; de novo; chlorhexidine digluconate; in vivo; cetylpyridinium chloride; mouthrinse
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: PER-ECL-2011-06-NF