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

Dental Plaque Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194023
• Other study ID #: PER-ECL-2011-06-NF
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2014
• Last updated: July 17, 2014
• Start date: September 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dental Plaque
• Side Effects

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	UIC dental office, Hospital General de Catalunya	Sant Cugat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya	Dentaid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with greater reduction of plaque regrowth and side effects.		Baseline to 4 days.	Yes