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Completed

NCT Number: NCT02194023

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

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.

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Key information

Conditions

Dental Plaque Dental Deposits Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Side Effects Stomatognathic Diseases Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UIC dental office, Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo: PCB

Drug

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

0.12%NF

Drug

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

Drug

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

Drug

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

Primary outcomes

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

    Time frame: Baseline to 4 days.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Collaborators

  • Dentaid SL

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2014
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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